Health Care Provider-Consumer Perceptions-Prescription Drug-Federal Register-Dtc Advertising

Drug Ads "Coupons: Who's the Decider? The Patient, the Physician, or the FDA?

The FDA is concerned that the use of sales promotions such as free trial offers, discounts, money-back guarantees, and rebates in direct-to-consumer (DTC) prescription drug ads "artificially enhance consumers' perceptions of the product's quality" while also resulting in an "unbalanced or misleading impression of the product's safety." To test whether or not this is true, the FDA will soon start yet another study focused on Rx print ads: "Effect of Promotional Offers in Direct-to-Consumer Prescription Drug Print Advertisements on Consumer Product Perceptions" (see Federal Register Notice archived here).
[I recently posted about another planned FDA study to determine if disease awareness information in branded ads confuses consumers. See FDA Concerned About Product (eg, Lyrica) Ads That are Too "Educational"]
The history of this study is long and mysterious. I first blogged about it 2006; read "FDA, Coupons, and Sleep Aid DTC Ads." Shortly after that the Federal Register notice regarding the study was "yanked" (see "FDA Backs Down on Coupon Study"). Also, the Advertising Age and Wall Street Journal articles cited in those posts can no longer be found in the archives.
In September, 2011, however, the proposed study re-emerged in the Federal Register (here). Whatever happened between 2006 and 2011 is anybody's guess, but I assume that the Bush era FDA leaders axed the proposed study when they learned of it. By September, 2011, these people were on the way out and the door was open again to propose the study anew.
Anyhoo, I want to focus here on comments that PhRMA made in response to the proposal. Alexander Gaffney (@AlecGaffney), Health wonk and writer of news for @RAPSorg, summarized the general attitude of PhRMA (see "US Regulators Move Ahead With Planned Study on DTC Marketing"):
In its statement to FDA, PhRMA wrote it was “concerned that the study, as currently envisioned, will not yield information that is relevant to FDA’s regulatory responsibilities to ensure that DTC advertising is truthful, accurate and balanced.”
“Although the study may provide interesting information about the effect of promotional offers on consumer attitudes toward a brand,” explained PhRMA, “it likely will provide little information on whether promotional offers create or contribute to false or misleading advertising, particularly under real-world circumstances or whether additional regulatory requirements are warranted.” PhRMA: The Physician is the Decider
I dug a little deeper into PhRMA comments (here) and was surprised to learn that PhRMA's position is that "it is the physician, not the patient (my emphasis), who ultimately must decide whether the benefits of the advertised drug outweigh its risks for any particular patient." Thus, says PhRMA, "the risks of 'misperceptions' ... should be even lower [PhRMA's emphasis] for prescription drugs than for experience goods [i.e., a product or service where product characteristics, such as quality or price are difficult to observe in advance, but these characteristics can be ascertained upon consumption] because any potential misperception, of necessity, will be quickly corrected prior to use through consultation with the patient's treating physician."
This is a very paternalistic POV in this day and age of social media and patient empowerment. Actually, it is the old "learned intermediary" defense that the drug industry often raises (in the past, less so these days) to shield itself from blame when things go wrong.
FDA must respond to comments submitted, but I couldn't find a direct response to PhRMA's comments cited above. I did find, however, the following comments and FDA's response that addressed the issue of the patient-physician relationship generally:
(Comment 22) Two comments mentioned that the study does not assess how consumer perceptions of product risks and benefits are translated into a discussion with their health care provider. read more..

Prescription Drug-Medical Providers-Alert Systems-Fda Drug

FDA fails to send alerts on 20% of Class I drug recalls

The FDA hasn't always been on top of notifications to medical providers about the most serious drug recalls, a study has found. Between 2004 and 2011, nearly 20% of the Class I drugs recalls were not included in either of the agency's two alert systems, reports Reuters. Class I drugs include those that can cause "serious adverse health consequences or death." Over the 8 years, Joshua Gagne of Brigham and Women's Hospital in Boston and other researchers counted more than 1,700 FDA drug recalls and found only 91 were serious Class I recalls. The agency sent out 2,900 announcements through the Recall Alert System but included alerts for just 55 of the 91 Class I recalls. Its MedWatch system picked up another 18 of the remaining recalls, but 18 more, or 20% of the Class I recalls, were not reported through either system, the study found. The researchers acknowledge they couldn't document any adverse effects related to the failure and also that FDA has made strides in the last year. They suggest, however, that the agency set up a system specific to Class I drugs. The problem of recalls is complex. A recent report found that last year there were 55 prescription drug recalls and 14 recalls related to OTC products, but the OTC recalls involved millions more products. Story | More read more..

source:http://www.fiercepharmamanufacturing.com/

Prescription Drugs-Heart Disease-Heart Attack-Percentage

Drugs are Losing the Battle Against Heart Disease. Here's Why.

The percentage of the U.S. population taking at least one prescription drug during the past 30 days increased from 38% in 1988–1994 to 48% in 2005–2008. During the same period, the percentage taking three or more prescription drugs nearly doubled, from 11% to 21%, and the percentage taking five or more drugs increased from 4% to 11%. These data come from the CDC "Health, Unites States, 2011" report (find it here).
Meanwhile, the prevalence of heart disease, which is the leading cause of death in the U.S., remained steady from 1999–2000 to 2009–2010 among adult women in all age groups, and among men 45–74 years of age. Among men 75 years of age and over, prevalence rose from 39% in 1999–2000 to 45% in 2009–2010.
There goes my rationale for taking statins to lower my risk of heart attack! It seems that the drug industry is not as successful in improving our health as it claims to be.
And new drugs aimed at lowering the risk for heart disease currently being developed may be effective in achieving "surrogate endpoints" in clinical trials but not effective in reducing risk.
That was the takeaway from a new study published online recently in The Lancet. That study provided evidence that increasing the level of HDL ("good cholesterol") does not lead to less risk for heart disease (see "HDL hypothesis is on the ropes right now").
That's not good news for companies that are actively developing and testing drugs that raise HDL -- even if these drugs succeed in that goal they are not likely to help prevent heart disease.
There's lots of other interesting data in the CDC report. I've gathered my favorite charts into the infographic shown here (click here for an enlarged view). read more..

Prescription Drug-Fda Regulations-Public Hearing-Social Media-FDA

A Cautionary Tale for Anyone Expecting FDA Social Media Guidelines Any Time Soon

If you think waiting over two years for FDA to issue guidelines it promised for regulation of "Promotion of Prescription Drug Products Using Social Media Tools," then you should take a look at the following timeline and weep.
This timeline documents the major steps in FDA's process of developing guidance for direct to consumer television (DTC) and radio ads; ie, "standards that would be considered in determining whether the major statement in direct-to-consumer television and radio advertisements relating to the side effects and contraindications of an advertised prescription drug intended for use by humans is presented in a clear, conspicuous, and neutral manner":

• 1 November 2005: FDA convenes a 2-day public hearing to discuss the issue (see "FDA DTC Hearings: Snippets from Day 1" and "DTC Pros and Cons Presented at Public Hearing"). Sound familiar?


• 21 August 2007: FDA announces it will conduct a study of "consumer evaluations of variations in communicating risk information in direct-to-consumer (DTC) prescription drug broadcast advertisements." It opens a 90-day period to submit comments regarding this study. This study used the latest cognitive science technique called Affect Misattribution Procedure (AMP), in which participants are asked not to judge the TV ads' imagery directly, but to judge whether or not a Chinese character shown to them afterward is positive or negative. I suggested it NOT use Chinese characters because that would be discriminatory, but they did not listen to me (see "FDA at a Mall Near You: The Manchurian Connection"). With regard to social media guidelines, the FDA has also announced it will do some studies before issuing guidance (see "FDA's Proposed Web Study Will Further Delay Social Media Guidelines"). Deja vu all over again!


• 29 March 2010: FDA finally publishes the draft guidance, more than 4 years after the public hearing (see Federal register ref: 75 FR 15376). FDA was goosed along by an act of Congress: the Food and Drug Administration Amendments Act of 2007 (FDAAA), which required that the major statement in DTC television or radio advertisements (or ads) relating to the side effects and contraindications of an advertised prescription drug intended for use by humans be presented in a clear, conspicuous, and neutral manner. FDA was forced into RULEMAKING mode rather than GUIDANCE mode, which is how the pharma industry wants the agency to approach the regulation social media drug promotion as well (see "Pfizer Asks for New FDA Regulations, Not Guidance, for Social Media").


• June 2011: FDA published an executive summary of a study of the methodology of the AMP study cited above entitled "A Supplementary Test of Distraction in DTC Advertising Using an Implicit Measure, The Affect Misattribution Procedure" (find it here). Maybe FDA read my comments after all!


• 27 January 2012: FDA announced that it added a document to the docket for the proposed rulemaking concerning a study entitled: "Experimental Evaluation of the Impact of Distraction on Consumer Understanding of Risk and Benefit Information in Direct-to-Consumer Prescription Drug Television Advertisements" (Distraction Study; see Docket No. FDA–2009–N–0582). This document reopened the comment period (extending the deadline to February 27, 2012) for the rulemaking proceeding to allow an opportunity for comment on the study as it relates to the proposed standards. Way back during the public hearing in 2005 I was unimpressed by research claiming that TV drug ads were designed to "distract" viewers from reading the fair balance (see op cit and "Ruth Day and the Bees Repeat Performance at House DTC Hearing" for an update on that).


• 23 March 2012: FDA reopens the comment period for a second time "in response to a request for more time to submit comments to the Agency." The new comment period will expire on April 9, 2012. According to the FDA, the "Pharmaceut read more..

Ncaa Basketball Tournament-Pharma Dtc Tv Advertising-Prescription Drug-Drug Ads

Pharma DTC TV Advertising Is a Joke. Seriously.

No wonder CBS refused to run the following "Stoogesta" ad during the NCAA basketball tournament. According to Deadline, network execs were concerned because the spoof, which promotes the forthcoming “The Three Stooges” movie, makes "light of prescription drug ads."
I've seen some pretty funny spoofs of drug DTC ads in my time (eg, see "ADHD Boy"), but this is the best I have ever seen. It convinced me to visit my movie theater & ask for an Rx of silly!
I imagine that pharmaceutical advertisers sent a clear message to CBS that they did NOT find the spoof funny. Rx drugs, after all, are serious and should not be made "light of."
However, it's not the drugs that are being spoofed. It is the drug advertisers who have rolled out the same formulaic DTC TV ads for years and years. Even kids think most of these ads are a joke.
Will the formula ever change? I don't think so. Here's why.
One of the funniest lines in the spoof is "Three in 6 billion people are afflicted by Stoogation (?), a disorder that causes the brain to ricochet and bounce..." That's just slightly more outrageous than some claims made in real drug ads about the prevalence of some "disease" you never heard of before.
I've commented on the topic of DTC ads making outrageous disease prevalence claims before (see "Disease Awareness or 'Disease Mongering'?", for example). In many cases, it is absolutely necessary for drug ads to make such claims to justify the millions of dollars spent on mass media TV ads to reach the "three in 6 billion" people who may suffer from the condition advertised.
So, the tradition of "making light of drug ads" will live on as long as advertising agencies and TV networks rake in millions of dollars to air ads that would be better off targeted to the truly appropriate audience.
BTW, the NCAA basketball tournament audience is PERFECT for the Stoogesta ad! But the ad that was chosen to run in its place is totally wrong; that ad spoofs Christianity! Where's the religious right when you need them? read more..

Food And Drug Administration-Television Advertisement-Prescription Drugs-Warning Letter

A Loophole (?) in New FDA Guidance on Pre-Dissemination Review of TV Direct-to-Consumer Ads

On September 27, 2007, President Bush signed into law the Food and Drug Administration Amendments Act of 2007 (FDAAA), which gives FDA the authority to ". . . require the submission of any television advertisement for a drug . . . not later than 45 days before dissemination of the television advertisement." The notice of issuance of "Draft Guidance for Industry Direct-to-Consumer Television Advertisements — FDAAA DTC Television Ad Pre-Dissemination Review Program" was published today in the Federal register (see "Draft FDA Guidance on PreDissemination Review of TV Direct-to-Consumer Ads").
Before I get to the "loophole," here's a summary of the guidance.
Up until now, the FDA allowed the VOLUNTARY submission of TV ads for review prior to airing, but did not require it. The draft guidance details which type of TV ads REQUIRE approval prior to "dissemination," how long it will take FDA to review these ads and get back to the sponsor (45 days), and what the sponsor can do if the FDA does NOT meet the 45-day deadline. Of course, it also mentions CRIMINAL and CIVIL MONETARY penalties that may be sought by the FDA for violations.
Which Ads Will Require "Pre-dissemination" Review?
The Agency intends to require sponsors to submit TV ads for pre-dissemination review in the following categories:

• Category 1: The initial TV ad for any prescription drug or the initial TV ad for a new or expanded approved indication for any prescription drug 
• Category 2: All TV ads for prescription drugs subject to a Risk Evaluation and Mitigation Strategy (REMS) with elements to assure safe use (see section 505-1(f) of the FD&C Act) 
• Category 3: All TV ads for Schedule II controlled substances 
• Category 4: The first TV ad for a prescription drug following a safety labeling update that affects the Boxed Warning, Contraindications, or Warnings & Precautions section of its labeling 
• Category 5: The first TV ad for a prescription drug following the receipt by the sponsor of an enforcement letter (i.e. a Warning or untitled letter) for that product that either cites a TV ad or causes a TV ad to be discontinued because the TV ad contained violations similar to the ones cited in the enforcement letter  
• Category 6: Any TV ad that is otherwise identified by FDA as subject to the pre-dissemination review provision

"Specifically, these categories allow the Agency to review and provide comments on TV ads for prescription drugs with particularly serious risks," says the FDA
Regarding the 45-Day Review Period, FDA says:
"Once the 45-day review time has elapsed, there is no specific legal consequence resulting from disseminating the proposed TV ad without waiting for FDA’s comments. However, once an ad is disseminated, the sponsor is at risk of enforcement action if the ad violates the FD&C Act and implementing FDA regulations."
That is, if the FDA misses its deadline, the situation reverts back to what is the current practice -- air the commercial and perhaps suffer the consequences, which could be nothing more than a warning letter, but may also require the sponsor to air a correction.
What Exactly Will the FDA Review?
In the past, FDA has primarily reviewed TV Ad storyboards, which are graphical representations of key scenes in the ad with dialog included. Storyboards are blueprints for production and are created BEFORE any video production has begun. Now, however, FDA requires a video of the TV ad to be submitted to fulfill the submission requirements. Only after the video is submitted will the 45-day review clock start running.
"FDA cannot provide final comments on the acceptability of a TV ad without viewing a final recorded version in its entirety. FDA understands that some sponsors may wish to receive comments from the Agency before producing a final recorded version of the ad. In such situations, sponsors can submit a pre-dissemination review packag read more..