Tuesday, December 22, 2009

Shire Implements First Ever Integrated Phone-Assisted Social Network Marketing Campaign for ADHD!

In what has to be a truly innovative use of Twitter, Shire Pharmaceuticals launched a phone-assisted ADHD Support Twitter account (@adhdsupport). Instead of following other Twitter users and building up a community where followers can "direct message" the account, @adhdsupport suggests that people call the Shire Customer Service Center if they want to provide comments. The reason given: "At this time we aren't able to follow other users" (see screen shot below).

I decided to call the 1-800 number listed and ask why @ADHDSupport is "not able" to follow other Twitter uses "at this time" and when it will be able to do so. LISTEN TO THE PHONE CALL.

Phone-assisted social networking may not work for all pharmaceutical products, but it is well-suited for ADHD products because -- according to this Shire "ADHD: Not Just a Child's Disorder" fact sheet -- ADHD sufferers:
  • "Often take action before they consider the possible consequences."  Consequently, @adhdsupport would enable this behavior if it allowed ADHD sufferers to willy-nilly click the Twitter DM button to ask a question.
  • "In conversation, [ADHD sufferers] interrupt others [and] blurt out inappropriate comments." Again, a good reason to disable conversation with ADHD sufferers on Twitter. It's not likely to lead to any meaningful discussion if @adhdsupport gets "inappropriate comments" such as complaints about ADHD treatment!
  • "[ADHD sufferers] experience difficulty waiting in line or for [their] turn." There's no such thing as "your turn" in a Twitter dialog. You just type something and press a button whenever you want to say something. I should think Twitter is a good environment for ADHD sufferers. So this is really an argument against blocking DMs.
[I rephrased these as statements rather than questions as originally posed in Shire's fact sheet.]

Well, I'll wait for Shire to call me back and then see if I get more information.

Thursday, December 17, 2009

Pharma's 2009 Letter to Santa

An anonymous source just forwarded me this letter to Santa that was intercepted at the US Post Office in Washington, DC:

December 17, 2009

Santa Claus
aka Father Christmas, Saint Nicholas, Kris Kringle
Santa Claus House
100 St. Nicholas Drive
North Pole (visible from Wasilla, Alaska)

Dear Santa:

As you know, it’s been a tough year for the pharmaceutical industry. I could list all the bad news, but where to start? Well, first there’s this president and all these Democrats to deal with in Congress!

But let’s not focus on the negative!

As you may have heard, we DID deal with the Democrats by pledging $80 billion in drug cost reductions over ten years! That proves we have been good, doesn’t it Santa?

You may have read the news about the billions of dollars in fines we had to pay this year. I hope you understand that all had to do with PAST “naughty” behavior, not how we behaved in 2009. I know you won’t count that against us, as we very much would like to be on your list of “nice” industries.

Did I mention that the pharmaceutical industry’s reputation among US consumers is now a few percentage points better than it used to be? We have a better reputation than automakers and the financial industry, that’s for sure! I won’t even mention tobacco!

Enough about us! It’s time to give you our list. You know, the list of presents we’d like for Christmas, please. Here it is:

  1. A nice healthcare reform bill that does not include a “naughty” public option, that does not include the right of Medicare to negotiate drug prices, that does not allow reimportation of drugs from Canada, but that DOES increase the number of people covered by health insurance who will then be able to buy our products. That would be very nice!
  2. Do I need to mention how much we would like guidance from the FDA on how it will regulate drug promotion on the Internet and social networks? Right now, we are really hurting because we cannot advertise on Google. I’m sure you also heard from Google about this. It may be a bit too technical for you to understand, but just tell the FDA that we want the “one-click rule” to be sanctioned by them. They will understand what you mean.
  3. You have tremendous influence over consumers and the economy on a global scale. Therefore, I don’t think we are out of line requesting that you see to it that worldwide sales of drugs rebound to double-digit growth in 2010. Do you think you can manage that?
There’s a bunch of other presents we’d like to get – such as shutting down Senator Grassley’s anti-drug industry investigations – but, if we get the above presents, we can manage just fine.

Oh, I almost forgot one more wish…

We wish that all the children of the world can live together in peace, harmony and good health.


The Global Pharmaceutical Industry

Wednesday, December 16, 2009

Investors Have Questions About Pharma's Online Spending in 2010 and Beyond

Investors who own stocks or who are thinking of buying stocks of major online Health sites are worried. They have lots of questions about FDA's plans for regulating drug promotion on the Internet.

As we know, when FDA regulates, markets react. When FDA sent out those 14 NOV letters, for example, branded paid search engine marketing by pharma experienced a "Prompt, Precipitous, & Prolonged" Plummet (see here). That could have been just a coincidence; I have heard that Google is worried about an overall decline in paid search engine advertising.

Anyway, an Internet research team at a major regional brokerage and investment banking firm that provides investment advisory services to individual investors and professional money managers invited me to speak to some of their clients via conference call about the recent FDA public hearing on the Internet and its repercussions.

Obviously, they think I am some kind of pharma marketing genius! But little do they know that I stand on the shoulders of giants – you! Therefore, please help me answer their questions and I will be forever in your debt!

Please take a few minutes to provide your input on the questions posed to me by this group. I am not receiving any payment for this, so you needn’t worry about being cheated by giving me your insight gratis. As a thank you, however, you will be able to download the latest issue of Pharma Marketing News after you complete the survey.

But Hurry! I need your input before 10:30 AM, Thursday, December 17, 2009!

Your comments are confidential (anonymous) unless you specifically provide your contact information at the end of the survey and allow me to attribute comments to you personally.

Click here to give me your comments.

P.S. Here is a presentation of my PRELIMINARY answers to the questions:

Tuesday, December 15, 2009

Will Patients Find Value in Discussions with Pharma Marketers on Social Media Sites?

At the November, 2009, BDI Forum in New York City ("Healthcare Social Communications Leadership Forum Breakfast"), a question from the audience to a panel I was part of got to the core of the value of pharma to online patient communities. The question was "Should pharma be in discussion forums or lists frequented by patients? Do we need an industry consensus where we shouldn't go?"

My colleague on the panel, Jonathan Richman (@jonmrich) noted that some consumer advocates speaking at the recent FDA public hearing said that under no circumstances should pharmaceutical companies be allowed to engage consumers in discussions on social networks. Jonathan thought that was too extreme. He suggested a few examples where such discussions could bring some value to the online patient community. He said there is data to suggest that patients/consumers would value the discussion if done the right way.

The problem is the TOTAL LACK OF PATIENT REPRESENTATION in this discussion! We've heard opinions of agencies and seen data from studies sponsored by agencies, but what are the views of real patients who have been using social media for years?

Gilles FrydmanWhereas other speakers at the BDI Forum used their complementary passes to invite colleagues from the industry, I used mine to invite the patient caregiver and advocate to the BDI discussion. That person is Gilles Frydman, founder of the Association of Online Cancer Resources (ACOR), a venerable and vibrant online community of cancer listservs that has helped more than 600,000 cancer sufferers and caregivers for over 13 years!

If you do not know what a listerv is, you cannot be blamed too much. Google doesn't index discussions that occur on listervs, so how would you ever find out about them? But patients have found them. More importantly, patients and their caregivers have STARTED them!

In 1995, soon after Gilles' wife, Monica, discovered that she had breast cancer, Gilles created ACOR and the world of Internet resources for cancer patients has never quite been the same since. ACOR's 159 listservs deliver over 1.5 million email messages per week, none of which you can find on Google.

At the BDI Summit I waited patiently until the opportunity was right to introduce Gilles to the audience and give him a chance to speak. I suggested that we ask the ONE person in the audience who could really answer the question put to the panel: Gilles.

Here's some of what Gilles said:
"I have been listening for close to an hour now about social media. The patient has NOT been present. It's completely amazing! You're still thinking broadcasting. Bring the patient voice to YOUR conversation and you will know what you are dealing with. If not, you will bring to the FDA a completely false idea of what's going on. Five million people participate in health-related listservs. This far surpasses the 35,000 patients on sites like PatientsLikeMe in which maybe 9,000 are active.

"Social media is OLD! Eighteen years old at least!

"Industry should get together and find ways to ask these people how to best communicate with them. If you do this, within 6 months you will be able to put together a document for the FDA that will mean something."
There are many people out there who CLAIM to speak for patients but who are actually running businesses that aggregate patients in order to serve them up to marketers. Gilles suggested that the industry BYPASS these middlemen and go directly to the patients who use social media.

To learn more about Gilles' point of view, join me in a LIVE podcast interview today at 1:00 PM Eastern: "ACOR: An Online Social Networking Community of Cancer Patients & Caregivers Pharma Can't Join But Can Learn From".

Some questions we will discuss:
  • Tell us about ACOR, including why you created it?
  • What are listservs? Why haven't you adopted some of the newer Web 2.0 tools?
  • How have ACOR patient communities interacted with pharmaceutical companies in the past and how do you see working with them in the future?
  • What can pharmaceutical researchers and marketers learn from ePatients? Anything?
  • What are some of you criticisms of the "new" social media fad?
  • What future plans to you have that nay be of interest to pharma marketers?

Friday, December 11, 2009

Finally. Individuals Speak Out Pro & Con (Mostly Con) About Online Pharma Marketing

The comments are dribbling in to FDA regarding whether or how it should regulate the use of the Internet by drug companies for promotion of its products. Either that, or www.regulations.gov, which is collecting the comments here, has a growing prostate problem that affects its information release "stream."

Each week I will take a look at the site and see what new comments have been made public. You can find the first bunch here. I include a selection of the more juicy ones below. I especially focus on those submitted by individuals, most of whom are critical of pharmaceutical marketing and advertising. I do this because these voices were noticeably ABSENT from the "public" hearing in mid-November.

Michael E. Bailey/individual:
The manufacturers of medications and their representatives must be held accountable for each claim they put on any online media concerning their products because the public health and safety demands it. There maybe some online media that are not suited for drug advertising because of the space limitations involved. There may not be enough space for the important risk information that needs to come with the claims. It is too risky and dangerous to allow the drug company claims alone without the risk information. It is not enough to put in a link that you can click on to take you to another site to get the risk information because many people won't do that and will only read the claims of the drug company that it puts up on the social media. But they should always provide a link to the FDA website for people who want an unbiassed and fair assessment of the drug, and so people can report bad reactions to the drug. Thank you and best wishes, Michael E. Bailey.
Bruce Overman Jr/Individual:
I and many, many others are very much against any further promotion or advertising of Food and Drug Administration-Regulated Medical Products, particularly prescription drugs. I am very much in favor of outlawing the existing practice of advertising prescription drugs. Billions of dollars are spent by pharmaceutical companies to advertise drugs, confusing and misleading the public, most of whom do not have the expertise needed to make proper judgments where these drugs are concerned. This massive amount of money should, instead, be used to reduce the cost of these drugs.
Randall Pecsek/Individual:
The last thing this country needs is MORE advertising by drug companies. Prescription drugs need to be administered by doctors acting in the best interest of their patients. Patients need to talk to their doctor about a medical "problem", and let the doctor determine the best treatment. Drug ads serve only to feed hypochondria in the public. Marketing of drugs and the costs of advertising serve only to drive up prescription drug costs in America. Our capitalist system is out of control, driving Americans to spent money frivolously. Let's not expand advertising opportunities, let rein them in and recind the rules which allow drug companies to advertise anywhere except medical journals intended for doctors. How many more erectile dysfunction ads do we need to be subjected to?
Kathryn Rowerdink/Individual:
I believe transparency is requested for all of the healthcare industry. Prior to twitter, facebook etc. the public was posting comments on drugs (pros and cons). I have googled drugs by their marketed and generic names to read about other peoples' experiences. I had some reactions to a steroid medication I was prescribed and wanted to find others who might have experienced the same. Doing a search and finding the right forum was extremely difficult and time consuming. A drug makers facebook page or a separate page for each drug was available, it would have made life much easier. A Facebook etc with non-censored updates, stories and comments etc. would have helped me and been faster. If the drug companies and insurance companies (although this is not the topic for the FDA)agree not to censor comments and stories, this is e a great avenue for information exchange. The pros and cons of a drug are more easily assessed through other peoples experiences and comments. Regulations and laws have forced the drug industry to use very complex wording in the packaging (in good faith of full disclosure) however this not helpful to the consumer but overwhelming. I would much rather go to a social media site and view what the possible tangible experiences are so that I may weigh my options and assess the risk. If the FDA chooses to regulate social media I do not see how this is a move toward transparency. The more the FDA represses communication avenues the less people feel informed. Regulating the censoring of comments etc. should be enforced but there are too many loopholes in trying to prevent the healthcare industry from engaging in new communication avenues. The FDA should encourage communication between patients and drug makers. Not only will this help the drug companies to assess needs and fill gaps but consumers are more likely to make their voices heard and feel empowered.
Patrick Rockhill/Individual:
Medical products must always state side effects. I recommend that the FDA increase regulation to include that Internet users must always be presented with an easily readable screen describing side effects and an acknowledgement button before users can proceed onto any "features" or "benefits" of medical products.

Wednesday, December 09, 2009

Will Pharma Spend More on eMarketing than on TV Advertising by 2019?

TNS Media Intelligence reports that U.S. Advertising Expenditures Declined 14.7 Percent in First Nine Months of 2009 compared to 2008. Bucking that trend was the Pharmaceuticals sector, which increased ad spending by 0.6 percent (from $3,462.7 million to $3,483.6 million) in that period.

If pharma DTC spending in the final quarter of 2009 continues at the average rate during the first three quarters, the total spend in 2009 will be about $4.7 billion, a 7.1% increase over 2008 (see chart below).

NOTE: TNS MI looks only at measured media, including: Network TV; Spot TV (122 DMAs); Cable TV (71 networks); Syndication TV; Hispanic Network TV (4 networks); Consumer Magazines (231 publications); Sunday Magazines (7 publications); Local Magazines (22 publications); Hispanic Magazines (14 publications); Business-to-Business Magazines (278 publications); Local Newspapers (143 publications); National Newspapers (3 publications); Hispanic Newspapers (47 publications); Network Radio (5 networks); Spot Radio; Local Radio (32 markets); Internet (DISPLAY advertising only, not search engine advertising, which can be 40% of the total Internet ad spend); and Outdoor. Figures do not include public service announcement (PSA) data.

I had predicted a further decrease in DTC spending in 2009 (see "DTC Spending Will Be Decimated in 2009, Experts Say") and this can still happen because the 0.6% increase so far is pretty slim. If Q4 spending is only $716 million instead of the $1,161 million estimated to create the chart above, then my prediction will come true.

Speaking of predictions, I have a new survey: Predicting the Future of the Drug Industry: 2010 and Beyond! Among the predictions I am seeking opinions on is this one:
Internet-based drug promotion (including search engine marketing) will overtake TV-based DTC in the U.S. in terms of dollars spent (by 2019).
TNS MI reported a 7% increase in Internet display advertising in the first nine months of 2009 vs same period in 2008. Meanwhile there was an 11.5% decrease in network TV advertising during that period and a Q3 spending tumble of 25.1%. Pharma Internet display ad spending more than tripled in the nine-month period to $221 million according to DTC Perspectives.

Even doubling that figure to account for search engine advertising, the amount that pharma spends on the Internet vs TV is miniscule ($221 + $200 million for SEM = $421 for total Internet ad spend first 9 months; Internet portion of spending pie = 12% vs 60% for TV).

Is it possible, therefore, for Internet ad spending by pharma to exceed TV ad spending by 2019? Well, about 56% of respondents to my survey think it is somewhat or highly likely to happen!

What do you think? Please take my survey now. The survey also asks your opinion about the following predictions:
  • New follow-on biologics legislation in the U.S. will increase competition from generic equivalents and eventually decrease brand profits
  • Broadcast (ie, TV) Direct-to-Consumer (DTC) drug promotion will be banned or sharply curtailed by law in the U.S.
  • The European Union will finally allow Direct-to-Consumer (DTC) advertising to its citizens
  • Due to decreasing effectiveness of traditional physician detailing and rise of non-personal detailing, the role of traditional sales representative will become obsolete
  • New healthcare reform legislation will dramatically increase the sales of drugs in the U.S.
  • Extensive outcomes data available to payers and comparative effectiveness research will force the industry much further down the path of pay-for-performance (ie, adopt a more flexible approach to pricing)
  • Patients will become even more influential and empowered in making healthcare decisions as they are forced to pay a larger share of costs and/or have access to health information from a variety of sources
  • Despite lack of innovative new drugs and/or generic competition, sales of brand drugs worldwide will show a sharp increase due to increased demand in emerging markets (eg, China)
  • More efficient targeting of drugs and marketing to specific patient populations6 will greatly increase effectiveness and decrease side effects of drugs
  • Social media marketing7 will become a significant part (>10%) of the pharmaceutical marketing mix
  • The next BIG opportunity for targeted marketing to patients and physicians is mobile apps on "smart phones"
  • Pharmaceutical and biotech companies will continue to increase their outsourcing of clinical trials and related drug development. Outsourcing will account for more than 50% of R&D spending by 2019.
Afterward you will be able to see the up-to-date results AND be able to download FREE Pharma Marketing News reprints covering many of the issues involved in these scenarios.

Tuesday, December 08, 2009

Premature Social Media Promotion (PSMP): A New Pharma Syndrome

I've heard of pharmaceutical company blogs that were launched to promote a drug already on the market (ie, alliconnect), but I haven't seen a blog that was launched to promote a drug that isn't yet approved for marketing - until now!

According to Jonathan D. Rockoff at WSJ Health Blog,  Sciele, which is a unit of Japanese pharma Shionogi, "has been pursuing two tracks to raise awareness [of premature ejaculation]. For months, it has sought to educate physicians about premature ejaculation, making presentations at medical meetings. Last month, after Phase 3 studies finished, the company launched a Web site for bloggers with information about the condition and scientific milestones in their product’s development" (see "Premature Ejaculation: Marketing the Condition Before the Drug").

The website is actually a blog. Like any other blog it consists of posts and has a number of buttons you can push to share posts on Twitter, Facebook, LinkedIn, etc.

It includes a "Premature Ejaculation (PE) Fact Sheet," which I have adapted here to create my "Premature Social Media Promotion (PSMP) Fact Sheet":

PSMP affects an estimated one-third of U. S. pharma companies, making it twice as prevalent as Web 1.0 promotion (W1P).
  • Unlike W1P,  PSMP is NOT brand-specific – it can occur at virtually any stage in the drug development cycle.
  • Despite its prevalence, until recently there was no universally agreed upon definition of PSMP, leaving the pharma marketing population underserved.
PSMP Definition
The International Society for Social Marketing of Drugs defines PSMP as the most common pharma social media marketing dysfunction characterized by:
  • Ejaculation which always or nearly always occurs seconds after the ad agency makes a proposal to develop a social media marketing campaign; and
  • The inability to delay approval of all or nearly all social media agency penetrations of a marketing department; and
  • Negative personal consequences, such as being fired, bother, frustration and/or the avoidance of the product brand director.
Causes/Risk Factors
PSMP may have physiological and psychological components, but the exact cause of PSMP has not yet been determined. Until recently, there was not an internationally agreed-upon, evidence-based definition of PSMP so its causes and risk factors are still being determined although it is strongly believed that excess exposure to non-pharma interactive agencies is to blame.

Currently, consumers do not screen for PSMP but rather discover the condition following a Google search link or a Tweet from a friend, and often times do so without thinking.
  • Survey data indicate that pharma marketers are reluctant to discuss premature marketing issues with the trade press and that the editors generally do not initiate discussions of such issues.
Effect on Relationships
PSMP  is highly associated with negative experiences in traditional marketing interactions with consumers and the press. In an observational study of pharma marketers with PSMP and their vendor partners, 64 percent of marketers reported high levels of distress while only 24 percent of vendors reported high levels of distress.

To date, no prescription drug has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of PSMP. However, thinking about TV advertising often works.

Transcripts of FDA's November 2009 Public Hearing on Social Media Available

You can find the transcripts here:

Friday, December 04, 2009

Is the Pharma Social Media Bubble About to Burst?

It may turn out that the recent FDA public hearings on Pharma's Use of Social Media was a turning point in the brouhaha over social media in the pharmaceutical industry. It was, after all, a festival by and for agencies with an agenda to push pharma marketers over the social media precipice and thereby make a lot of money.

But it appears that the drug industry was primarily interested in one thing and one thing only: the ONE-CLICK RULE for use in search engine marketing and perhaps to PUSH 140-character branded ads out through Twitter. Of secondary interest was MONITORING social media but not really engaging in any meaningful CONVERSATION.

I feel the bubble of social media hyperbole is about to burst. There's a T-shirt for that!

Pharmacos Spend More on DTC Advertising When There is No Competition

A new report from the Congressional Budget Office (CBO), "Promotional Spending for Prescription Drugs" (find it here), counterintuitively suggests that "drugs with little competition are likely to be marketed to consumers far more aggressively than drugs with a lot of competition" (NY Times). According to the report:
"Pharmaceutical manufacturers tend to spend more, on average, on DTC advertising for drugs that have few or no direct competitors (meaning there are few other drugs that treat the same condition using the same mechanism) than on products with numerous alternatives. Excluding some classes of drugs with the highest-selling and most advertised drugs -- where a drug’s potential market size might overwhelm other factors in setting a marketing plan -- the data analyzed by CBO show that average spending per drug on DTC advertising generally declines as the number of competitors in the same class increases (see Figure below). When a class includes more drugs, pharmaceutical manufacturers tend to spend less, on average, on DTC advertising because the benefits of that advertising (higher sales) may be diffused among the other drugs in the class."
"A monopoly," says the NY Times reporter, "reaps any benefits of its advertising alone."

The report notes that physician detailing expenditures do not exhibit the same relationship between average spending and the number of competitors in a drug class.

The thinking is that if you promote a drug having competitors, it's just as likely that a competitor drug will be prescribed as will be your drug. This interpretation is consistent with other data -- from ad agency sources -- which concludes that DTC advertising does NOT result in consumers asking their doctors for the advertising drug by brand name (see "Advertisers Don't Know How DTC Works. Say wha?").

It appears that DTC may be used as a tool to maximize profits during the period when the drug enjoys a monopoly. Higher prices can be charged during this period because there is no competition. Hence, a link between DTC and high drug prices (see also "Did State Medicaid Programs Finance Plavix Direct-to-Consumer Advertising?").

Some critics of DTC advertising say that drug companies should wait one, two, or three years before advertising new drugs to consumers. The rationale is that new drugs may have unknown risks that may not be seen until used for a few years.

PhrMA's DTC Principles waffles on the issue: "In order to foster responsible communication between patients and health care professionals, companies should spend an appropriate amount of time to educate health professionals about a new medicine or a new therapeutic indication and to alert them to the upcoming advertising campaign before commencing the first DTC advertising campaign."

A few pharmaceutical companies have agreed to a voluntary 6-month or 1-year moratorium on DTC advertising for new drugs. Some experts say that DTC typically does not begin immediately after approval in any case.

However, a moratorium of 2 or 3 years would drastically reduce the profitability of those drugs that are "first-in-class"; ie, those without competition in the first few years on the market. I suspect that this is the main reason why drug companies are resisting efforts by lawmakers to impose a long moratorium on DTC. By offering a voluntary 6-month moratorium, drug companies seem to be compromising but really are not offering anything they have not alread been doing.

The chart below for CBO shows that promotional expenditure usually peaks 1 to years after approval for marketing.

Thursday, December 03, 2009

Atlas Did NOT Shrug! FDA Makes (Some) Comments Public

Yesterday, I started my Quixotic quest to impel the FDA to make available for public viewing the comments that have been submitted to Docket FDA-2009-N-0441: Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools (see "Dear FDA: Where Are the Public Comments Regarding Regulation of Internet, Docket FDA-2009-N-0441?").

Before I posted that entry in this blog, I e-mailed Jean-Ah Kang, Special Assistant to the Director, DDMAC - CDER, and asked why comments were not visible to the public.

Within a few hours she responded: "FYI, we are working with our counterparts in the Division of Dockets Management to ensure that all comments are posted for public view."

A few hours later, lo and behold, several comments and documents that were posted on December 2, 2009 were visible and available to download.

This quick response seems to have caught some of my FDA-knowledgeable and government-skeptical (Ayn Randian) readers by surprise as you can see from this discussion on my Facebook page:
Bruce Grant (@grantbw): John -- Check 21 CFR for regs for FDA Part 15 procedures. Public comments are made public ***once all the comments are in""* (i.e., once the docket is closed in February, 2010). FDA official response (possibly including answers to the questions you pose above) will come later -- most likely in the form of a draft or final guidance document.

John Mack (@pharmaguy): Well, I guess that's that then! BUT, one comment IS public and it was stated that it may take several weeks for comments to appear. If what you say is true and FDA MUST abide by the regs, why not say so during submission process?

John Mack: I think I found part 15 and I don't find what you mention. It merely states: "A person may submit information or views on the subject of the hearing in writing to the Division of Dockets Management, under §10.20. The record of the hearing will remain open for 15 days after the hearing is held for any additional written submissions, unless the notice of the hearing specifies otherwise or the presiding officer rules otherwise."

Bruce Grant: In this case the record is being held open until February, 2010 and won't be made public until it is closed. Regulations.gov seems to be an entirely different channel...not actually connected to the Part 15 process. And it seems not to be monitored closely. It was originally supposed to be a channel whereby you could register "electronically" to attend the November hearings...but everybody I knew who tried that ultimately had to send snailmail directly to Jean-Ah Kang to get in.
John Mack: Yeah, jean-Ah did apologize for the way comments were being handled through Regulations.gov. But, tell me, can you cite the reference for your belief that the record won't be made public until comments are closed? And is there a difference between part 15 hearing requirements and a comment period AFTER the public hearing?
Dmitriy Kruglyak (@dkruglyak):  A mis-managed, incompetent, clueless, secretive, defensive government agency? No way, it cannot be true!

John Mack: Dmitriy, I love it when you channel Ayn Rand!

Dmitriy Kruglyak: I am a proud Randian! By the way, check out the song/video I just posted on my profile, you'll love it.

John Mack: Well, I'm not an anti-tax advocate, but I agree with everything in that song!

Dmitriy Kruglyak: Exactly! I guess doubting government's ability to do anything right is not considered "crazy" anymore!

John Mack: Calm down. There's lots of things that the US government does right and that I am very proud of. If only those were a higher percentage of what it does, there may be no more Randians!

Dmitriy Kruglyak: I love being proven wrong about it, unfortunately they are a long way from winning over Randians!

John Mack: I just received an e-mail response from Jean-Ah Kang, Special Assistant to the Director, DDMAC - CDER, in response to this post. "FYI," said Jean-Ah, "we are working with our counterparts in the Division of Dockets Management to ensure that all comments are posted for public view."

John Mack: Lookee here. Comments begin to appear in Docket after I complain to Jean-Ah Kang: http://bit.ly/17ijQb

Dmitriy Kruglyak: Guess not all hope is lost. The real question is what happens when nobody is looking.
Randians like Dmitriy are not convinced that any agency of government can do any good. This time, however, Atlas (ie, FDA) did not shrug, but responded to criticism quickly and actually corrected itself.

Unfortunately, however, only a few -- less than a dozen -- comments are available for public view on the www.regulations.gov Web site. All of these were submitted by 2-3 people (myself included). Where are all the others?

By all means, LET'S KEEP LOOKING! You too, Dmitriy and all my other Randian friends!

Wednesday, December 02, 2009

Dear FDA: Where Are the Public Comments Regarding Regulation of Internet, Docket FDA-2009-N-0441?

A public service message from FDA Intern:

Not only does FDA Intern want to know where all the comments are, I want to know also! It's been over 2 months since the FDA called for comments and three weeks since the public hearing. But there are NO comments available to view on the www.regulations.gov docket here. There is ONE question that was submitted on September 22, 2009, but no comments.

I submitted a comment this morning. It was the script and PowerPoint deck of the presentation I made during the first day of the public hearing. Here's the confirmation screen:

My comment is not yet publicly available. When you submit a comment, you are warned that it may take "several weeks" for it to be available in the public docket. Why is that? I notice that Docket: FDA-2009-N-0294 (Regulation of Tobacco Products; Request for Comments) has over 800 comments publicly available -- the first one was submitted 2 days after the notice was published on July 1, 2009. More importantly, the last comment was submitted YESTERDAY and is now publicly viewable!

So, where are the public comments for Docket FDA-2009-N-0441?

Having comments publicly available as soon as possible should be part of FDA's Transparency Task Force.

More Questions
When will comments be made public is just one of the MANY questions stakeholders want to ask the FDA about the process following the public hearing. I have posed a few others in the "What Happens Now?" survey I started on 19 November 2009 (access it online here). You can pose your own question and/or chose one or more of the following as the questions you'd like answered by the FDA:
  • Will ALL the written comments submitted to the docket be made available to the public for viewing?
  • Will the first guidance be considered "draft"?
  • When will the first guidance be issued?
  • Is there another comment period after the first (draft) guidance is issued?
  • Will the guidance be organized by topics similar to how the docket was structured?
  • Does the FDA plan to be more proactive in reaching out to more stakeholders -- patients, public, and physicians in particular -- during the comment period?
  • If so, How will it do that?
  • What can we do to help?
  • Does the FDA plan to pull in any outside consultants, or hire additional experts internally, to help craft the guidelines?
  • In the meantime, will FDA pre-approve search engine ads, especially ads using Google's new format?
So far, here's how respondents voted:

Fabio Gratton, Chief Innovation Officer at Ignite Health, has been diligently working to collect a list of questions for the FDA based upon responses to my survey and collected by him here, where he is organizing them into categories.

Once Fabio and I have collected a thorough list, we will send it to the FDA. Realistically, the Agency might not be able to answer all the questions, but we believe any answer will provide us with more insight than we have now. It certainly will help FDA understand our concerns.

I just received an e-mail response from Jean-Ah Kang, Special Assistant to the Director, DDMAC - CDER, in response to this post. "FYI," said Jean-Ah, "we are working with our counterparts in the Division of Dockets Management to ensure that all comments are posted for public view."
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