Last year, the FDA acknowledged the difficulty in policing advertisements aimed at healthcare professionals and consumers by creating its 'Bad Ad' program, which the agency recently maintained is having a positive effect (read here). But just how bad were pharmaceutical ads before the FDA launched this program?
To gain some clarity, researchers examined 192 pharmaceutical ads that ran in biomedical journals in November 2008 - less than two years before the 'Bad Ad' program began - and found that only 18 percent were compliant with FDA guidelines. And more than half failed to quantify serious risks, including death, according to their study, which was published PLoS One.
To be more specific, of those 192 ads, which were promoting 82 unique meds, only 15 fully adhered to all 20 FDA Prescription Drug Advertising Guidelines (read here). Meanwhile, 57.8 percent of the ads did not quantify serious risks, 48.2 percent lacked verifiable references and 28.9 percent failed to present adequate efficacy quantification.
Many advertised drugs in the sample presented potential risks - 31 contain black box warnings and 33 place patients at risk for death or serious morbidity. And 36 ads, by the way, referenced “data on file” and 40 lacked verifiable references, due either to an absence of any references or to the presence of references only to data on file or the product’s package insert, the researchers found.
Which journals qualified for their review? The Journal of the National Cancer Institute; JAMA; Gastroenterology; Annals of Internal Medicine; Archives of General Psychiatry; Blood; Circulation; Hepatology; Journal of the American College of Cardiology; Journal of Clinical Oncology, and The New England Journal of Medicine (n=35).
Ads were considered adherent if they contained none of the 21 features used by FDA to classify ads as misleading non-adherent if they contained one or more of the features used by FDA to classify ads as misleading, and possibly non-adherent if there were no features clearly defining a misleading ad but at least 1 of those items for which information was incomplete, the researchers wrote.
The researchers found statistically significant differences in non-adherence rates to FDA guidelines by item content. Nine ads, or 10.8 percent, were non-adherent to at least one FDA item focused on safety, while 18, or 21.7 percent of ads, were non-adherent to at least one FDA item focused on efficacy and 16 ads were non-adherent to at least one item focused on references.
"Advertising is a form of free speech and is a constitutionally protected right of industry," the researchers write. But, "current FDA guidelines are subjective and challenging to enforce and do not emphasize transparency and the inclusion of basic information relevant to prescribing. Increased enforcement of the current regulations would help improve advertisements, but the subjectivity of the guidelines presents a substantial barrier."
"The limited resources of the FDA’s Division of Drug Marketing and Advertising are a major barrier to successful regulation of the pharmaceutical industry’s multi-billion dollar marketing budget,” Deborah Korenstein, lead author of the study and associate professor of Medicine at Mount Sinai School of Medicine, says in a statement (here is the complete study).
21 Comments
Simple fix. Require preclearance of all ads with DDMAC, just like with initial promotional material. I favor the proposal of prohibiting all forms of drug advertising for the first year psot approval. This would give the sponsor enough time to develop all of its material, submit to FDA, then get approval within that first year.
Does DDMAC believe that a product's package insert, which is approved by FDA & the basis for the product's availability, is not a "verifiable reference"? That seems...strange.
Salient, my experience working with Marketing over the years has shown the these folks regard package inserts like some people regard SOP'S, there mostly to collect dust. Speaking of "verifiable reference", much of the time the only reference on a drug ad will be "data on file". Beyond FDA nobody gets to see the data that served as the basis for the ad.
"There's gambling right here in River City!!"
Duuuh! Meanwhile, sun will set in the West; news at 11.
Just an attempt at humor - suprising, this is NOT!
original-Surely DDMAC would consider the PI a verifiable reference, which was my point. How marketing looks at it is irrelevant to the findings of this study.
Every company's medical staff has personnel to handle Data on File requests, which can be made by health care professionals & regulatory staff. How many requests actually come in is another issue altogether.
Salient, the Medical Information Departments at the companies I've worked at will only furnish published data when requested by an outside health care professional. "Data on File" is considered proprietary information, and as such the drug companies generally do not provide such on request.
For drug ads that do not meet the bar, internal compliance committees that include medical and regulatory folks are doing a poor job if that many bad ads are getting out. I would rather be Mr. Unpopularity at my company and keep the bad ads from going out than to play patsy to Marketing, which some of my colleagues do because they know that Marketing holds the key to their job security. Quite spineless IMO.
A couple of points... The percentage of ads that this study claims are out of regulation defies credulity, and suggests the authors are interpreting the regulations very differently than DDMAC or the professionals that review marketing materials at our clients. The authors admit the regulations are subjective, so they're clearly interpreting them differently from DDMAC and the medical, legal and regulatory teams at the advertiser companies. Relating this study to the "Bad Ad" program seems spurious. Do you think these folks would find today's ads any less non-compliant using their definition? I don't. and if so, on what basis? That DDMAC says it's having an effect? I've not seen any change in the behavior of medical/regulatory/legal boards for my clients. They've always been strict and thorough, and remain so as far as I can ascertain.
A fwq years afo it was all about what you could get away with to sell the drug. THat seems to be changing now hopefully. ONce the FDA brought it to the comapnies attention, the ad was pulled and nothing further ever happened so it was safe to play games like that to sell more drug.
ted nailed it. Read the two links below. The first one outlines the FDA "Bad Ad" program for health care providers, complete with an underwhelmingly comprehensive 2-minute video. The second link is the actual FDA Guidance from DDMAC on presenting risk information. The Bad Ad piece is overly general, non-specific, and as ted suggests lends itself to over interpretation and hence over reporting. On the other hand the guidance for industry is highly specific, and by its nature lends itself to a greater degree of compliance when followed to the letter.
Therefore, the Bad Ad program at its core is a highly misleading and essentially useless barometer of the actual and specific violations that would cause DDMAC to issue an NOV or Warning Letter to a company
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/DrugMarketingAdvertisingandCommunications/ucm209384.htm
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM155480.pdf
original-You mean, if I were an enterprising young bureaucrat at DDMAC (I know--indulge me for a minute) & I wrote a query letter to a drug company asking for data on file substantiation, they wouldn't provide anything but public domain material that doesn't support the claim?
I don't see that ending well.
Salient, maybe I misspoke. Anyone at FDA has a right to ask for data on file, and the sponsor knows that it will be treated confidentially. I was referring to a community physician who might call up the sponsor and ask for unpublished information. That type of request is usually denied.
Medical and drug information for each company usually provides the information from an unsolicited question. SOme companies like Pfizr were using Medical and Drug information to market the drug off-label. THe rep was suppose to just send the question to MDI that the rep made up and falsify that it was actually asked and the DM was hoping the physicain would read the info and start using the drug off-label. Some reps sent over 50 MDI requests in one week, impossible. Of course falsifying MDI requests and sending the information when not receiving an unsolicicted request is suppose to be class one felony. It is not prosecuted though. ANd companies do not enforce it either unless they want to get rid of one individual.
Original Insider:
I am compelled to correct you. I notice your "inside" information on pharmaceutical operations is usually skewed to present us in a negative light (for this article and others), so I wonder where your motivations actually lie. For those readers who actually work with medical information (who would reply to requests from "community physicians" or other outside requests) and promotional review committees, I can safely say that if someone contacted medical information seeking the "data on file" to support a promotional claim, they would receive it. In fact, such a reference would not be allowed in a promotional piece (at least at the 4 companies I can account for) unless it was known that the information would be provided upon request. Believe it or not, not all docs are dense and have their will controlled by 25 year old sales reps. In my experience (actual experience), when docs see clinical conclusions in promotional pieces supported by "data on file", they ask about it. Again, docs are not as ignorant as they are portrayed when it comes to their assumed intellectual weakness upon contact with a pharmaceutical company employee. Yes, there are instances where unpublished information will not be provided, such as on-going clinical trial information, but information used to support a promotional claim will be provided regularly.
to "company insider:
Falsifying an MDI request is not a "class one felony". Goodness, where do the commenter's here acquire their facts?
Felonies are typically divided by degrees (first degree, second degree), letters (class A, B, etc.) and more rarely, numbers (class one, two, three). The fed tends to use the letter system. States vary, but tend also to use degree and letters. Virginia however, does indeed use numbers.
another insider-It's possible that data on file procedures vary broadly from one company to the next, so you & original insider have different takes based on different experiences.
I would say, though, that if I'm a customer who is dissatisfied with how a data on file request is handled, I might become a former customer fairly quickly.
Salient, good point. It also depends on the rigidity of the company's legal department. In my companies it's gone both ways. I would prefer to keep all data on file under the broad category of "proprietary, technical and trade secret information", which is a legally recognized entity. If you consider the obverse then all data on file might be vulnerable to any nonregulatory request that would set a dangerous precedent IMO.
For example, let's say that the same physician above asked for unpublished data showing the efficacy of XYZ drug, and I then provide it to him/her. The next week that same physician calls me again and now asks for all of the negative data and results of failed studies showing lack of efficacy of the same XYZ drug. Since I've already set the precedent with the earlier request I might be obligated to provide the negative data. By shielding all unpublished data on file as legally protected proprietary, technical and trade secret information i don't have to deal with that contingency.
Another insider, I've done my share of sNDA's to support new promotional claims, some of which is unpublished, and all many hundreds of pages long. Where would you draw the line on what to send the doctor, ie the summary volume from the sNDA. That's long enough in itself. For me it's a lot easier to say no then to pick and choose the "appropriate" subset of unpublished data.
p.s you may be new to these boards but these blogs are done on a self contained basis. Cross posting on what you may think someone's editorial view might be based on other blogs is very uncool.
Dear Salient point, I recieved the informatin that falsfying requests for off-label information to the Medical and Drug unit was a Class 1 felony directly from a training tape promoted by the company with a legal officer of the company doing th presentation. He said specifically you could go to federal prison during his presentation and it was a Class 1 Felony. However, I do not know if the compliance officers knew what they were talking about but one would think they would. THe law also states that MDI is NOT to be used for promotional purposes though some companies do. ANd I totally agree with you that a physician would be able to get the information ON FILE from a marketing brochure by filing a request for the information. Like I said the law is not enforced except to fine the company.
Dear Salient point, I recieved the informatin that falsfying requests for off-label information to the Medical and Drug unit was a Class 1 felony directly from a training tape promoted by the company with a legal officer of the company doing th presentation. He said specifically you could go to federal prison
google unit was a Class 1 felony directly from a training tape promoted by the website with a legal officer of the website doing the presentation. He said specifically you could go to federal prison
google/Company insider:
Your legal officer was either trying to be "dramatic" to instill fear in the masses or needs to return to law school. I expect the former, as sales reps tend to be more attentive to intimidation tactics.