FDA's decision to block approval of OTC status for the Plan B contraceptive is rapidly becoming the center of an FDA controversy that has all the earmarks of a Watergate conspiracy.
At the center of the controversy is a report by the non-partisan Government Accountability Office (GAO) released yesterday to Congress. The report claims that top officials at the Food and Drug Administration decided to block over-the-counter sales of the Plan B contraceptive months before completing their review of the application in 2004.
Two FDA commissioners appointed by president Bush -- Mark B. McClellan and Lester M. Crawford -- were allegedly involved in the decision to bar Barr's Plan B OTC conversion. Both commissioners resigned after very short terms. According to a story in the NY Times, the FDA deleted or threw out all of McClellan's e-mail and written correspondence on the subject (reminds me of Nixon's lost section of tape) and Crawford has conveniently refused to cooperate with the GAO inquiry. And we all though Lester left town because of financial conflicts of interest! Sure.
According to the Times story, the GAO report called FDA's decision on Plan B unusual in several respects:
Top agency officials were deeply involved in the decision, which was "very, very rare," a top F.D.A. review official told investigators. The officials' decision to ignore the recommendation of an independent advisory committee as well as the agency's own scientific review staff was unprecedented, the report found. And a top official's "novel" rationale for rejecting the application contradicted past agency practices, it concluded.
In the 10 years prior to the rejection of Plan B OTC status, when the FDA reviewed 23 applications to switch drugs from Rx to OTC, the FDA never went against the advice of its own advisory committee as it did with Plan B.
The FDA's "novel" rationale for rejecting Plan B was explained by Dr. Steven Galston, the acting director of the FDA's Center for Drug Evaluation and Research:
Dr. Galston said younger teenagers might act differently than older ones and might engage in riskier sex if they knew an emergency contraceptive was easily available. The company needed more data to ensure that this was not true, he said.
In the rejection letter, Galston suggested Barr could get approval if it would sell the drug "behind-the-counter," making it easily available only to women 16 and older, with younger women still needing a prescription.
Barr chose that option in a new application filed in July 2004. FDA rules required it to issue a decision by January, 2005, but it has delayed doing so indefinitely. Soon after the FDA waffled and opened a 60-day comment period, Susan Wood resigned from her position as FDA assistant commissioner for women's health in protest of the Plan B decision.
"I can no longer serve as staff when scientific and clinical evidence, fully evaluated and recommended for approval by the professional staff here, has been overruled," said Wood.
Matthew Holt over at The Health Care Blog, claims that Plan B FDAgate "is only one small battle in the war to keep the creationists and fundamentalists loons outside of science. A battle that weÂ’ve lost."
Watch out Matt! Pat Robinson may curse you as he cursed a town in Pennsylvania for exercising their democratic right to vote out creationists on their school board. Or he may call for your assassination.
Regardless of your views on contraception, abortions, and evolution, it's a sad day when government officials subvert the checks and balances built into our system of government that prevent dictatorships. If FDA commissioners can overrule their staffs and later cover up and refuse to account for their actions, then the next step is a system based on Commissars.
The following topics will be covered in depth in the upcoming November issue of Pharma Marketing News. Access the preview online at www.pharma-mkting.com/news/PMNissue410OnlinePreview.htm.
DTC Pros and Cons Presented at FDA Hearing
ePeople are polite in Washington, DC. They don’t rush and knock you down in the Metro (subway) like people do in NYC. Similarly, FDA staffers and presenters at the recent public hearing on DTC were very polite too. The nice FDA people asked nice questions and the nice presenters, for the most part, didn’t blast the FDA for not doing anything to reign in DTC or for doing too much. Presenters were more or less evenly divided as to whether they supported DTC or were against it.
This article summarizes the main points, both pro and con, made by presenters at this meeting and includes commentary from expert members of the Pharms Marketing Roundtable, which met to discuss the issues raised at this hearing.
If you are interested in joining the EXCLUSIVE Pharma Marketing Roundtable, click here for an application form. Members include professionals working within pharmaceutical companies as well as in advertising agencies, medical communications companies, and other pharmaceutical vendor companies. The PMN Roundtable meets periodically via conference call.
For a review of a few of the summaries made at the FDA hearing, see FDA DTC Hearings: Snippets from Day 1 and FDA DTC Hearings Day 2.
Predictive Physician Marketing
According to some experts, the pharmaceutical industry has only itself to blame for limited physician access and two minute sales calls (see "Marketing's Role in Limiting Physician Access and What to Do About It," Increase Physician Access and Detailing Effectiveness Special PMN Supplement).
Creating product detail pieces and training representatives on the use of new materials represents a considerable marketing investment. It would be extremely valuable, therefore, to be able to predict how well a campaign will be before it is launched.
Now there is a method proven to predict the success of a campaign prior to launch. The ProSigma™ Detail Model created by TargetRx, a marketing information services company located in Horsham, PA, helps pharmaceutical marketers develop the best detail and detail piece to drive prescribing behavior.
GSK Strikes Back with a Grassroots Campaign
Mike Pucci, Vice President of External Affairs at GlaxoSmithKline (GSK), is a man with a mission, which is to get the word out about the good that the pharmaceutical industry is doing (or, as Pucci expressed his goal: to "Restore the reputation of the industry by communicating the value of our products, our research and our hope for the future"). He spoke recently at an industry Forum on Customer Relationship Management (CRM) held in Princeton, New Jersey.
For more on this topic, see a previous post to Pharma Marketing Blog (The Empire Strikes Back).
Global Digital Asset Brand Management
As pharmaceutical marketers turn toward the Internet, the demand for digital "rich media"-streaming video and audio, Flash animation, Java applets, streaming video and interactivity-is growing rapidly. There is a need to leverage this rich media content across brands and marketing campaigns on a global scale, but analysts estimate as much as 30 percent of all content is lost or misplaced annually, resulting in huge cost burdens for companies to recreate lost assets. This article is a review of ClearStory Systems' ActiveMedia, which is an example of a next-generation digital asset management (DAM) solution for managing rich media.
Sales Rep Assessment: Shoot the Messenger, the Message, or Both?
Getting sales representatives in front of doctors is still the most effective way to present the "story" of a drug, according to Hank McKinnell, CEO of Pfizer. The story is the marketing messages contained in the detail aid and talking points that sales reps use when calling upon physicians. Getting the story right and delivering it effectively is more important than ever and it is crucial that sales reps get proper training. This article is a review of Metamorph, Inc.'s methodology of using specially trained physicians to assess and validate sales strategy, marketing messages and sales aids of pharmaceutical companies based on real-time calls with reps using a standardised set of data points.
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Patrick Kelly, President of Pfizer US Pharmaceuticals, who testified at the recent FDA public hearing on DTC, announced that Pfizer has allocated a portion of their media budget a financial amount "equivalent to one major medicine" to address general public health as a "stand-alone brand" without mentioning any drug brand. Part of this sum may be used to develop a special category of unbranded ads: Help-seeking ads or unbranded disease-awareness ads. (This is mentioned in Pfizer's DTC Pledge (see "Pfizer DTC Pledge: ED is Litmus Test").
Disease-awareness ads are not subject to the disclosure requirements of the Federal Food, Drug, and Cosmetics Act and FDA regulations. These ads are communications disseminated to consumers or health care practitioners that discuss a particular disease or health condition, but do not mention any specific drug or device or make any representation or suggestion concerning a particular drug or device.
Even though Pfizer -- and other pharma companies -- may be spending more of their media budget in the future on disease-awareness ads, they don't believe these ads are as effective as branded DTC in driving consumers to seek help.
According to Kelly, "general disease-awareness and help-seeking ads do not drive patients to the doctor to anywhere near the degree that information about a solution or a potential solution will." This finding is "not well-understood," said Kelly.
"What we have found," Kelly said, "is that if your express just that you should be aware that there is a medical condition or a disease that you should worry about, it doesn't generate as much action as if you then say there might be potential solutions that you should consult with your provider about. So it is the other connection that is important for motivating action."
Why don't unbranded ads work?
First, Kelly did not identify any scientific analysis of this problem or any data to support his contention that branded ads are better motivators than unbranded ads. He may be referring to real world experience at Pfizer -- internal data that we don't have access to.
This issue was discussed recently on the Pharma Marketing Online Discussion Forum and I quote the discussion thread here. David, who works at a marketing research firm, opened the discussion:
Having developed and tested many OTC and Rx DTC ads, I believe I can provide some insight as to why unbranded disease awareness ads do not generate response and how to improve these ads.
The reason that consumers respond to branded ads more than unbranded disease awareness ads is primarily not because of a branding effect, although branding is powerful in its own right. Consumers do not respond to a disease awareness ad because they are being made more aware and knowledgeable about a "problem" and less aware and knowledgeable about a "solution" to address that problem. Simply: Who in their right mind wants to know about having a problem for which there is no solution?
So disease awareness ads to get better response, they must discuss availability solutions in greater depth and tangibility without mentioning the brand as well as stay within FDA regulations. This same reasoning is also why health promotion is always more effective than health education. In a consumer driven market, consumers simply want solutions, not problems.
Sounds reasonable. Note that David leaves the door open to how disease awareness ads can be improved without mentioning specific products. James, who works at an interactive ad agency, had this to say:
I think your point is a good one: many historical condition ads have missed the mark for various strategic/tactical reasons. That said, I'm personally not yet willing to temper my current enthusiasm for *good* condition advertising just because many (most?) executions to-date have been ill-conceived or poorly executed.
Good condition advertising, like all effective advertising, doesn't stop with the highlighting of a problem or unmet need ... it has to point to a solution and have a call-to-action. It also has to be distinctive, engaging, and relevant to your target. Shame on clients and agencies who lose sight of these old advertising truths as they move out of their branded ad comfort zone!
As a possible best practice, consider GSK's television ads for their condition website, diabetes.com. If you've seen them, it's a compelling (frightening?) narrative of a middle-aged man talking candidly about he failed to take his diabetes seriously. As the commercial unfolds, it's clear that something isn't "just right" with him and his face. My heart skipped a beat as he proceeded to end the commercial by picking up a white cane and shuffling from the room. Yikes.
Ending here would have been a mistake, so I was pleased to see the clear call-to-action: take suspected or diagnosed diabetes seriously, get informed about how to take care of yourself, and see a physician soon if you're at risk. There's hope but you need to take the first few steps.
I'm connected to another unbranded campaign currently in-market for the GSK/ALA "Asthma Control Test" and can't comment on its effectiveness, but perhaps some of you have seen the so-called "Stethoscope" ads and have a POV.
To which David replied:
I agree, there is no reason why condition advertising cannot be improved greatly. As I pointed out, there needs to be solutions conveyed in this advertising so that it is not problem-only advertising. However, here is where the missing branding effect needs to be addressed. Branding, or naming, has a very powerful effect on solutions. Naming gives identity and reality to products and services, and becomes an anchor for advertising communication to keep building meaning and equity around.
But as you point out below, in the GSK ad the call to action is to get diagnosed of the PROBLEM. Getting informed about how to take care of yourself is not necessarily perceived as a solution. Compared to an easy-to-swallow magic pill, taking care of yourself could instead be seen as a difficult on-going challenge of lifestyle change for the rest of one's life, requiring change, giving up some things you like to do, having to exercise and work out, going to a managed care doctor who is very short an unsympathetic and possibly even frightening that the doctor may discover even more serious problems.
I think pharma and managed care should try to see how consumers actually see and experience the healthcare world, not be so immersed in their own beliefs of doing good. I'm not surprised that pharma has an image problem. There is a huge scientific literacy problem in the US. Consumers see drugs as "chemicals" and if a patient has hypertension or Hyperlipidemia, they see the prospect of having to take drugs the rest of their lives as becoming dependent on drugs. On top of it, approved drugs are often latter discovered after widespread usage to have serious and even fatal side effects. No wonder there is a compliance problem!
Instead of 30 and 60 second blurbs, I have often thought that pharma should invest in 30 or 60 minute infomercials where they do real patient education and even an integrated disease management program that is supported by interactive call centers and websites. Unfortunately, morbidity and mortality of the top 6 leading US causes of death can improved significantly with lifestyle changes. But lifestyle change is not easy to accomplish.
I agree with many of the points made by David and James. I would add that pharmaceutical companies, mainly through relentless product-branded "solution" ads to consumers, is the major culprit in fostering the "magic-pill" solution preference among Americans.
Some DTC ads (branded or not) mention lifestyle changes as alternatives to drugs, but they do so only fleetingly. They don't say, for example, that if you are overweight and lose X number of pounds your cadiovascular risk will be lessened by Y%. This is the kind of "solution" message, if repeated often enough (as often as the "take a pill" message is repeated), people might find motivating.
The second day of the FDA hearings on DTC was essentially more of the same as the first day. There were, however, a few nuggets here and there that I feel are "blogworthy" enough to include here. I left early, so I can only cover the morning presentations.
Alex Sugarman-Brozan, representing a group called Prescription Access Litigation, looked like a radical on the program guide and he did not disappoint. His group claims to represent consumers in class action lawsuits against pharmaceutical companies and targets deceptive marketing. He was against any DTC advertising that did not include the complete product labeling. This includes TV ads, which the FDA says are OK without the full labelling as long as "adequate provision" was made for consumers to access the labeling in other media -- i.e., print and the Internet. In other words, Mr. Sugarman-Brozan (I hate people with 2 last names! Not really. I just hate wasting my time on unnecessary typing!) is against the adequate provision regulation that allows DTC on TV and radio.
Pre-Approval of DTCA by FDA
On the other hand, SB made several interesting observations that should be taken seriously, one of which involves pre-approval of DTC promotions by FDA. Pre-approval has been recommended by PhRMA in its voluntary guidelines and several pharma companies pledged to submit all their DTC ads to FDA before running them (Astrazeneca on Tuesday "proposed a mandatory requirement for pharmaceutical companies to submit all direct-to-consumer advertising to the U.S. Food and Drug Administration for review prior to its use," according to a Reuters news story).
SB's observation is that the FDA has 40 staff members to view all drug promotions, including DTC and promotions to health care professionals. SB claimed there were 53,000 such promotions in 2004. That means each FDA reviewer would need to review 5.5 promotions per day. This, of course, would be impossible. Although these numbers may be inflated (e.g., include all promotions, not just DTC), the FDA would be hard-pressed to review all DTC promotions before airing in a timely fashion. To do so would require additional staff and funding. Another presenter suggested that a new type of "users fee" be imposed on the industry to cover this extra expense. In other words, these critics would set up a DTC promotion approval regime similar to the drug approval process. Yeah, that'll happen! I expect the drug industry would like that as much as the drug approval process (think DELAY; this is a major sore point with the industry. According to FDLI SmartBrief,"Pharmaceutical firms now need an average 8.5 years to move a new product through clinical and approval phases, according to a study by the Tufts Center for the Study of Drug Development.")
Nevertheless, SB recommended that FDA review all DTCA, including broadcast, print and online ads. He also recommended the following:
FDA should seek power to impose civil monetary penalties. He criticized the current method of issuing warning letters and likened it to British Bobbies shouting out "Stop! Or I'll shout stop again" as they pursue bad guys with no threat of force. The audience had a good laugh at that one.
[AN ASIDE: Generally, I found DTC critics much more entertaining at the hearing than supporters. They were lively presenters and often had multimedia accompaniment. The supports were dry and boring for the most part. Jeez! Why do they leave all their marketing skills at the office! Maybe if they were more entertaining and even had a few sound bites like the above I would write about them in this blog more often. However, it is not my goal here to be balanced and present all views no matter how entertaining they may be.]
End FDA Chief Counsel review of all enforcement letters. Although SB doesn't think FDA warning letters are effective, he nevertheless suggested that these letters not be impeded by FDA's chief counsel review. This issue was discussed in a previous post to this blog (see "WLF Watches FDA Watching Drug Ads").
Regulate Disease Awareness Ads. There was much discussion of this type of promotion, which is non-branded. Most of the discussion was about how effective these ads are in driving people to seek medical help -- a key benefit of branded DTC cited by proponents (J. Patrick Kelly from Pfizer reported on a study that claimed to show that branded DTC ads were much more effective at getting people to see their doctors than non-branded disease awareness-type ads. FDA referred to this study over and over again when questioning critics, raising it's conclusion to the level of dogma or conventional wisdom. I have not yet examined the study but at least one critic testifying at the hearing dismissed it).
SB suggested, however, that the disease awareness ad may become the "new reminder ad" and serves merely to drive consumers to branded promotions in other media such as the Internet. He cited a Pfizer TV ad on depression, which did not mention any product name but urged viewers to visit the web site depressionhelp.com, which is clearly a site that promotes Zoloft, Pfizer's antidepressant drug. On the site, Lorraine Bracco, the actor who played a psychiatrist on the HBO show The Sopranos, says "[my doctor] put me on Zoloft (link to zoloft.com). I was also on therapy... And let me tell you something...getting treatment was the best thing I've ever done for myself."
[I include her photo to add some visual interest. She looks great, huh? The photo must have been taken a long time ago, because I saw her on a recent Law and Order show and she looked really fat and ugly! (I should talk!) Maybe she wore a fat suit on the show and it is a recent photo and she went on the South Beach diet and shot up a lot of Botox after the show. Nah! I think it's an old photo. I wish I had more photos of me when I was younger! If only I knew that I'd be a blog celebrity way back then!]
SB proposed that such disease awareness ads -- where there is a link to branded promotion on the Internet -- should be regulated by the FDA as if they were product ads, The two, in other words, should be regulated as one ad. This is a quite interesting idea and bears looking into some more.
But not now, not here. I have to get to work. More on the FDA DTC hearing later.
I am in Washington, DC attending the FDA public hearing on DTC. I will try to summarize a few of the more interesting presentations here. Later, I will cover the proceedings in more detail in the Pharma Marketing News newsletter.
People are polite in Washington, DC. They don’t rush and knock you down in the Metro (subway) like people do in NYC. Similarly, FDA people and presenters at today’s public hearing on DTC were very polite too. The nice FDA people asked nice questions and the nice presenters, for the most part, didn’t blast the FDA for not doing anything to reign in DTC.
[There was one exception: Lisa Van Syckel from drugawareness.org made an impassioned presentation that claimed drugs like Paxil and Prozac were responsible for the deaths of many adolescents. The video she presented was very disturbing and it suggested that the FDA rejected evidence and refused to do anything about these drugs.]
I rated each presenter as to whether they supported DTC or were against it. By my estimate, the presenters were evenly divided: 50% for and 50% against. Good balance FDA!
Anyway, the first panel, for the most part presented results from cognitive and linguistic studies. These studies measured readability, etc. and were designed to quantify “fair balance” in ads; i.e., presentation of risk and side effect information commensurate with benefit information. Most confirmed the obvious like: risk information in print DTC requires a reading level two grades higher than that required for the benefit information.
A study reported by Ruth Day of Duke University, discovered that the bee in the Nasonex TV commercial beat its wings furiously when risk information was being presented but was still when benefit information was presented. Day claimed that the beating wings divert viewers’ attention from the risk information. Pretty neat, eh?
How devious DTC advertisers are! I never thought they were clever enough to employ such nefarious devices to subvert the fair balance guidelines of the FDA, which never had a clue!
Notwithstanding the credibility of her studies, Day’s main point was this: In TV and print DTC ads “risk information is physically present but functionally absent.” There’s a sound bite for you!
Lewis Glinert of Dartmouth was a very witty and droll presenter on the linguistic merits of DTC advertising. He stated, for example, “consumers should not expect to find any logic in ads.” He also claimed that DTC ads have many touches of “postmodernist irony.” He didn’t explain what that meant nor did he offer any examples. Too bad.
Gilbert threw out some linguistic terms like “fragmatics” and cited the phrase “ask your doctor” as an example. It all depends on what you mean by the word “ask,” which according to Gilbert has a “web of meanings.” Who knew drug advertisers had such a depth of linguistic knowledge? Anyway, the FDA promised to look into this.
A few panelists presented convincing data that showed that DTC was effective in people to seek medical care. One study presented by Andrew Kleit of Penn State also claimed to show that DTC was “efficient,” meaning that it drove the right people – those who would benefit the most from the advertised treatment – to seek help better than those who were not the best candidates.
On the other hand, Micelle Spence of Kaiser Permanente cited her organization did that showed patients who saw a COX 2 ad and asked their docs about the drug were significantly more likely to be prescribed the drug even though clinical guidelines recommended other NSAIDs for these patients. Of course, the guidelines were based on cost-effectiveness rather than clinical data. Spence concluded that many new drugs promoted by DTC demonstrate a “small benefit for a large fee.”
A couple of other interesting tidbits before I call it quits for the night:
Celebrities in advertising: Abby Mehta of Gallup and Robinson did a study of Celebrities in DTC Advertising financed by Pfizer. She found that although ads featuring celebrities were more effective at “breaking through the clutter” and were more “likeable” by consumers, the ads generally were not more informative or believable and may or may not motivate consumers to seek treatment (it depends on the condition).
Power of images: Diana Zuckerman of the National Research Center for Women & Families suggested that the power of DTC is in the images, not the words. The positive benefit images are so powerful, she contended, that the images defeat any attempt at fair balance. This left the FDA wondering how it would regulate images to achieve fair balance – how could they measure the effect? Zuckerman suggested that the only way to guarantee fair balance is to do away with images in ads. Yeah, that could happen.
Don’t ask me what the likely outcome of this hearing will be viz-a-viz possible new regulations from the FDA. All I can point to is the tenor of the questions that the FDA asked as a hint to where they may be going.
Clearly fair balance and better presentation of risk information is of great interest to the FDA. With so many nuances like the use of certain words and phrases, images, font size, placement, etc. that affect fair balance, it would require a great deal of micromanaging the creative process to regulate DTC ads under a new regulatory regime focused on balancing benefits and risks. It may be easier to place a moratorium on DTC advertising of new drugs until doctors and the public become more familiar with side effects. After all, many presenters – especially representatives of drug companies – are careful to point out that DTC is only one source of information about drugs and not even the top source. A few months without DTC, therefore, would not limit consumers’ knowledge of available treatments nor adversely affect their motivation to seek treatment.
