Tuesday, November 30, 2010
Monday, November 29, 2010
In that essay -- published in the Economist (here) -- one paragraph stands out: "Art, not just science" is the heading, under which Witty says: "First, we need to recapture the ability to empower creative talent in the discovery phase of r&d by creating an environment in the labs that reflects the fact that discovering a drug is as much an art as it is a process."
Maybe Witty envisions "Jackson Pollock" wannabe lab researchers throwing chemicals against a wall & seeing what sticks?
Sunday, November 28, 2010
After a day of cooking, I spent the remainder of the Thanksgiving Holiday weekend reading and highlighting sections of the 144-page brief that the Center for Digital Democracy (CDD) filed with the FTC on Thanksgiving eve (see "Center for Digital Democracy Challenges FTC to Reign In Online Pharma Marketing").
This document -- now in the public domain (find it here) -- is perhaps one of the BEST reviews of healthcare-related digital marketing techniques that I have ever seen! I recommend that ALL pharma marketers read it to learn which companies to contact to help them do a better job reaching online consumers and physicians.
There were several companies and products mentioned that I have not heard of. In that regard, this brief -- negative though it may be -- is a promotional boon for these companies, IMHO. You can't buy this kind of publicity and as a recent article in the New York Times proves, even negative publicity can help you get top listing in Google searches (see "A Bully Finds a Pulpit on the Web").
I compiled a list of more than two dozen innovative online marketing products/solutions mentioned in the CDD brief. My list includes the product name, company/site name, description, link to online information, and the paragraph number in the brief where you can find what the CDD has to say about it (download the list here).
If your company is NOT listed, I suggest that you (1) contact CDD and ask them to amend their brief to include your solution and/or (2) file your own brief with the FTC.
Of course, CDD does not view these solutions as "innovative." In fact the CDD thinks they are "unfair and deceptive":
"The companies named in this complaint, as well as others involved in real-time tracking and bidding -- including those that provide data optimization services for profiled targeting -- are engaged in unfair and deceptive practices."I must admit that one or two of the services were a bit scary. QualityHealth's "Focus on Formulary" solution, for example, claims to be "sophisticated technology" that "links consumer marketing with brand formulary access." It designs "targeting messaging directly to millions of profiled consumers based on prescription coverage." CDD says: "Few consumers likely realize, however, that they have consented to become the subjects of a 'proprietary profiling technology' that “captures… valuable information across over 100 individual data points,” including 'consumers’ conditions and preferred treatments'; 'doctor relationships and plans to visit the doctor'; and 'insurance and formulary coverage.'"
ConditionMatch (offered by Good Health Media) claims to use “cutting edge behavioral targeting technology…[and] identifies groups with common sets of conditions/health-related characteristics by geographic region via insurance claims and individual ‘opt-in’ data.”
Both sound like they may have HIPAA privacy issues.
There is no lack of innovation regarding the names given to some of these solutions, such as:
- ActuatoRx Geo-Medical Targeting
- Intent Targeting Advertising
- Target 2 Measure
- Social Operating System
- Bizo Targeting Platform
- Quantemo Engagement Index
- Subconscious Resonance Testing
- Evoked Response Potential
Which leads me to wonder why the CDD focused exclusively on healthcare marketing as a target for its critique. Many of the marketing tactics cited by CDD probably were first developed for the consumer goods industry and then renamed/rebranded to appeal to healthcare marketers as well. The CDD has helped accelerate the process!
Tuesday, November 23, 2010
Today, the Center for Digital Democracy filed a 144-page brief with the FTC challenging that agency to investigate its charges that Google, Microsoft, QualityHealth, WebMD, Yahoo, AOL, HealthCentral, Healthline, Everyday Health, and other health marketers -- including major pharmaceutical companies -- have "unleashed an arsenal of techniques to track and profile consumers" in an unfair and deceptive manner.
In the brief, which you can download here (huge pdf file), the CDD urges the FTC to "immediately conduct a thorough investigation and analysis of contemporary Digital Direct Marketing to Consumers of drug and health-related products and information. In addition to seeking the appropriate injunctions and other relief, we also urge the FTC to issue a report and recommendations designed to inform consumers and health professionals of the issues raised by interactive ads for medical products and services."
CDD has a long list of specific requests that can be found on the last few pages of the brief. I'll list a few of the more juicy ones here.
CDD says FTC should
- "Examine and analyze the data collection and usage practices of pharmaceutical advertisers to assess the extent of consumer information collected through websites, social networks, online video sites, and other interactive means. This should include personal information, IP addresses, cookies, flash cookies, Web bugs, tracking pixels, Web analytic tools, conversational and sentiment analysis [my emphasis], and any other 'data-mining' applications. We urge the FTC to resist suggestions that such data collection methods are appropriate because they can help identify risk-averse-related information."
- "Analyze how health-related social media marketing influences consumer behavior and attitudes on drug use and about medical conditions. The agency should examine social media marketing applications for the health market designed to foster 'viral' marketing approaches, including the targeting of specific consumers in order to influence their own network of relationships."
- "Investigate whether there is a violation of the FTC’s Endorsement guidelines (which the FTC has extended to the Internet) when advice is given to patients or consumers from seemingly independent health bloggers who do not disclose that they are paid or sponsored by pharmaceutical or other companies."
- "Obtain from pharmaceutical companies a list of the keywords used for paid search campaigns. The companies should also be required to inform the FTC of the techniques and applications they may use in so-called organic search to show up prominently in the results. U.S. consumers should be informed by the FTC of the implications of search marketing practices when they are looking for information and advice.
- "Work with the Food and Drug Administration and other appropriate agencies to develop a set of policies for regulating the use of behavioral targeting, data collection, and other digital techniques in the marketing of drugs and health-related products."
Monday, November 22, 2010
While cleaning out my basement I came across a box that contained the premiere issue of "The Net," a magazine published in June, 1995. I saved this magazine because my photos of Paris were featured in an article about "Le Louvre," a popular Website of the time (see image below, which shows the cover and the page with my photos; click on image for a larger view).
The author of the article claimed that WebCrawler -- the first Web search engine to provide full text search that went live on April 20, 1994 -- found 308 links to the "Le Louvre" site. This was enough in those days -- BEFORE Google -- to make a site "popular." Today, a Google search on "Le Louvre" yields 4,380,000 results!
But the article actually talks about "Treasures of The Louvre," which wasn't the official Web site of the famous museum! It was a series of pages put online by a UCSD student. Around the same time, the "unofficial" Glaxo pharmaceutical web site was created by a single employee without the knowledge of executive management! Can you believe it?
Anyway, my photos were not part of the "Le Louvre" site but were included in a site about Paris, which was linked to "Le Louvre" (wow, the WWW is nifty). My section of that site was titled "A Personal View of Paris." I am happy to say that "John Mack's Views of Paris" is still available on the Web here on the www.paris.org site.
Some of the other Internet pioneers and pioneering apps, however, are no longer available or relevant. These include "Gopher," "Archie," "WAIS," and "Veronica." Ah, my first loves!
BTW, I was providing pharmaceutical information on the Web even before 1995. In 1994, I teamed up with Oncolink to post articles about new oncology drugs. Oncolink was started by an employee of the University of Pennsylvania. His daughter had cancer and that's why he developed the site. Later the University took over this most popular health site on the Net, without so much as a thank you to the creator! It now claims the site "was founded in 1994 by Penn cancer specialists."
After that -- in 1995 -- I launched my own pharmaceutical site called "PharmInfoNet" and the rest is history.
Posted by PharmaGuy at 11:52 AM
It's always been difficult to get a handle on the amount of money pharmaceutical companies spend on promotion to physicians and especially how much of the total spend is focused on "e" channels such as Web advertising and Internet detailing. Several different companies offer estimates that vary depending upon exactly what they include when totaling up the numbers.
But no matter what the source and how the numbers differ, my analysis is always the same: spending in the "e" space is a tiny fraction (less than 5%) of total promotional spend and has remained in that range every since I can remember!
Today, I received a summary of a report from SK&A, a market research company, titled "U.S. Pharma Company Promotional Spending Trends in New Media" (see here). Of interest to me were the sections on "New-Media Average Monthly Expenditures, 2006 to 2010" and "Promotional Expenditures by New-Media Channel, Oct. 2009 to Sept. 2010." Again, the numbers show that pharma spends very little on ePromotions or "New Media" promotions or whatever you want to call it.
According to this report, "Pharmaceutical companies are finding novel ways to promote their products to physicians and other prescribers, namely through new media channels such as internet detailing, tele-detailing, e-meetings and web advertising." It's interesting that the telephone (as in "tele-detailing"/"Telephone Detailing") has been included as a "new media" channel. And here I thought the telephone was invented over 100 years ago!
SK&A says that "tele-detailing" accounts for 49% of the new media channel physician promotional spend, whereas "Internet Detailing" is only 35% and Web advertising is a meager 1% (see chart below).
The report claims that "In the U.S., promotional spending [aimed at the HCP audience] totaled $24 billion between October 2009 and September 2010." Thus, "New Media" spending represents ONLY 1.4% of the total spent on promotion to physicians by pharma companies. If we eliminate the $160 million spent on telephone detailing, that percentage drops to 0.7%!
But I bet the $24 billion includes the retail cost of samples, which could account for as much as $18 billion a year (see here). If so, then only $6 billion was spent on non-sample promotion to physicians and 2.8% of that went to "true" new media (ie, not telephone detailing).
But "New Media" promotional spending is increasing by leaps and bounds according to the report, which states "[monthly] promotional spending in new media has increased significantly from about $5 million in January 2006 to about $26 million by September 2010" (see chart below).
Again, telephone detailing is included in the "new media" category. It could be that ALL of this "significant" increase is due to docs receiving more telephone calls from sales reps!
FOLLOW UP: November 23, 2010. Rich Meyer over at World of DTC Marketing Blog clarified how "Telephone Detailing" works and why it may have been included under "new media" in the SK&A report.
"There are many types of electronic detailing including detailing by phone," said Meyer. "Phone allows physicians to hear a detail on demand along with an interactive presentation via the Web."See Meyer's complete post: "Detailing by phone: What do physicians think?"
Friday, November 19, 2010
The data will include results from clinical trial reports on three obesity drugs: Roche Holding AG’s Xenical, Abbott Laboratories' Meridia and Sanofis Acomplia. Acomplia was never approved in the U.S., and EMA pulled the drug from the market in October 2008. Abbott agreed to take Meridia off the U.S. market in October. The EMA halted sales of the 13-year-old diet pill in January. But Xenical is still available in Europe and both the EMA and FDA have allowed GSK to sell Xenical’s active ingredient, orlistat, as the non-prescription diet pill Alli.
Who knows what will come to light when this data is released. Anders Joergesen, a researcher at the Copenhagen-based Nordic Cochrane Centre, which called for the release of the data, said "It's a very detailed report describing the benefits and harms, more detail than is available for example in medical journals. The medical journal's report is about 10-15 pages, maybe less, and these consist of 100, 200, 300 pages per trial. Let's see what we get," said Joergesen, "because it may be fully redacted and a blank sheet."
After analysis of the diet drug clinical trail data, Joergesen and colleagues may do for Xenical and Alli what Cleveland Clinic's Dr. Steven Nissen did for Avandia -- ie, put sales in the toilet, exactly where Alli's "treatment effects" end up (sometimes; see "Alli Oops! I Just Pooped Myself!" and "Alli Newspeak: Oily Spotting is 'Treatment Effect'").
Thursday, November 18, 2010
The press release announcing Accenture's new "Consumer Survey: The Evolving Consumer and The Pharmaceutical Company Relationship" claims that the survey "suggests pharmaceutical companies are falling short in addressing this captive audience" (my emphasis; find the press release here).
It's unfortunate that the press release uses "captive audience" to describe consumers who go online for health information. To a marketer, a captive audience is a technical term (jargon) that merely means "people who cannot avoid being exposed to an advertisement."
The top line takeaway from the press release is that only "slightly more than one in 10 (11 percent) [of consumers who go online for health information] regularly turn to a pharmaceutical company’s website to seek information about an illness or medical condition, compared to nine in 10 (92 percent) who look to other online resources more frequently."
The press release then goes on to say that "pharmaceutical companies that are not fully leveraging multiple online channels are missing a real opportunity to address this captive audience. It also demonstrates that the fundamental shift from a predominantly one-way company-to-patient dialogue to enabling a patient-to-patient – and even a patient-to-physician dialogue – through the evolution of social networks and online communities, has resulted in fragmentation."
From this, you -- and probably many reporters as well -- might conclude that the answer to my question is that consumers are not going to pharmaceutical company web sites so much and that the drug industry better engage in conversation with consumers on social networks and patient communities.
But if you look at the details of the survey, you'll discover that social networks such as Facebook are visited even less often than pharma sites by online health information seeking consumers. See chart below (I created this chart from detail survey data sent to me by Accenture):
In other words, consumers are NOT flocking to Facebook to find health information.
So, why are pharmaceutical companies so interested in having Facebook pages, which, BTW, often do NOT allow comments? Simple. Facebook has surpassed Google in terms of Web site traffic ("eyeballs") and pharma marketers are still seeking this "captive audience" to display ads (ie, Facebook pages), not to engage in conversation (for more on this, see "Drug Companies Are Flocking to Facebook for Eyeballs, Not Conversation").
Tuesday, November 16, 2010
Amgen just "retweeeted" this Twitter tweet from @changemakers (an Ashoka initiative, begun in 1994, that "helps advance and scale blossoming social innovations"):
"Friendly reminder: We're hosting a Patient Empowerment #SocEntChat on Nov 18 from 3-5pm EST. #health #healthcare"A Twitter "chat" can be organized by any Twitter user merely by creating a "hashtag" (ie, #SocEntChat"), scheduling it at a specific time, and promoting it. Having a hashtag is convenient because you can search Twitter for all tweets that include the hashtag. The result is content that can be useful.
I'm interested in the subject of patient empowerment because of the survey I just began ("Should Pharma Hire Online 'Patient Opinion Leaders'?"). So, naturally, the "retweet" by Amgen caught my attention.
At first, I thought that Amgen itself was hosting this Twitter chat. I am not aware of any pharma/biotech company hosting such a Twitter chat. That doesn't mean that it hasn't been done, but if it has been done, it must be a rare thing. But why?
It appears to me that a pharma-hosted Twitter chat about a disease condition would be of high interest to consumers and patients. Boehringer Ingelhiem (BI), for example, could host a COPD Twitter chat in conjunction with its DRIVE4COPD campaign. BI has a DRIVE4COPD Twitter account (@DRIVE4COPD) and has used the #4COPD hashtag (infrequently), but I haven't seen any regularly-scheduled chat (eg, #COPDChat).
There can be several reasons why I haven't seen such chats hosted by pharma companies:
- There are no guidelines from the FDA regarding how that agency will regulate Twitter chats hosted and/or "moderated" by pharma companies. A "moderated" Twitter chat is one where the discussion is lead by a person who sets the agenda (see, for example, "On Being Voted Off the Social Media Island").
- Pharma companies are concerned about being overwhelmed by adverse events that may pop up in tweets during a chat session that they host and/or moderate.
- Pharma companies are concerned about "off-label" promotion that may be made by chat participants.
- Organizing and moderating a chat requires too much effort and is too risky.
- Once you start a chat, it's very hard to control the message.
- Consumers don't really want to chat with pharma companies.
Wednesday, November 10, 2010
Yesterday, the American Medical Association (AMA) adopted a new policy on "Professionalism in the Use of Social Media" (find the press release here) According to the AMA, this policy aims at "helping physicians to maintain a positive online presence and preserve the integrity of the patient-physician relationship."
Looking over the AMA guidelines, I find that this policy, like all such policies -- including the policies of pharma companies regarding employee use of social media -- (1) was developed after the cow has left the barn (ie, many physicians are already using social media; see, for example, this recent Pharma Marketing News article: "Physician-Generated Content on Social Media Sites") and (2) has an underlying negative view of social media and physician-generated content.
The last principle, for example, states:
"Physicians must recognize that actions online and content posted may negatively affect their reputations among patients and colleagues, may have consequences for their medical careers (particularly for physicians-in-training and medical students), and can undermine public trust in the medical profession."A recent survey of physicians (see here) using social networks performed by DocCheck -- a major European physician portal and social network -- asked "Have you ever read and learned important medical information from content posted by other healthcare professionals on DocCheck, or on a similar online healthcare professional network?" Sixty-three percent (63%) said "Yes" (see chart below). Obviously, the majority of physicians learn from “physician-generated content” posted on social networks like DocCheck.
"When physicians see content posted by colleagues that appears unprofessional they have a responsibility to bring that content to the attention of the individual, so that he or she can remove it and/or take other appropriate actions. If the behavior significantly violates professional norms and the individual does not take appropriate action to resolve the situation, the physician should report the matter to appropriate authorities."What "authorities" does the AMA have in mind? The AMA? I see this as a slippery slope.
Its interesting that "dialogue" is not mentioned in the AMA policy. It's always been a tenet of social media that open discussion among users will self-regulate user-generated content and that no "official" sanctions need to be applied except in the most extreme cases.
The issue of correcting mis-information on social networks also came up as one of the questions FDA asked about pharma's use of social media (see "Should Pharma Companies Correct Drug Misinformation Posted on 3rd-Party Social Media Sites?" and "Are There Special Cases for Correcting Misinformation on Social Media Sites?"). The consensus seems to be that the correction of misinformation by pharma should not be mandated by FDA regulators. Also, people who responded to my FDA survey generally felt that information aimed at healthcare professional audiences required even less need for corrective action because of the presumed ability of these audiences to appropriately assess and filter the information.
One commenter said this about information posted by physicians:
"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."
Monday, November 08, 2010
According to a recent survey published in today's issue of Archives of Internal Medicine, 83.8 percent of physicians reported some type of relationship with the drug industry during 2009. This included nearly two-thirds (63.8 percent) who received drug samples, 70.6 percent who received food and beverages, 18.3 percent who received reimbursements and 14.1 percent who received payments for professional services. This is despite a number of efforts over the past several years that were aimed at reducing or eliminating certain types of physician-industry relationships (PIRs).
There has been some decline, however, in the percentage of physicians receiving PIRs from 2004 to 2009. "In 2004," reports the study authors, "more than 80% of physicians reported that they received food and beverages in their workplaces and 78% received drug samples. More than one third (35%) were reimbursed by companies for costs associated with professional meetings or continuing medical education (CME), and more than one-quarter (28%) received payments for consulting, speaking, or enrolling patients in clinical trials."
I plotted some of the more relevant survey results to more easily compare the 2009 data with data from 2004 (click for an enlarged view):
What's immediately striking to me is sharp drop in % of physicians receiving payments for consulting, participation on speaker bureaus and advisory boards, and for enrolling patients in clinical trials. That percent decreased from 28% in 2004 to 14% in 2009 (see last group of bars in chart above). This is in contrast to modest decreases seen for other PIRs.
It can be assumed that this is due to two factors: (1) passage of the Physician Sunshine Act as part of the Healthcare reform passed last year, and (2) the increase in the number of drug companies required by legal settlements to report payments to physicians (eg, see "Drug companies paid N.J. doctors millions to promote their products". Eventually, all pharma companies will have to report payments to physicians unless, of course, healthcare reform is repealed or scaled back by the new US Congress.
The authors of the study conclude "given that 83.8% of physicians have PIRs, it is clear that industry still has substantial financial links with the nation’s physicians. These findings support the ongoing need for a national system of disclosure of PIRs." Such a system is part of the Physician Sunshine Law, which is scheduled to go into effect in 2013. As I said above, a national disclosure of PIRs may be among the first items on the new GOP agenda's chopping block.
However, one other factor may be at play here: the decreasing number of new brand name drugs coming to market in last several years. While the authors cite cut backs in marketing due to the global financial crisis as a possible contributing factor, they do not mention that PIRs may be declining in part because of the depressed number of new drugs in the pipeline that require marketing to physicians.
Way back in 2006 I reported what I thought was a violation of PhRMA's DTC Advertising Guidelines to its Office of Accountability. I received a response TWO months later from a certain "Emily M. Johnson." It was such an unprofessional communication that I complained about it my Pharma Marketing listserv. A reader thought Emily was a "lowly, hassled intern" and she should not be blamed for the poor response. That was enough for me to invent "PhRMA Intern" (see "Adventures of PhRMA Intern!", a CLASSIC Pharma Marketing Blog post).
I imagined that PhRMA Intern was a recent graduate of an Ivy League school and might even be related to Ken Johnson, PhRMA VP of Communications.
I thought that I would never learn the TRUE identity of PhRMA Intern. Just now, however, I received this anonymous comment to another blog post:
"You peaked my curiosity about Emily Johnson. According to LinkedIn, she graduated from college in 2001, grad school in 2003, and then immediately became Director of PhRMA (no joke):Emily graduated Rutgers University in 2001 and received an MPP at Georgetown University in 2003. All during that time she was a "Director" at PhRMA. Wow, PhRMA is really liberal with its job titles! Imagine an intern still a freshman in college with the title "Director"! But why didn't she include this title in her letter to me?
"After 5 years at PhRMA, she became a Senior Associate at a PR firm. Quite a step down from Director of PhRMA."
Sunday, November 07, 2010
Damn! You mean that the odds of me lowering my cholesterol via exercise and diet are only 1 in 3?
This is the first time I have ever seen a DTC (direct to consumer) ad that so blatantly "disses" exercise and diet. At least, that's what it sounds like to me.
Older Lipitor ads featured active people -- mostly men -- such as "doctors" rowing and guys skiing or biking, etc. These ads only hinted that lifetstyle changes may not be enough. Recent ads, however, appear to be CRITICAL of those among us who are trying to change our lifestyles.
In fact, IMHO, the new Lipitor ads come very close to violating PhRMA's "Guiding Principles for Direct to Consumer Advertisements About Prescription Medicines"; especially principle #12, which states "DTC television and print advertising should include information about the availability of other options such as diet and lifestyle changes where appropriate for the advertised condition."
Yes, the new Lipitor ads do say "When healthy diet and exercise are not enough.." and "Along with diet, Lipitor....[blah, blah]. Pfizer, therefore, obeys the letter of the guidelines, but maybe not the spirit. Should I report this ad to PhRMA's "Office of Accountability?" I didn't have much luck the last time I did that (see "Adventures of PhRMA Intern!", a Pharma Marketing Blog "Classic").
The other criticism I have is in regard to the "2 out 3" claim. What's the basis for that statement of fact? I can find no reference to any data in support of that claim in the ad. The LIPITOR.com site attempts to "prove" the claim with even more unsubstantiated claims: "Only about 25% of cholesterol comes from the foods you eat. The other 75% is made by the body. Factors such as age and family history affect how much cholesterol your body makes. That’s why, for 2 out of 3 people with high cholesterol, diet and exercise alone aren’t enough and a cholesterol-lowering medicine, like LIPITOR, may be necessary."
Maybe factors such as amount of exercise ALSO affect how much cholesterol your body makes or affect how cholesterol is disposed of in your body. Maybe exercise helps stop the build up of plaque in your arteries due to high cholesterol. Etc.
Perhaps Pfizer is trying to counteract "Non-prescription Cholesterol Lowering" advice from physicians on the Internet (see here, for example) or is getting desperate as Lipitor sales continue to tank around the world (see "Pfizer Sales Lag, Hurt by Generic Lipitor, Effexor").
Whatever. I think it's the wrong message when a DTC ad leads off with "dissing" healthy lifestyle options with the phrase "Are You Kidding Yourself?" Perhaps it was meant to be just a way to capture my attention (which it did), but it SOUNDS to me like its challenging my decision to exercise and eat healthy, which directly conflicts with the advice of my doctor. Talk about interfering with the patient-doctor relationship!
Monday, November 01, 2010
There is much speculation as to when the FDA will publish its first guidance for the drug industry regarding promotion via the Internet and social media. At several recent conferences, FDA officials have stated that they expect to issue some guidance before the end of the year (2010) and will likely issue several guidances addressing specific questions that were addressed at the November 15, 2009 Part 15 public hearing (see "I Predicted It: Social Media Guidance Likely To Be Split Into Multiple Documents"). Recall that there were FIVE questions that the FDA asked the public to comment upon:
- For what online communications are manufacturers, packers, or distributors accountable?
- How can manufacturers, packers, or distributors fulfill regulatory requirements (e.g., fair balance, disclosure of indication and risk information, postmarketing submission requirements) in their Internet and social media promotion, particularly when using tools that are associated with space limitations and tools that allow for real-time communications (e.g., microblogs, mobile technology)?
- What parameters should apply to the posting of corrective information on websites controlled by third parties?
- When is the use of links appropriate?
- Questions specific to Internet adverse event reporting
Perhaps FDA will address each question in the order that they were asked. After all, they must have had a reason for numbering them 1 through 5, right? Or perhaps they are so understaffed that they will have to address the easiest question -- ie, # 4, IMHO -- first in order to keep their "promise" of issuing some guidance before the end of the year. That would be bureaucratically correct, but NOT a wise move, considering that the drug industry has pretty much addressed that issue years ago without any help from the FDA. Also, the FDA, to my knowledge, has never issued an "enforcement letter" about linking.
I predict that Q2 -- ie, the "space limitation" issue -- will be addressed first. Here's why.
First, let's look at those enforcement letters. The following chart was taken from a presentation made by FDA's Barbara Chong at the recent ePatient Connections 2010 conference (find it here).
At least 14 of the 17 2009 letters (82%) that were Internet-related concerned the issue of space limitations specifically related to search ads. That was the shot heard round the pharma world. Because of that action by FDA, pharma drastically cut back on its purchase of Google Adwords, which may account for 40% of its online promotional spend. In fact, Google -- in collaboration with the FDA -- has come up with a solution to this problem, which the FDA is sure to endorse in its upcoming guidelines. The (beta) format has even been used by at least one pharmaceutical company and the FDA did not send out any letters regarding that use (see "Is Google the New FDA?"). In other words, FDA is primed to issue guidance backed by a real world example to illustrate how to apply the guidance. It's a no-brainer as they say.
More important is the DEMAND for guidance on this issue. At the November, 2009, public hearing, the space limitation question was addressed 43 times by speakers, more than any other question (see chart below):
The same was true of comments submitted to the FDA as part of the public docket (see chart below):
In my survey of readers on this issue (see "Regulatory Solutions to Overcoming Space Limitations in Pharma Social Media Communications" and "Overcoming Space Limitations in Social Media"; use discount code 'FDA397'), which I submitted to the public docket, there were 46 comments. Unfortunately, the FDA counts this survey only once in the above chart.
In the past, waiting for guidance for Internet promotion of Rx drugs from FDA was a bit like waiting for Godot. I joked that the industry is waiting for "Goduidance." However, having guidance for addressing the space limitation issue -- especially with regard to paid search advertising -- is no joke for pharma marketers. The sooner the FDA issues that guidance and finalizes it, the better.