Friday, October 30, 2009

Industry Groups will Eat Consumer Advocates' Lunch at FDA Social Media Public Hearing


Speakers at FDA's upcoming November public hearing on social media have received the schedule of presentations, which you can find here.

Each speaker has 10 minutes, but some -- like myself -- were given two 10-minute slots. As you may know, I will present results from the survey I have been hosting (see here). Why some of us got two slots, I don't know. I plan to address several questions put forward by the FDA and requested 15-20 minutes (see my proposal (pdf) here). I thought they would say 10 minutes and that's all you get! Instead, FDA gave me two 10-minute time slots. Nice of them.

Fabio Gratton (@skypen) of Ignite Health, a marketing communications agency, sent me a spreadsheet that listed all the 55 unique presenters and characterized the services offered by each presenter's organization. I simplified Fabio's schema into the following 7 categories (the number in parentheses represents the number of speakers in each category):
  1. Search Engine (2)
  2. Trade Media (2)
  3. Pharma Company (4)
  4. Consumer Advocate (5)
  5. Industry Advocate (6)
  6. Health Website (8)
  7. Industry Service Provider (28)
Obviously, there's quite a skew towards industry groups, which can best be seen in the following pie chart:

pie chart


[NOTE: a few "Health Websites" may also represent the consumer and/or patient point of view. These include PatientsLikeMe and WEGO. Putting those two sites into the "Consumer Advocate" bin would increase the consumer slice of the pie to 13% vs. 9%.]

This distribution of speakers may be typical of FDA public hearings. After all, the FDA is not paying for speakers' expenses. Money talks because nobody walks to these things. Unfortunately, that means that consumers are under-represented.

Consumers, however, can submit written comments to the docket (see here). I have yet to see ANY submitted comments and I don't know if this is because there are none, or the FDA is keeping comments hidden from public view even though they promised otherwise. It would be a travesty if consumers do not have a voice in this process.

I think the preparations for this hearing have been pretty disorganized and hasty. It appears that not much planning has gone into it and I'm afraid that the whole experience will be anti-climatic. A series of 10-minute presentations one after another without dialogue seems quite numbing and UNEDUCATIONAL. FDA may be doing this more out of formality than necessity. Reading between those lines leads me to believe that FDA already has some draft guidelines on the drawing board and really doesn't need any public input.

Thursday, October 29, 2009

Social Media Best Practices for Pharma Are Needed, Whatever Happens at FDA

Many pharma eMarketing pundits and FDA policy wonks out there are already predicting that nothing much will come out of the upcoming public hearing on Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools (see "FDA Announces Public Hearing on Promotion of Drugs on Internet & via Social Media. This is NOT a Hoax!").

Rich Meyer, blogger over at World of DTC Marketing, says "So what do I expect from the FDA open hearings? A lot of self promotion ... the fact that they are having these hearings communicates a lack of understanding of how people are using the Internet for health information."

Meyer predicted several months ago that the FDA would never have such a hearing in the first place. Now that there is a public hearing scheduled and a public comment process underway, Meyer does not believe that DTC marketing as we know it will change. He may be right about that, but there will be some changes.

First of all, the mere fact that there will be a public hearing where approximately 62 people will be making presentations (see list-in-progress here), will lead to an increased awareness among the public of how the pharma industry may be tapping into social media to influence patients and physicians. Whenever the public becomes aware of potential problems, Congress is not far behind. And when Congress starts investigating, the pharma industry rolls out another set of voluntary guidelines for best practices.

Of course, the FDA could also issue regulatory guidelines for use of social media for Rx promotion. The jaded among us think that it may be years before that happens, if ever. I, however, believe the FDA already has some kind of draft guidelines in the works that it will publish before the end of 2010 (see "Expect FDA Social Media Draft Guidance Before End of 2010"). As I said before, this is NOT your father's FDA -- case in point: Jean-Ah Kang, special assistant to DDMAC director Thomas Abrams, picks up the phone when you call. She also sent out the e-mail invitation to speakers at 2:07 AM! That's dedication!

After the 1996 FDA public hearing on the Internet, a bunch of presenters -- including patient advocates -- got together to form the Internet Healthcare Coalition, a non-profit grassroots organization that created the eHealth Code of Ethics. Pharmaceutical companies were involved in that effort and it received much media attention.

So, a lot can happen as a result of FDA's public hearings: Increased public awareness, congressional investigations, new regulatory guidance, voluntary industry guidelines, codes of ethics, and perhaps even new regulations. These are significant changes that cannot be ignored.

Pharma marketers also cannot long ignore the lure of social media, whatever form it takes in the future.

Although, according to polls, a majority of consumers out there do not trust pharmaceutical companies, there are millions of patients who have been helped by the industry. Many of these are patient advocates involved in social media and they want conversations with pharma companies. They want to partner with pharma companies and vice versa. But there needs to be "rules" or "best practices" for carrying on these conversations.

I don't have the answers, but I am enjoying the questions and responses to the questions I am receiving from readers who have taken my survey (see here). I have reviewed one set of answers having to do with adverse event reporting and social media. I made this presentation (pdf) of the results at the recent ePatient Connections 2009 conference in Philadelphia this week. You can also read this article in the October, 2009, issue of Pharma Marketing News: "Social Media Adverse Event Reporting Safe Harbors." Use the discount code SM222 to get it FREE.

Wednesday, October 28, 2009

Expect FDA Social Media Draft Guidance Before End of 2010

Let me make a prediction: FDA's DDMAC will issue some version of draft guidance on the use of social medial for Rx drug/device promotion BEFORE the end of 2010. Just for the record, I tweeted about this last week (October 21, 2009; see here).

Yesterday, at the ePatient Connections 2009 conference, I was a member of the Regulatory Panel that also included my friend Preeti Pinto, MS, MT (ASCP), Head of Medical Education and Regulatory Compliance at AstraZeneca, and Paul Loebach, Project Manager, DDMAC. I never met Loebach before, but I liked him even though he never fully revealed what he has been doing at DDMAC for the past 18 years.

During that panel discussion, Loebach informed the audience that it was too late to request a seat at the upcoming November FDA public hearing on social media. Over 800 people applied for seats, but the meeting room can only accommodate 350. Pharmaceutical Executive Magazine, for example, won't have a seat (see "Fear and Loathing in Washington, DC").

Someone in the audience asked Loebach and other panel members what their thoughts were regarding some best practices for using social media to get information out to consumers/patients. I would have responded by pointing out that one best practice for using social media was not to push info out to an audience, but to engage members of that audience in dialogue. But I let Loebach answer the question -- I'll have more to say about social media best practices in a follow-up post.

Loebach, speaking for himself and not DDMAC, suggested it was "too early" to offer advice and that DDMAC was "still fishing for information." He also said something I thought was revealing: ie, "we have ideas." Of course, by law, DDMAC has to solicit opinions of the public before it issues guidance and that's what the November hearing is about. "We still need to hear from everybody, because we're on the other side of the fence and we can't think of all the issues that you all will come up with and all the ways to use social media that you will come up with in the future. I know a lot of you in the audience feel that this hearing coming up in November is long overdue, but we're still too early in the learning curve to start giving advice on what will work and what won't."

This prompted me to ask Loebach: "Do you personally think the FDA will come out with some kind of guidelines relating to social media by the end of 2010?"

After a brief dramatic pause, Loebach responded "Yeah, probably that's a good estimate -- by the end of 2010. But if it happens earlier, even better," said Loebach hopefully.

This is as close as you're going to get for an official estimate of when FDA may publish social media guidelines. I happen to believe it is accurate not just because of what Loebach said, but because the FDA needs to prove that it's not your father's FDA. The new FDA leaders are younger than the previous leaders. They are smart people who believe in and have grown up using new media tools like social media. Besides, the FDA will lose tremendous face and credibility if, for the second time, they fail to act after calling a public hearing on the use of the Internet. This time they mean business.

Tuesday, October 27, 2009

Fear and Loathing in Washington, DC


We were somewhere around Bethesda on the edge of Washington, DC when reality began to take hold. I remember saying something like "I feel a bit lightheaded; maybe you should drive..." And suddenly there was a terrible roar all around us and the sky was full of what looked like huge bats, all swooping and screeching and diving around the car, which was going about a hundred miles an hour with the top down to DC. And a voice was screaming: "Holy Jesus! What are these goddamn animals?"

That’s how I imagine my next road trip will be like on the evening of November 11, 2009, as I head down to the FDA’s public hearing on the “Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools.”

I was thinking of wearing my Hunter S. Thompson Halloween costume to the meeting, but too many people told me they did not like the yellow Hawaiian shirt. It did, however, get me recognized at the recent ExL Pharma Digital Pharma meeting. Not that I needed it. When a panel member asked if Novo Nordisk’s Levemir-branded twitter account could be more effective, someone yelled out “Ask John Mack!” I think he read this: "Novo Nordisk's Branded (Levemir) Tweet is Sleazy Twitter Spam!"

But I digress. I will have my 15 minutes of fame (literally!) at the November FDA hearing when I give my presentation in front of the DDMAC luminaries and the audience stuffed in the wifi-cell-phone-challenged meeting room of the National Transportation Safety Board Conference Center.

As luck would have it, some of my trade press competition – ie, Pharmaceutical Executive Magazine – was a bit tardy in posting a request to attend. “Just got shut down for a spot at the FDA social media forum. So much for trade press getting preferential treatment,” said @PharmExecMag in a Tweet. In this Web 2.0, Twitter world, if you snooze, you lose, is all I have to say.

Meanwhile, I made all my preparations for attending between September 19 and 21. First, I reserved a room at L’Enfant Plaza Hotel because that's crucial. Even if couldn't get a seat inside, I could still cause some trouble outside selling this T-shirt. BTW, I did notice a Holiday Inn nearby when I was in DC last week, but there are no rooms at the Inn.

Even before the Fed Register Docket was open for comments, I sent a snail mail letter to FDA requesting a seat. That was Sunday, September 20. One of my Twitter pals said he sent his letter by overnight FedEx. I wasn’t that paranoid, but I did call the FDA on Monday just in case.

When I called, Jean-Ah Kang, special assistant to DDMAC director Thomas Abrams, picked up the phone. After a few more calls, we became phone buddies. I asked her a lot of questions: about recording the meeting, whether or not there will be live webcasts, and if WI-FI access was available in the room.


Unfortunately, there will be no WI-FI or cell phone access in the meeting room, but you can go outside for that, Kang said. This reminds me of the Cary Grant movie His Girl Friday where reporters in fedoras rushed out of the courtroom and ran to the press room to call in their stories. There is a press room just outside the hearing room at the NTSB Center, but I haven’t been able to determine who can use this, what facilities it has, and why I would want to be holed up in there when all the action is happening up front in the court of public opinion!

There will be a live webcast, but that probably will not be archived. I’m thinking, therefore, of buying a digital webcam that can store up to 24 hours of hi-res video and a tripod so I can set up my video recording shop in the second row. Some trade press jerk in the 3rd row, however, is likely to make a fuss and complain that the camera is obstructing his view! In case that happens and I can't use the video camera, I’ll record the audio with my handy SANSA MP3 player/recorder.

Instead of bringing all that AV equipment, I was thinking of switching to AT&T wireless and getting an iPhone because it can record up to 1 hour of video and I would be able to upload it immediately to YouTube. But that would mean I would have to run out of the room like Cary Grant to “file” my Youtube story in the middle of L’Enfant Plaza where presumably there’s a WI-FI hotspot. I would probably lose my seat though. Besides, the iPhone has a lousy mic. The new Verizon "there's a map for that" ad ultimately convinced me to wait until I can get an iPhone on the Verizon network.

On one of my many calls to Jean-Ah Kang, I learned that only a few people were asking to make a presentation. I immediately volunteered to give a presentation summarizing the results of the survey I created on September 20 (see here). I submitted a request as specified by the FDA on September 30, 2009 (see http://bit.ly/JNsu4).

Jean-Ah assured me that I will be on the agenda, but I hope I don't get bumped to make room for a speaker from Pharmaceutical Executive Mag. I don't think that will happen, though. PE doesn't make the news, it only reports it. I, on the other hand, have lead the fight for this public hearing (see "FDA, Tear Down This Wall! A Draft Petition Calling for a Public Hearing") and that has become part of the news.

So I’m all set and ready for my repeat performance. Well, not exactly a repeat. I was a speaker at the 1996 public hearing (see “FDA and Internet”), but did not get 15-20 minutes solo time to speak and present slides as I will do this time.

This time, I predict a different outcome; namely, the FDA will publish some form of draft guidance before the end of 2010. This guidance may clarify only one of the many issues that concern pharmaceutical marketers. It may, for example, just deal with providing fair balance when space is limited – as in Google Adwords – or it may concern monitoring and reporting adverse events on social media sites. I am hoping it’s the latter, because I am very tired of hearing pharma marketers complain how FDA’s AE reporting requirements are hobbling their use of social media. FDA should do something about that so I won’t have to hear that excuse again!

Whatever the outcome, there’s sure to be fear expressed during the meeting and a lot to loathe about the snail’s pace of change afterward. Just watch out for those bats!

Thursday, October 22, 2009

Pharma Social Media Crips vs. Legal/Regulatory Bloods: Call for a "Peace" Conference

After a short vacation in the Blue Ridge Mountains of Shenandoah National Park (see my photos on Flickr here), I was feeling disconnected from my homies in the pharma marketing social media hood. So, yesterday, I got in my whip and went cruising for ExL Pharma's 3rd Annual Digital Pharma "un" conference in Bridgewater, NJ.


All the members of my posse were there including Fabio Gratton (@skypen), Brad Pendergraph (@bradatpharma, who I predict may not long be "at pharma"), Kevin Nalty (aka "Nalts"; @nalts, no longer at pharma), Shwen Gwee (@shwen, currently at pharma), Steve Woodruff (@swoodruff, who took the photo on left; that's me in the yellow Hawaiian shirt that Steve did not like), Ellen Hoenig Carlson (@ellenhoenig), Christiane Truelove (@Christinaetrue), Phil Baumann (@philbaumann), Jonathan Richman (@jonmrich), and other members of the pharma social media posse. Search for the #digpharm Twitter hashtag (see here) to find them all.

What you won't find, however, are any pharma legal/regulatory folk. At yesterday's "un" conference afternoon session there was a lot of complaints about legal/regulatory restrictions on the use of social media by pharma marketers. You know, "legal/regulatory won't allow us to do this" and "legal/regulatory won't allow us to do that" and "our legal/regulatory people don't understand social media," etc., etc.

When I asked "Are they any legal/regulatory people here?", no one raised their hands. Maybe they were there but afraid to expose themselves to such a hostile group or -- much more likely -- they just were not there.

The disconnect between legal/regulatory within pharma and social media advocates inside and outside pharma has gotten so bad, I liken the situation to street gangs (eg, Crips vs. Bloods)

Unless these two pharma gangs can discuss and resolve their differences (ie, by sending representatives to a social media "peace" conference), we're not making any progress. And I don't think any guidance from the FDA will make a bit of difference (more about that in my next post).

Wednesday, October 21, 2009

Snowy Skyland Resort


Click Here for More Images
Originally uploaded by John Mack
I spent the last few days in Washington, DC and on Skyline Drive in the Shenandoah National Park, VA. Here's What it looked like from the front door of our room at the Skyland Resort on the first day - Oct 19, 2009.

Sunday, October 18, 2009

I Will Present Survey Results at November FDA Hearing

I just received confirmation from Jean-Ah Kang, Special Assistant to Tom Abrams at DDMAC in charge of Web 2.0 policy development, that I will be presenting the results of the survey "FDA's Regulation of Drug & Device Promotion via the Internet & Social Media" at the November 12-13, 2009 public hearing in Washington, D.C.

To date, there have been over 250 responses to this survey. My goal is to have at least 350 responses by November. So, if you have not already taken the survey -- which seeks opinions on the 5 topics of interest to the FDA -- please do it now to get your opinion counted. Of course, you can also submit your comments directly to the FDA, but the survey is the only known instrument that allows a quantitative evaluation of specific solutions that address FDA's concerns.

To respond to the survey right now, click here.

Thursday, October 15, 2009

No Schering-Plough Ice Cream for You, MA VT MN Doctors!

The pharmaceutical industry doesn't like "sunshine" laws passed in some states that either forbid or put limits on gifts to physicians. In a bid to prevent these laws from passing, the industry made threats to pick up their dollar bills and play in other states; eg, not run clinical trials in Massachusetts or not have booths at medical meetings in Vermont. As if!

Some might call it blackmail, others call it good business practice. Whatever. The ploy didn't work and Massachusetts, Vermont, and Minnesota passed their laws anyway. And drug companies still run clinical trials and have booths at medical meetings in those states, which are renowned for their medical clinics and/or meeting venues (MA: All sorts of great medical centers; MN: Mayo Clinic; Vermont: skiing; say no more, a nod's as good as a wink to a blind bat!).

If you can't live without those states, you'll just have to live with them. But you don't have to take it lying down is how Schering-Plough views it. That company has denied MA, VT, and MN doctors a scoop of ice cream on a cool autumn afternoon in Boston! Dude, that's rad! Here's a sign seen at the ACEP Scientific Assembly in Boston (Hat tip to Whitecoat):



According to Whitecoat, "The legal picture of the day was at an ice cream stand. Sorry you docs in Minnesota, Vermont, or Massachusetts. Either your butts are too fat or there is some legal decision stating that ice cream cones may unduly influence your decision to prescribe medications."

I'm not going to get into how big some docs' butts might be or how silly VT's sunshine law may be, but it is inconceivable that free ice cream at a medical convention in Boston would rile VT prosecutors enough to send undercover VT docs to the meeting in order to catch SCP in the act of giving away free ice cream!

What is silly, however, is SCP putting up this sign in an obvious (to me) attempt to rile VT, MA, and MN physicians, hoping they will go back home and complain to their lawmakers how they were denied a scoop of ice cream!

I'm sure all the MA, MN, and VT docs had a good laugh as they strode in to the exhibit for their just desserts!

Wednesday, October 14, 2009

Boehringer's Branded Tweet Violates FDA Regulations Just Like Those 14 Paid Search Ads Did

Today marks another first for pharma's foray into the murky world of social media marketing. Boehringer-Ingelheim (BI), the German pharma company, just posted the following branded Tweet via Twitter:



The link in that Tweet leads to this press release, which provides the details, including fair balance (eg, side effects).

The press release also states:
Please be advised
This release is from Boehringer Ingelheim Corporate Headquarters in Germany. Please be aware that there may be national differences between countries regarding specific medical information, including licensed uses. Please take account of this when referring to the information provided in this document. This press release is not intended for distribution within the U.S.A.
About two-thirds of my Twitter followers are based in the US. According to this source, 62% of ALL Twitter users are US based. Therefore, it is difficult for me to imagine that BI did NOT intend this Tweet to be distributed within the U.S.A.

So there's THAT criticism of this Tweet. I also criticize it for violating FDA regulations (and maybe ABPI guidelines as well).

BI's branded tweet goes one better -- or worse, depending on your viewpoint -- than Novo Nordisk's Levemir branded Tweet (see Novo Nordisk's Branded (Levemir) Tweet is Sleazy Twitter Spam!). Namely, it mentions BOTH the product name AND the indication without including within it the fair balance. It is, therefore, very similar to the paid search ads that the FDA said violated the law (see "FDA's Actions Speak Louder than Its Words: On the Internet It's the Medium as Well as the Message!").

Up until now, BI has been very careful to avoid this sort of thing in its Tweets. I wonder if this was some kind of oversight, because it doesn't make much sense to issue such a branded Tweet in the USA or anywhere else.

For more about BI's social media strategy, listen to this podcast in which I interview Judith von Gordon and John Pugh, external communications executives at Boehringer Ingelheim ("Pharma on Twitter: Boehringer Ingelheim").

Tuesday, October 13, 2009

CEI's Critique of FDA's Paid Search Stance Should be Titled "The Little (Search) Engine that Could"

"Hey, John. This is America, after all, and everyone is entitled to their opinion—even you!," said Arnie Friede, co-author the Competitive Enterprise Institute's (CEI's) article "FDA and Advertising" (see here), in an e-mail to me. He was responding to my blog post in which I called CEI's premise --ie, "FDA's position on sponsored links could have the unintended effect of making regulated information less available to consumers while making less reliable and unsubstantiated information more available...If sponsored links for highly regulated drugs and devices become more rare, then an information seeker will be relegated to wading through a list of Web sites that contain all manner of information of dubious validity." -- "Carefully Wrought Bullshit" (see "Is FDA's Sponsored Search Advertising Policy Increasing Consumer Risk?")
"For my part," continued Friede, "the CEI paper was not offered or characterized as empirical evidence on any point. The language was carefully chosen to say that FDA’s policy “could have” the unintended effect postulated. The matter certainly deserves careful consideration and study. I would submit that your quick look at Google probably does not qualify as such an analysis. As for doing a disservice to FDA, I think that raising important arguments like these for consideration by everyone affirmatively serves FDA’s interests in having all of the arguments on all sides vetted. That is the essence of transparency."
Since Friede cites transparency, I would like to reveal the communications I have been having with the authors of this report, who have chosen not to respond in comments to my blog.

Greg Conko, the other co-author of the CEI report, also emailed me. "I was tempted to let Arnie's reply speak on my behalf as well," said Conko. "But I thought it was worth repeating Arnie's point that we, in our paper, suggest only that a diminution in paid links by pharma companies 'could' result in raising the visibility of links for unregulated products, most of which are of unknown or dubious quality. It's a simple proposition: In a world characterized by A and B, a smaller number of A without a change in the number of B implies a higher proportion of B."

Conko continues:
You twice accurately quote us as claiming this 'could' occur, but then you misleadingly write that we "claim that the void has been filled by ads of 'dubious validity'," and allege to have knocked down this strawman. The questionable validity of your test results aside, you'd think that someone who so glibly uses such phrases as "carefully wrought bullshit" and "complete disregard for facts" might be a little more careful with his own arguments.

It is, of course, your prerogative to suggest that what we wrote is unlikely, or that you are confident upon further examination it will prove to be untrue. I, however, suspect that, upon further examination, we will find a proportionately larger number of links for unregulated products as for regulated ones.
Freide ended his email in a similar vien:
As for characterization that what we have written is “Carefully Wrought BS”, both Greg and I are lawyers and, at least as to me, it is not the first time, nor will it likely be the last time, that someone has called what I have said “BS”. I am prepared to be judged on the merits of the analysis, including the analysis in CEI’s recent comments to FDA and the attached article of mine from FDLI Update titled, “Yes We Can: Time for an FDA Drug Advertising Policy”
It appears that Friede speaks for Conko and vice versa.

Unlike lawyers, my goal is not to argue in order to win my case. At least I offered evidence -- albeit flawed -- that Friede and Conko's premise was false (in a real court, I "could" win if the jury saw my "evidence" even if it had no scientific merit. Unlike the FDA, juries and the public in general are not swayed so much by science as they are by carefully wrought BS). More importantly, however, is my challenge to everyone out there to provide BETTER evidence that CEI's premise is true. Only with such evidence will the FDA be swayed to change its opinion.

It is not within my capability to provide the needed evidence. Friede & Conko should have done that instead of imagining what "could" happen. Many things can happen if suddenly there were no more pharma paid search advertising. Google stock shares "could" lose 30% of their value! Maybe I should write a report claiming that "could" happen and short sell Google! Now there's an idea worth pursuing.

Saturday, October 10, 2009

Are There Special Cases for Correcting Misinformation on Social Media Sites?

In preparation for FDA's public hearing on the Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools, the agency is asking for comments on 19 specific questions (see "Let's Respond to FDA's Questions Regarding Its Regulation of Social Media"). These questions are included in my ongong online survey/questionnaire, which you can access here.

I am following the results of this survey closely and will provide updates. Here, I focus on this question:
Should the parameters differentiate with regard to the prominence of the third-party site (i.e., readership), its intended audience (e.g., general public, health care professionals, patients), its intended purpose (e.g., personal diary, encyclopedia-type reference), and/or the author of the information on the site?
The survey asks respondents to choose only one of the following responses (and add additional comments):
  • Yes
  • No
  • No Opinion
  • NA (no parameters are required)
The image below shows how respondents answered this question (ALL respondents vs. PHARMA respondents). The image will be updated frequently. See the date stamp on the image for when it was last updated. To see the most up-to-date results, please take the survey yourself and you will be able to see a summary at the end.
Special Case for Corrections

Many comments were submitted in response to this question. Some of these comments include:
  • With the caveat that if the general public can access a site, even if it is intended for physicians, it should adhere to regulations for general public regulations.
  • Only in that the "best efforts" criterion should only reasonably apply to sites that are on the first page of a Google search, or similar criteria ie. general public likely to find that information easily.
  • It's the responsibility of the content provider to make their audience aware of who they are representing. It is the responsibility of the viewer to ask in a social environment.
  • It's finding the balance between few/broad categories to avoid too much red tape and complication and one rule for all, which would detrimentally limit significant groups and not be helpful to public health.
    Prominence and author shouldn't matter, but the intended audience and purpose are relevant.
  • Yes, but as I have explained before pharma companies should not assume a role of watchdog.
  • Health care professionals should have the correct information as determined by consensus and should be reminded to not misrepresent the information. They have more influence if it is known that they are professionals so they can cause greater damage from misinformation. Some people calling themselves health professionals are misrepresenting their real qualifications. Again, as an example, the scienceblogs will review the qualifications of an individual calling themselves a "health expert" while also commenting on the distortions of the information.
  • Essential to distinguish between the general public and health care professionals!
  • Companies likely to automatically 'correct' entries in more critical/visible places without regulation
  • Third-party sites with higher readership, geared to general public, and/or encyclopedic in nature should carry greater weight in companies acting on correcting information.
  • if information is wrong it should be corrected in all circumstances that the company is aware of
WANTED: Answers to FDA's Questions Regarding Pharma's Use of Social Media
SPECIAL REPORT: FDA Regulation of Social Media

Find links to more preliminary results here.

Friday, October 09, 2009

How Should Pharma Companies Submit Social Media Content for FDA Approval?

In preparation for FDA's public hearing on the Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools, the agency is asking for comments on 19 specific questions (see "Let's Respond to FDA's Questions Regarding Its Regulation of Social Media"). These questions are included in my ongong online survey/questionnaire, which you can access here.

I am following the results of this survey closely and will provide updates. Here, I focus on this question:
How should companies address the potential volume of information shared on various social media sites with regard to real-time information that is continuously posted and regulatory requirements to submit promotional materials to FDA as applicable.
The survey asks respondents to choose one or more of the following responses (and add additional comments):
  • FDA Should Audit Social Media sites on regular basis -- eg, yearly (requires mandatory registration of sites with FDA)
  • Drug company should submit only content that it is responsible for (ie, created directly or paid a 3rd party to create) as soon as that content is posted (no submission of non-company content)
  • Drug company should submit only content that that it creates (ie, created directly or paid a 3rd party to create) upon first use of social media site, then periodic -- eg, monthly -- submissions afterward (no submission of non-company content)
  • Submit Social Media Site 'template' (design and/or sample content) to FDA for pre-approval/approval.
  • Something Else (submit your idea in next question)
  • Can't Be Done
  • Don't Know
The image below shows how respondents answered this question (ALL respondents vs. PHARMA respondents). The image will be updated frequently. See the date stamp on the image for when it was last updated. To see the most up-to-date results, please take the survey yourself and you will be able to see a summary at the end.
How to Submit SM Content for FDA Approval

Many comments were submitted in response to this question. Some of these comments include:
  • Content not directly influenced by the company should not require submission to the FDA. Only content directly developed or paid for by the company should be submitted.
  • create a definition of a "representative sample" of information shared on various social media sites. this can be submitted on a regular (monthly, quarterly) basis. In addition to this, FDA could conduct yearly audits.
  • They should make a good faith effort to submit what is authored by them and paid for by them
  • develop templates and get pre approval for FDA
  • Information will be initially screened through a social media contact of each company or division (as deemed by medical organizations) and aggregated each week to be filtered through the regulatory process as necessary. Social media contacts will need to be well-versed on company policies and FDA regulations to sufficiently pre-screen comments and real-time conversations. After internal regulation is complete, companies that are generally responsible for responding to the FDA should submit materials through the web on a bi-weekly basis.
  • I think the point should not be to control all the volume of information but to provide official channels for the patients and/or health care professionals to report any relevant information.
  • FDA should set up a social media information repository that reviews material solely used for social media on a different timeline than traditional content.
    one common reporting service - required by law to be integrated per the Schroeder Plan
  • Companies should be held accountable for ensuring systems are in place to regularly monitor/review information from social media sites. However, the concept that such information be considered 'spontaneously' reported and de facto 'related' and subject to collection and reporting rules needs to be revisted. Also in some cases, the concept of an 'identifiable' reporter is questionable, as is the opportunity for follow-up and obtaining meaningful information. Monitoring such information should be considered part of active/pro-active surveilance, but not subject to standard safety processing.
  • If the company has no part in creating the environment or content, the company should not be held accountable for submitting. If the company creates the environment, appropriate disclaimers regarding the source of the postings should be prominent and submission for postings made by non company contributors with no payment should not be required. Any comments posted by company or paid for by company should be submitted with appropriate DOFU.
  • That's a great question, and one for which I do not have the answer. The major limitation of the internet is that anyone can say anything at any time about a product/company. Who's to say it isn't going to be cases of corporate sabotage?
    Companies should submit any promotional content that is not interactive (e.g. an initial blog post) at first use. Companies should then send scheduled updates (monthly?) with interactive content (e.g. Responses to comments posted on the site). Alternatively, each company could send the FDA information (including email addresses, the sites where they are authorized to post items, and their user names on those sites) enabling the agency to monitor information in real time.
  • If sponsored by the company - then they need to address and monitor. If user generated then should not be mandated.
    Pharma shouldn't promote the product and instead add value to patient by giving help and care
  • Whoever can answer that will be able to start a thriving consulting business
WANTED: Answers to FDA's Questions Regarding Pharma's Use of Social Media
SPECIAL REPORT: FDA Regulation of Social Media

Find links to more preliminary results here.

Should Pharma Companies Correct Drug Misinformation Posted on 3rd-Party Social Media Sites?

In preparation for FDA's public hearing on the Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools, the agency is asking for comments on 19 specific questions (see "Let's Respond to FDA's Questions Regarding Its Regulation of Social Media"). These questions are included in my ongong online survey/questionnaire, which you can access here.

I am following the results of this survey closely and will provide updates. Here, I focus on this question:
Are there any parameters or criteria that could be used to determine the appropriateness of correcting misinformation and/or scope of information a company can provide when trying to correct misinformation on a Web site outside a company's control?
The survey asks respondents to choose one or more of the following responses (and add additional comments):
  • ONLY misinformation of real and imminent danger to the public health (to be determined by company) should be corrected
  • ALL off-label claims -- even if supported by peer-reviewed medical literature -- should be corrected
  • Only off-label claims NOT substantiated by peer-reviewed medical literature should be corrected
  • Companies should not be burdened by FDA regulations requiring them to make corrections about ANY product misinformation published on third-party sites
  • None of the above
The image below shows how respondents answered this question (ALL respondents vs. PHARMA respondents). The image will be updated frequently. See the date stamp on the image for when it was last updated. To see the most up-to-date results, please take the survey yourself and you will be able to see a summary at the end.
When to Correct 3rd Party Drug Misinformation

Many comments were submitted in response to this question. Some of these comments include:
  • It is in the company's best interest to correct misinformation but this cannot practically be done in all cases. Too much of a burden to monitor.
  • One issue is that manufacturers will have this burden and generic manufacturers will not
  • Companies should be permitted to update third-party sites to correct misinformation but not held responsible if subsequent changes re-introduce misinformation.
  • Would be nice to correct all the published misinformation on pharmaceutical or health care products... I think it is impossible to find all of them
  • Guidance should be given on how companies can navigate this area but it should not be mandatory.
  • Who would decide what is of real or imminent danger? Regarding off-label claims supported by peer review, Medicare and many insurance companies accept this info for funding many new drugs, particularly in oncology, so why should a company try to correct this. Finally, it would be difficult for a company to know of all the potential off-label claims and uses that occur every day, several of which occur when drugs are used in combination therapy and it is another drug that is being used off-label, thus making both products' use off-label. As well, there is every time a different dose is used based on the treating physician's judgement. It would be impossible to monitor this, let alone take corrective action.
  • If you watch what happens when misinformation is posted you'll see social media channels are quick to highlight misinformation and mistakes. A company or person that puts out misinformation on a regular bases will be dropped by the participants in the network.
  • social media should not be considered different from other platforms. Do companies perform corrective action if on their way to work, they pass by a billboard paid for by a third party containing erroneous information about one of their brands? No. They may ignore it, counter it, or litigate it, but almost certainly not take corrective action against it.
  • Guidance in this area is needed, and some flexibility based on multiple factors/considerations - including clinical relevance, public health impact, and impact of the misinformation
  • off-label use of a product isn't necessarily bad (e.g. Byetta with TZD at launch was off-label though clinical data was in front of the FDA for the indication). This kind of discussion takes place ALL the time when one HCP solicits the information from another. Who is to define imminent danger? What may be a huge ordeal to one person may not be to another. It seems like a very slippery slope.
  • In my opinion pharma companies should have the freedom to correct, but not the responsibility to act as a watchdog. Otherwise that would be an unbearable burden.
    If the company is not affiliated with the site in any way, they should not be responsible for the content put out by that site.
  • They should constantly educate the public that their own website has the appropriate information and comment on their website about inaccuracies seen throughout the web.
  • Companies should contribute post approval money to a watchdog government agency that at least reports on Internet misinformation.
  • Because of the evolving nature of social media, it would be unrealistic to require companies to monitor and correct misinformation across all social media vehicles. Instead, a standardized approach should be formulated that could be applicable across several types of social media vehicles. the viewer of the information would need to somehow be assured that the communication was coming from a legitimate (company) source, and therefore could be trusted as accurate. If these parameters (at a minimum) could be met, then the manufacturer should retain the right to correct misinformation as they see fit in whichever social media vehicle they choose.
WANTED: Answers to FDA's Questions Regarding Pharma's Use of Social Media
SPECIAL REPORT: FDA Regulation of Social Media

Find links to more preliminary results here.

Thursday, October 08, 2009

Is FDA's Sponsored Search Advertising Policy Increasing Consumer Risk?

A new Competitive Enterprise Institute (CEI) analysis cautions that FDA’s current policy restricting use of Internet sponsored links could have the unintended effect of making regulated information less available to consumers and making less reliable and unsubstantiated information more available.

CEI's report, entitled "DDMAC's Internet Stance Could Increase Consumer Risk," contends that "FDA's position on sponsored links could have the unintended effect of making regulated information less available to consumers while making less reliable and unsubstantiated information more available...If sponsored links for highly regulated drugs and devices become more rare," says CEI, "then an information seeker will be relegated to wading through a list of Web sites that contain all manner of information of dubious validity."

Indeed, sponsored links for regulated drugs HAS become more rare (see "FDA Letters Caused a Prompt, Precipitous, & Prolonged Drop in Pharma Paid Search Engine Advertising").

But CEI's claim that the void has been filled by ads of "dubious validity" is unsubstantiated by any PROOF whatsoever. In fact, it is an example of "Carefully Wrought Bullshit" (see "Is Pharmaceutical Marketing BS?") that displays a complete disregard for facts.

I did a little experiment to test CEI's hypothesis. I searched Google for "enlarged prostate medication." Below is the screen shot of the results. I checked out each of the results -- both the paid links and the natural search results and labeled them in the following image (click for an enlarged view).



Four of 13 paid ads (31%) were for FDA regulated products. In fact, 100% of the paid ads at the top of the page are for such products. There are 4 ads of a "dubious" nature and 1 for a physician hawking his services (not sure if that is dubious or not. CEI says that physicians are "learned intermediaries" that protect consumers from any harm DTC advertising might cause.)

All the natural search results refer to trusted health websites that carry seals of approval or for a major newspaper (NY Times).

I have done similar searches before and have gotten the same results. The vast majority of paid and unpaid search results (72% in this case) will lead consumers to trusted and/or FDA-regulated health information.

CEI should not try and scare people by implying that FDA's policies are harming public health!

P.S. Some of my colleagues are offering proof that when major Rx brands stopped advertising on Google, competitors -- including those of a dubious nature -- took up the slack as far as paid links are concerned. They use tools such as SpyFu, which is an "online competitive intelligence application that allows you to browse competitors' PPC [pay per click; eg, Google Adwords] keywords, daily budget, bid prices, clicks/day, and other interesting PPC facts & figures" (see here). Using this tool you notice that when Rx ads are AWOL, you get competitor ads. That's to be expected -- this is a capitalistic, competitive society folks! When it comes to commercialism -- dubious or not -- it is always BUYER BEWARE online and OFF! Also, don't forget that you still have natural, unpaid search results, which 75% of the time will lead consumers to reputable sources of health information online.

Another point about CEI's report is that it sounds more like an anti-FDA screed than a rationale argument, which is something that won't sit well with FDA folks. Accusing the FDA of harming the public health without any basis in fact is a slap in the face to many public servants who make considerably less income than the authors of the CEI report. Many within the FDA believe fervently in their mission to protect the public health and I can't imagine them being very happy with CEI's accusation.

Pharma Companies Should Have Public Social Media Disclosure Policies, Survey Results Show

In preparation for FDA's public hearing on the Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools, the agency is asking for comments on 19 specific questions (see "Let's Respond to FDA's Questions Regarding Its Regulation of Social Media"). These questions are included in my ongong online survey/questionnaire, which you can access here.

I am following the results of this survey closely and will provide updates. Here, I focus on this question:
How should companies disclose their involvement or influence over discussions or material, particularly discussions or material on third-party sites?
The survey asks respondents to choose one or more of the following responses (and add additional comments):
  • Disclosure is necessary only when content is paid for.
  • Disclosure should be prominently displayed alongside relevant content when possible
  • Disclosure and disclaimers should be included prominently on the corporate website near any links to social media outlets.
  • Each company should have a public SM policy that includes a notice of its transparency policies.
  • None of the above
The image below shows how respondents answered this question (ALL respondents vs. PHARMA respondents). The image will be updated frequently. See the date stamp on the image for when it was last updated. To see the most up-to-date results, please take the survey yourself and you will be able to see a summary at the end.
Disclosure of 3rd Party Content Involvement

Many comments were submitted in response to this question. Some of these comments include:
  • We can't make rules/laws for everything. It would be better to hold companies responsible to their stakeholders - investors, customers, patients, healthcare professionals, etc etc.
  • Disclosure and disclaimers should be included prominently on the corporate website near any links to social media outlets.
  • When companies pay for content to be produced on their behalf, a disclosure, disclaimer and list of policies should be included prominently on the corporate and associated websites near any links to social media outlets.
  • A notice of disclaimer should be provided whenever there is a content favorable to the company's interests that has been elaborated directly or indirectly by any third-party benefited by the company.
  • Disclosure must be constant, no exceptions; even Twitter comments must contain disclosure, even if in the form of a hashtag (#iwork@novartis is in use today)
  • If true: "We encourage our employees to message about their experiences with our products, but they are not separately compensated for these messages. You should consider whether opinions being offered here are from a source whose employment is tied to the maker of the product being discussed."
  • If company involved, should always disclose. In scenario where a brand has sponsored some activity, could disclose pharma company involvement without mentioning the brand name, not as a way to cover up brand involvement but to avoid using brand name and triggering need for fair balance.
WANTED: Answers to FDA's Questions Regarding Pharma's Use of Social Media
SPECIAL REPORT: FDA Regulation of Social Media

Find links to more preliminary results here.

Regulatory Solutions to Overcoming Space Limitations in Pharma Social Media Communications

In preparation for FDA's public hearing on the Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools, the agency is asking for comments on 19 specific questions (see "Let's Respond to FDA's Questions Regarding Its Regulation of Social Media"). These questions are included in my ongong online survey/questionnaire, which you can access here.

I am following the results of this survey closely and will provide updates. Here, I focus on this question:
Are there proposed solutions that may help address regulatory concerns when using social media tools associated with space limitations or tools that allow for real-time communications to present product information?
NOTE: FDA has "regulatory concerns" primarily about over emphasis of benefits and/or under emphasis of risks in Rx drug communications by pharmacos.

The survey asks respondents to choose ONLY one of the following responses (and add additional comments):
  • Yes
  • No
  • Don't Know
The image below shows how respondents answered this question (ALL respondents vs. PHARMA respondents vs. Agency respondents). The image will be updated frequently. See the date stamp on the image for when it was last updated. To see the most up-to-date results, please take the survey yourself and you will be able to see a summary at the end.

Regulatory Solutions to Overcoming Space Limitations in Pharma SM Communications

Several comments were submitted in response to this question. Some of these comments include:
  • The government cannot control communication - see the Bill of Rights
  • Very flexible dynamic display or previews of content are possible through most browsers (considering the 2 most recent versions). These provide 1 click access while not navigating a user away from the original content.
  • Terms of Use prominently displayed which would include manufacturers guidelines on information
  • Mouse-overs to especially call out need to investigate balanced content seems to be a viable alternative.
  • Include short URL to safety information: one click away
  • Web page banners that provide links to company and government information related to and useful for understanding the topic under discussion.
  • I have crafted a set of instructions to address typical FDA regulation and to answer internal regulatory bodies on time and content constraints, though I am not aware of any other companies proposed solutions.
  • Companies should have a policy concerning this usage and be responsible for any social media that they or their employees/contractors utilize.
  • Technology solutions exist, but don't know if they have been proposed.
  • Phone line indicated in any communication
  • Understand in case of microblogging space is limited - disclosures could be on "linked" page.
  • People should understand that it's Twitter... it's not exactly an exhaustive resource. Links to the reliable information should be sufficient.
  • I haven't seen any proposed solutions. This quiz presents some, such as the one- or two-click rule for disclosure.
  • pop ups
  • The rule is straightforward. If you present benefits, you must present risks. If the platform is insufficient to present both, alter your tactical use of the platform (i.e. use it as a driver for direct response, make it unbranded, etc.)
  • BAn paid Tweets for FDA licensed drug promotional efforts.
  • The link to web site information solution noted above

WANTED: Answers to FDA's Questions Regarding Pharma's Use of Social Media
SPECIAL REPORT: FDA Regulation of Social Media

Find links to more preliminary results here.

Wednesday, October 07, 2009

Does Social Media Have an Impact on Public Health? FDA Wants to Know.

In preparation for FDA's public hearing on the Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools, the agency is asking for comments on 19 specific questions (see "Let's Respond to FDA's Questions Regarding Its Regulation of Social Media"). These questions are included in my ongong online survey/questionnaire, which you can access here.

I am following the results of this survey closely and will provide updates. Here, I focus on this question:
Are there data to support conclusions about whether different types or formats of presentations have a positive or negative impact on the public health?
NOTE: The FDA may be interested in other "formats" or "presentations" than those available through online social media (see comments below).

The survey asks respondents to choose ONLY one of the following responses (and add additional comments):
  • Yes
  • No
  • Don't Know
The image below shows how respondents answered this question (ALL respondents vs. PHARMA respondents vs. Agency respondents). The image will be updated frequently. See the date stamp on the image for when it was last updated. To see the most up-to-date results, please take the survey yourself and you will be able to see a summary at the end.

SM Impact on Public Health

Several comments were submitted in response to this question. Some of these comments include:
  • I am not aware of any studies that have related exposure to promotional messages to effects on outcome. On the other hand, there is a growing body of evidence to show that most pharma company efforts to enhance adherence and compliance to their medications have been less than successful
  • I don't know the data, but I believe that for many people, reading the package insert is daunting. I have no option to suggest that would meet regulatory requirements outside of IM or chat, which would be very resource intensive.
  • Veracity of the content (based on the authenticity of the author) almost invariably has a positive impact on health.
  • Multiple studies have been done to show the effectiveness of various fair balance presentations
  • Data not available at this time because so few are using the internet for fear of FDA sanctions.
  • I have not come across any data suggesting such in my research, however I imagine informational theories will surface soon. Other topics for discussion may be the possibility for the public to over or under react to health issues based on information they read, or for the uncommon candidate to self-diagnose, which could potentially lead to misguidance on medical education.
  • I don't know the data but I am aware of a lot of misinformation about medical products such as vaccines. I would like to see better feedback mechanisms from non-biased third parties to allow for better correction of memeplexes that have little relationship to reality and have important public health ramifications.
  • Scienceblogs does a good job of commenting on the inappropriate medical/science reporting on the HuffingtonPost website. This process might be formalized somewhat on a "RealityPedia" that people could easily link to for a summary of vetted information.
  • Please make decisions that are driven by data and by common sense!
  • Utilization of Drug Facts Boxes
  • After extensive research about social media, I have not come across any data to confirm the impact of social media on public health

WANTED: Answers to FDA's Questions Regarding Pharma's Use of Social Media
SPECIAL REPORT: FDA Regulation of Social Media

Find links to more preliminary results here.

Tuesday, October 06, 2009

Pharma Prefers "1-Click Rule" for Presenting Fair Balance in Social Media & Other Internet-based Rx Ads

In preparation for FDA's public hearing on the Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools, the agency is asking for comments on 19 specific questions (see "Let's Respond to FDA's Questions Regarding Its Regulation of Social Media"). These questions are included in my ongong online survey/questionnaire, which you can access here.

I am following the results of this survey closely and will provide updates. Here, I focus on this question:
How should product information be presented using various social media tools to ensure that the user has access to a balanced presentation of both risks and benefits of medical products?
The survey asks respondents to choose ONLY one of the following responses (and add additional comments):
  • No matter the media, all product ads should include major risk information along with benefits (media agnostic)
  • When it is not possible to include major risk information due to space limitations, it is sufficient to include a link to the product Web site where consumers can then find all the necessary risk information in the package insert (2-click rule)
  • When it is not possible to include major risk information due to space limitations, it is sufficient to include a link directly to the package insert (1-click rule)
  • None of the above
For background on the "1-click rule," see the following:
The image below shows how respondents answered this question (ALL respondents vs. PHARMA respondents vs. Agnecy respondents). The image will be updated frequently. See the date stamp on the image for when it was last updated. To see the most up-to-date results, please take the survey yourself and you will be able to see a summary at the end.

Fair Balance Presentation

Several comments were submitted in response to this question. Some of these comments include:
  • Ads should carry a disclosure of interest and warning about risks with a 1 click route to package insert
  • Magazine advertisements, largely seen as the gold standard, require a page turn to review fair balance; a 1-click rule is a logical analog for the online world, and online ads must not be held to an unfair standard
  • More than worry about providing risk/benefit info, FDA should worry about how to make this info more accessible/comprehensible to patients. Social media could be a great way to achieve this by providing patients a means to ask questions and by offering a much more comprehensive (visual, audio, video, graphs etc.) to share and communicate this important information.
  • The majority of the public does not know that PIs exist let alone how to read them. Taking them to a company website allows for too much bouncing vs. immediate redirect to Patient PI
  • Nevertheless it should be sufficient that FDA maintains an online database with all the package inserts accessible for any user at any time.
  • The risks must be written in regular English and easily understood. Should have an initial summary as many people skim pages quickly.
  • Paid Tweets seem out-of-bounds, to my experienced eye.
  • in my experience, it takes a lot of space/characters to fully and fairly disclose all the risks/benefits, and it seems that if the user can get to it within two clicks that should be sufficient
  • As may already be the case, abbreviated product inserts should be available (1-click rule) at "8th grade" reader level, focusing on the key risks and benefits of the drug or device. Also, updates of these information documents should be frequent and immediate if serious adverse events are verified.
  • The one click should go to page which has package insert, but also synopsis of PI with major risk/benefit highlighted. PIs can be daunting for patients to navigate through.
  • Another potential option is to link to a manufacturer-sponsored microsite that has been specifically designed to fit social media fair balance needs. In some situations, this could be customized to provide contextual fair balance to correspond to the topic being discussed in the social media vehicle. (eg. a discussion board comparing side effects between products links to a microsite that provides all approved messaging regarding comparative data, along with a disclaimer that any other claims or data has not been reviewed or approved by the FDA)
  • I'm a 2-click rule advocate with easy-to-find access to PI.
  • A 1 click rule where the user lands on a 'landing page' that includes the PERTINENT fair balance info would be good too. This would be user-friendly (since it's not the entire PI) and also very informative (since it pertains to the parent content).

WANTED: Answers to FDA's Questions Regarding Pharma's Use of Social Media
SPECIAL REPORT: FDA Regulation of Social Media

Also see:

Monday, October 05, 2009

3rd Party Dissemination of Altered Rx Drug Information on Social Media Sites. Survey says...

In preparation for FDA's public hearing on the Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools, the agency is asking for comments on 19 specific questions (see "Let's Respond to FDA's Questions Regarding Its Regulation of Social Media"). These questions are included in my ongong online survey/questionnaire, which you can access here.

I am following the results of this survey closely and will provide updates. Here, I focus on this question:
With regard to the potential for company communications to be altered by third parties, what is the experience to date with respect to the unauthorized dissemination of modified product information (originally created by a company) by noncompany users of the Internet?
The survey asks respondents to choose one or more of the following responses (and/or add additional comments):
  • Unauthorized product information pages in Wikipedia
  • Unauthorized product Twitter accounts
  • Unauthorized product Blogs
  • Unauthorized communications in discussion boards
  • Unauthorized Google Sidewiki comments on drug.com sites
  • None of the above
The image below shows how respondents answered this question (ALL respondents vs. PHARMA respondents vs. Agency respondents). The image will be updated frequently. See the date stamp on the image for when it was last updated. To see the most up-to-date results, please take the survey yourself and you will be able to see a summary at the end.

Unauthorized third-party content


WANTED: Answers to FDA's Questions Regarding Pharma's Use of Social Media
SPECIAL REPORT: FDA Regulation of Social Media

Also see:

Sunday, October 04, 2009

Should FDA Regulation Depend on Specific Media or Audiences? Survey says...

In preparation for FDA's public hearing on the Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools, the agency is asking for comments on 19 specific questions (see "Let's Respond to FDA's Questions Regarding Its Regulation of Social Media"). These questions are included in my ongong online survey/questionnaire, which you can access here.

I am following the results of this survey closely and will provide updates. Here, I focus on this question:
Are there different considerations that should be weighed depending on the specific social media platform that is used or based on the intended audience? If so, what are these considerations?
The survey asks respondents to choose ONLY one of the following responses (and add additional comments):
  • Yes
  • No
  • Don't Know
The image below shows how respondents answered this question (ALL respondents vs. PHARMA respondents vs. Agency respondents). The image will be updated frequently. See the date stamp on the image for when it was last updated. To see the most up-to-date results, please take the survey yourself and you will be able to see a summary at the end.

Special Considerations

Many comments were submitted in response to this question. Some of these comments include:
  • Regulations should be harder on DTC communication and lighter or non-existent (beyond existing restraints) on physician/professional intended communications.
  • If a platform is a private group or a public discussion would maek a difference in the considerations.
  • Physician-only platforms should be treated differently than those open to consumers. Also, scientific data dissemination -- i.e. posting a link to an SDD press release -- should be evaluated as such, not as promotional materials. Third, allowances should be made for the limitations of platforms (e.g. Twtter's 140 character limit, space limits on search ad results, etc.).
  • Believe patients and caregivers should be able to "opt in" to pharmaceutical content. Some patients now more knowledgeable about their disease and the drug than physicians. They ought to be able to obtain any content and evidence they feel they need to be comfortable.
  • message size constraints should be taken into consideration.
  • If HCP based platform, that should fall into different parameters than if the SM site is with a public/consumer audience.
  • If guidance is platform-specific, Any guidance or guidelines will be irrelevant and out-of-date the day they are written
  • Balance, objectivity, imparciality, transparency are criteria that should guide any action no matter which platform is used.
  • Doctors, patients and other groups that may be targeted should be treated in the same manner; medical organizations should not be held accountable for comments on behalf of outsiders, as long as proper protocol for disclosure, disclaimer and transparency policies are clearly labeled on their sites and linked third-party sites.
  • When companies have involvement or influence over discussions or material presented on third-party sites it is more focused to an audience that a comment on a web blog made by an employee but both have the potential to provide product information or marketing.
  • Age: we need to stop advertising to the youth of america in order to satisfy corporate greed. Social media is one more way to indoctrinate people. My experience is that SM serves the organization in terms of PR, rather than serving as a robust, critical feedback mechanism from the consumer.
  • Twitter's format is simply too short for meaningful regulatory disclosures. Thus, bought-and-paid-for "Tweets (at a minimum), should be considered non-compliant advertising material by a manufacturer.
  • as with any other regulatory area, facts and circumstances will always be relevant in determining whether there is any deceptive practices going on
  • To a much greater degree than any other product (or service), prescription products (i.e., authorized by a qualified healthcare provider) should require regulation based on intended audience; basically, consumer versus provider.
  • If the outlet is only available to HCPs, there should be separate consideration.
  • The evolving and shifting nature of social media would make it unrealistic to develop different considerations for different social media platforms. It is better to try for guidelines that are generally applicable across different types of social media vehicles that attract varied audiences.
  • Available space (e.g., Twitter limitations) necessitates a difference in what is feasible.
  • Depending on platform: if it is push and no conversation is going to take place than different standards apply, however if conversation is going to be included and part than clearly need to define the scope of that conversation.
    In terms of timeliness in reviewing/posting comments on platforms such as Twitter, there should be different regulations vs. other platforms including Facebook, blogs, etc.
  • any platform that is not clearly marked as an advertisement or that the information provided was paid for by the company
    We should consider that platforms and audiences are not one size fits all and and weigh them as such. I don't necessarily have specific recommendations but with the evolution of social media, we don't want to pigeonhole ourselves into one regulatory story.
  • Should be possible to disclose in a manner consistent with social media platform -- space limitations or need for casual, personal tone. Standard should be to make a reasonable effort to disclose what ought to be disclosed in a way that fits a given platform or format.
  • guidelines on disclosure should apply to all social media and audience so that specific interest is clear.

WANTED: Answers to FDA's Questions Regarding Pharma's Use of Social Media
SPECIAL REPORT: FDA Regulation of Social Media

Also see:

When Are Third-Party Online Discussions Not Independent of Pharma Influence? Survey says...

In preparation for FDA's public hearing on the Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools, the agency is asking for comments on 19 specific questions (see "Let's Respond to FDA's Questions Regarding Its Regulation of Social Media"). These questions are included in my ongong online survey/questionnaire, which you can access here.

I am following the results of this survey closely and will provide updates. Here, I focus on this question:
When should third-party discussions be treated as being performed by, or on behalf of, the companies that market the product, as opposed to being performed independent of the influence of the companies marketing the products?
The survey asks respondents to choose one or more of the following responses (and/or add additional comments):
  • When marketer or agent sponsors the discussion (eg, provides a specific grant to independent 3rd-party host such as a patient advocacy group to sponsor the discussion)
  • When marketer or agent paid for the content (eg, paid patients for testimonials or otherwise provided compensation)
  • When marketer or agent paid for display ads to be run on specific discussion pages (eg, only discussions related to the product advertised)
  • None of the above
The image below shows how respondents answered this question (ALL respondents vs. PHARMA respondents vs. Agency respondents). The image will be updated frequently. See the date stamp on the image for when it was last updated. To see the most up-to-date results, please take the survey yourself and you will be able to see a summary at the end.

Non-independence of third-party content

Many comments were submitted in response to this question. Some of these comments include:
  • Also, when marketer or agent sponsors a partnership which drives the discussion. For example, if a pharmaceutical company partners with the American Diabetes Association on a program, or an ADA program is made possible because of a grant from industry it should be treated as being performed by the company.
  • Unless company is supplying the content or writing script for the discussion, the company is not responsible for the content - merely for any marketing done on or near the content.
  • I don't think companies should be responsible for 3rd party comments in a sidewiki for example.
  • The FDA is trying to control a technolgy that moves too fast.
  • If the grant is the sole support of the discussion and the patient advocacy, then I would mark that. If it is a grant to patient group and they then use it for a number of programs including the discussion without specifying it as part of the grant application, then no
  • Exceptions occur if a grant is provided and marketer has "no say".
  • Agent sponsorship does not have to trigger non-independence if there is full disclosure as is done in scientific journal publications.
  • Marketers or agents who take on projects about their company on their own behalf (who are not being supplementally paid for content), should not be tied to FDA regulations. Only those additionally compensated for their social media work should be held responsible for staying in line with industry regulations. However, once ad space is purchased or additional compensation is given, to company employees or agents of the company, there should indeed be stipulations in place to regulate usage.
  • When a marketer or agent sponsors the discussion and those making favorable comments to the them are direct or indirect beneficiaries. This would not be apply when who is making the favorable comment is an independent voice
  • Marketer or agent built or created the social media site/community tool for the sole use of the company (e.g., marketer or agent builds it own social network for patients vs. sponsoring an existing independent community)
  • When marketer or agent controls what is/isn't posted, i.e. if they screen comments.
  • I'm not concerned about display ads, because people know that an ad is a statement by the company.
  • If the third-party discussion is initiated by the company that markets the product being discussed, that may trigger non-independence.
  • Agree that all three should be treated as being performed by, or on behalf of, the marketer/company, but the first scenario, sponsorship, is less black and white. Should be disclosure for that first scenario, but it's not as direct line between marketer and content as in scenarios two and three.

WANTED: Answers to FDA's Questions Regarding Pharma's Use of Social Media
SPECIAL REPORT: FDA Regulation of Social Media

Also see:

Saturday, October 03, 2009

What Criteria Determine Substantive Pharma Influence Over Content on Social Media Sites? Survey says...

In preparation for FDA's public hearing on the Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools, the agency is asking for comments on 19 specific questions (see "Let's Respond to FDA's Questions Regarding Its Regulation of Social Media"). These questions are included in my ongong online survey/questionnaire, which you can access here.

I am following the results of this survey closely and will provide updates. Here, I focus on this question:
What parameters or criteria should be applied to determine when third-party communications occurring on the Internet and through social media technologies are subject to substantive influence by companies that market products related to the communication or discussion?
The survey asks respondents to choose one or more of the following responses (and/or add additional comments):
  • Marketer or agent paid for an ad on the page that is displayed based on the content of the page (eg, Google Adword on content sites)
  • Marketer or agent paid for the content (eg, paid blogger or Tweeter to write about product)
  • Any communication by anyone that is employed by, or is a consultant of, the manufacturer should be held accountable.
  • None of the above
The image below shows how respondents answered this question (ALL respondents vs. PHARMA respondents vs. Agency respondents). The image will be updated frequently. See the date stamp on the image for when it was last updated. To see the most up-to-date results, please take the survey yourself and you will be able to see a summary at the end.

Substantive Influence over Content

Many comments were submitted in response to this question. Some of these comments include:
  • In some cases the marketer can pay for content and not influence its content. This is CME and CE.
  • Any communication UNDERTAKEN ON BEHALF OF THE COMPANY by anyone that is employed by, or...
  • Content supplied by physician or healthcare professional that may have been paid or otherwise compensated/rewarded by pharma company.
  • Total transparency is imperative.
  • Key word in number two is paid. If a company provides a sample but does not pay the blogger, the company should not be held liable for what that blogger (or reporter or patient) says/writes.
  • Any communication by anyone that is employed by, or is a consultant of, the manufacturer should be held accountable.
  • If there is a contractual relationship between the communicator and the manufacturer by which the communicator receives any monetary or non-monetary benefit from the manufacturer.
  • The consumer needs to know clearly what Internet contents/communications are company controlled (and therefore regulated) versus all other content.
  • As long as there is a disclosure agreement and standards for conversation listed on the third-party site, those hosting the conversation should not be held liable for outside opinions expressed through the avenue they provide. Therefore, companies are only responsible for the output from those they pay to attribute to the sites they host on social media networks.
  • Marketer or agent built or created the social media site/community tool for the sole use of the company
  • If the blogger/tweeter has been paid to write about a product this information should be disclosed. I am hesitating over the 3rd point. There is so much variation in communication, I worry that a blanket "be held accountable" would have unforseen repercussions.
  • Pharmaceuticals are an opaque good. Thus, pharma companies should have contractual provisions to control the messaging -- and ensure the balance and accuracy -- of all messaging offered by any agent pharma retains, hires, employs or contracts with.
  • Substantive influence could also include non-monetary influences such as "wining and dining" or inviting bloggers to events or hiring bloggers as "consultants."

WANTED: Answers to FDA's Questions Regarding Pharma's Use of Social Media
SPECIAL REPORT: FDA Regulation of Social Media

Also see: