FDA Urges Docs To Report Misleading Drug Ads

WASHINGTON — The Food and Drug Administration said Tuesday it will begin asking doctors to keep an eye out for misleading drug advertisements as part of the agency's latest effort to police the pharmaceutical industry's multibillion-dollar marketing machine.

The agency's "bad ad program" urges doctors to report ads and sales pitches that violate FDA rules. Drug companies are legally required to present a balanced picture of a drug's benefits and risks in promotions, though critics charge that many TV and magazine ads fail to do so.

Currently the FDA relies on a few dozen staffers to review hundreds of pharmaceutical ads, brochures and presentations voluntarily submitted by companies or reported to the agency by drug industry personnel.

The agency issues warning letters to companies using misleading materials, but because of the volume of submissions those letters often aren't sent until months after the ad is released – and in some cases after the ad is no longer in circulation.

As part of its new program FDA will offer doctors training at medical conferences to help spot misleading ads. They can report advertising violations anonymously by e-mailing badad(at)fda.gov or calling 877-RX-DDMAC.

"The Bad Ad Program will help health care providers recognize misleading prescription drug promotion and provide them with an easy way to report this activity to the agency," said Thomas Abrams, director of FDA's drug advertising division.

The drug industry's lobbying group said in a statement it supported the effort as "another step to help educate – and receive feedback from – health care providers about prescription drug advertising and promotion."

The lobbying group, Pharmaceutical Research and Manufacturers of America, represents most of the world's largest drugmakers, including Pfizer, Merck & Co. and GlaxoSmithKline.

Drugmakers spend about $20 billion per year to promote their products in various mediums, ranging from medical journal ads and information booths at conferences to multimillion dollar TV campaigns.

About $4 billion of industry spending goes toward patient-targeted advertisements. Some drug industry critics charge TV drug advertisements encourage over-prescribing of medications by emphasizing the benefits and minimizing the risks.

The FDA is also conducting a 2,000-person study to determine if the relaxing, upbeat images featured in TV drug ads distract consumers from warnings about the drugs' risks.

Comments

[Mama Rachel]

11:48 PM on 05/17/2010

Isn't this redundant? They're ALL misleading. Anytime a pharmaceutical manufacturer is advertising directly to potential patients, the goal is to create demand where it would not otherwise exist.

My favorite example is 'restless leg syndrome'. I never learned about THAT in med school. It's hugely time consuming for Drs. to explain to patients why a given medication is NOT indicated for them, and most don't bother. It's much easier to write the scrip.

Bad, bad medicine for everyone involved.

http://mamasoncall.com

[Crushy]

12:11 PM on 05/16/2010

This seems weird. Its the FDA's job to watch out for misleading ads, no? Why are they asking doctors to do it?

Im probably being paranoid, but considering the intermingling of the FDA and pharmaceutical companies to the point where they both seem to have the same agenda (drug everybody) I hope this is not a way to identify doctors that do not agree. nah, probably not.

[Whitley2009]

07:00 PM on 05/14/2010

I thought the FDA was supposed to be looking for such misleading ads. Why are they throwing the responsibility on the MDs. Did they ask the pharmacists?

They are so phuquing correct. Their top executives will privately admit they work for BigPharma, not as policemen for the public.

Are they too damn busy to read the advertisements?

[hxwhite]

08:02 PM on 05/14/2010

The FDA has their hands full trying to smooth over concerns about injecting contaminated rotavirus vaccines in infants and toddlers.

"Both products had been shown to contain fragments of DNA from porcine circovirus 1 (PCV1) or 2 (PCV2), neither of which are known to cause disease in humans. PCV2, which was found in RotaTeq only, has been known to cause illness in pigs."

http://www.medpagetoday.com/InfectiousDisease/Vaccines/20106

They're studying the potential for adverse reactions while continuing to vaccinate. CLOWNS!

[Whitley2009]

08:25 PM on 05/14/2010

Thanks for comfirming what I have been saying on HuffPost, and catching hell about it. It is true that the FDA represents the BigPharma and vaccine companies. They are supposed to be policement for the public, but the reverse is true.

And, what you say about the vaccines is absolutely true.

[RaisingAwareness]

05:09 PM on 05/14/2010

I have more confidence in the word of the consumer than I do of doctors who make a 'killing' distributing the product. So why aren't the consumers listened to by the FDA? That would change things.

[whatshappeningtoUSA]

01:56 PM on 05/14/2010

It's a start to help restrain pharmaceutical companies from making lame claims that may actually cause damage to your person. It's only taken the FDA how many years to ask for feedback?
Allowing Big Pharma to advertise on TV was a bad move!

[NorthSide]

02:16 PM on 05/14/2010

Can you cite an ad fro a prescription drug (not a vitamin nostrum) that is misleading, that does not indicate exactly what is on the FDA-mandated package insert?

[whatshappeningtoUSA]

02:37 PM on 05/14/2010

Yes. But i don't want to be sued for libel or slander. Look at drugs as effectiveness rather than cures. Some drugs are 70% effective but then their generic counterparts are 45% effective. I'm a bit concerned about off-label uses for drugs. If/When you take a drug err medication, please note you are in the study for it. The study never ends, believe it or not. Sure the Clinical Pre-Market Studies end, but they are positively geared....it's only when you put that drug in the market place do you know what the real issues are going to be.

[RaisingAwareness]

05:05 PM on 05/14/2010

Big Pharma Blogger Alert!

[organicconnect]

01:55 PM on 05/14/2010

Why is the FDA trying to offload its job on to doctors? The FDA seems to be asleep at the wheel and has been for a long time. This idea of having doctors "keep an eye out" is a joke. Do your job, FDA. Stop being a rubber stamp for companies that make the drug cartels look like boy scouts. Ads that have 5 seconds of copy about 55 seconds of disclaimer should be a clue that something is wrong. Obviously the hundreds of millions of dollars in fines already paid by BigPharma has not deterred their bad behavior. Note to the leviers of fines, increase them 10x. That might take them out of the "just the cost of doing business" category.

[NorthSide]

12:28 PM on 05/14/2010

This is all very well, but where do I report fraudulent supplement ads? I have seen ads on TV and other venues that promise completely impossible results for these vitamin nostrums, but apparently FDA cannot prosecute them. I have seen preparations that purport to make me taller (flatly impossible after your long-bone growth plates fuse in your late teens), make my penis longer, grow hair back on my scalp etc, etc. With ads for prescription medications, the information on offer is vetted by the FDA on the package inserts. For vitamin stuff, its the wild west.

[RaisingAwareness]

05:05 PM on 05/14/2010

Big Pharma Blogger Alert!

[saskatoonie]

02:48 AM on 05/19/2010

I think we should have a Scientologists alert here for you, many of your posts seem to be very strident and anti-medication!

[MichelleRodulfo]

10:49 AM on 05/14/2010

I may be wrong, but don't doctors already have a lot on their plates? At least the doctors I know do. Asking them to become FDA watchdogs just doesn't sound realistic. And as for that 2,000 person study to determine if the relaxing, upbeat images featured in TV drug ads distract consumers from warnings about the drugs' risks - why bother? We know already know that these factors play a huge role in distracting consumers - that's why they are there.

http://michellerodulfo.com

[whatshappeningtoUSA]

02:00 PM on 05/14/2010

part of their job, believe it or not, is to look after their patients health and safety. most doctors don't even know what they're prescribing. they listen to the pharmaceutical rep who only talks positive talking points in making the sale. and yes, believe it or not some doctors will prescribe a medication soley based on the "cuteness" of the pharmaceutical rep. your beef really is with the insurance companies for making doctors jump through hoops. doctors anyways are basically just midwives of pharmaceutical companies. besides writing prescriptions, and surgeons cutting, what do they really do? i respect doctors but their role is limited now. thank insurance companies for that!