FDA cracks down on misleading ads or promotions through new ‘Bad Ad’ program
Recently, FDA rolled out their ‘Bad Ad’ Program asking doctors and other health care providers to help ensure that ads and other promotions by the drug industry are “truthful and not misleading.”
FDA rolled out the ‘Bad Ad’ Program a month ago to enlist health care providers in recognizing and reporting untruthful or misleading promotional activities. This will help FDA’s efforts to protect consumers by identifying suspect or problematic advertising more quickly. Additionally, the program also encourages health professionals to help monitor and report some of the deceptive or illegal promotional activities taking place behind-closed doors.
To report an ad or a promotion that may be misleading or that may be suspect, contact FDA by email (BadAd@fda.gov) or phone (877-RX-DDMAC, which is 877-793-3622). Reporting can be anonymous, but FDA would like contact information for follow-up.
In 2007, the drug industry spent just over $5 billion on direct-to-consumer (“DTC”) advertising, a quarter of their the total $20 billion spent on promoting drugs. According to the Government Accounting Office, the drug industry spends nearly three times as much on their sales efforts targeting physicians, nurses, and other prescribers then they spend in direct-to-consumer marketing. The ‘Bad Ad’ Program recognized this, and seeks to increase the FDA’s ability to detect violations in the area of heaviest pharmaceutical promotion – communications between pharma reps and physicians taking place behind closed doors. Whether these are meetings in medical offices, or at other events, such as dinners, speaker training sessions, and continuing medical education events, FDA’s website sums it up like this:
Companies send us their sales aids—the booklets and campaign materials for their drug that the reps are supposed to use in the field when they talk with doctors—and we review those materials. But we have limited access to the promotional activities in these settings. That’s why we’re asking health care professionals to partner with us in our efforts to stop misleading prescription drug promotion.According to the FDA website, enlisting the help of health care providers will help to address FDA’s own “limited ability to monitor promotional activities that occur in private.”
Consumers encouraged to report ads that are misleading: The “Bad Ad” campaign to educate and empower health care providers complements FDA’s EthicAd campaign, which was launched earlier this year to educate consumers about misleading Direct-to-Consumer (DTC) drug promotion. The FDA has also asked for consumers to help monitor deceptive or misleading ads.
Consumers are encouraged to report an ad they think is misleading, or that does not prevent the benefit and risk information in ‘fair balance’ by calling FDA at 301-796-1200 or writing to the FDA Division of Drug Marketing, Advertising, and Communications (DDMAC).
Consumers can also report adverse effects or reactions to drugs by calling 1-800- FDA-1088, or at http://www.fda.gov/Safety/MedWatch/default.htm
The ‘Bad Ad’ Program seems to be FDA’s latest change to revive their important role in protecting consumers from deceptive advertising of prescription drugs. Consider this: in the first 16 months under the new Obama administration, FDA has issued as many warning or enforcement letters on direct-to-consumer advertising (31) as did the Bush administration in its last 5 years at FDA’s helm.
Number of FDA enforcement letters on DTC Ads, 1997 – May 2010:
(Sources: GAO study, 2006; FDA, Jan. 1, 2006-May 31, 2010)
After years of the Bush administration’s interference with FDA efforts to monitor and protect consumers from being mislead, the FDA’s return to this vital role protecting consumers is welcome.
Bad Ad spawned by ex-execs from the industry Interestingly, the idea for ‘Bad Ad’ came from two former drug company execs that ‘switched teams’ and now work for the FDA as advertising watchdogs. Mike Sauers, one of the bright minds behind this program, states that the goal of ‘Bad Ad’ is to teach doctors “how to be better consumers of information they receive from the drug reps.”
The FDA plans a three phase roll-out for ‘Bad Ad.’ During phase one, which began last month, the FDA will mail 33,000 informational letters to healthcare providers describing this effort. The FDA will also engage and train health care providers at select medical conventions about how to recognize misleading prescription drug promotions and how to report violations to the FDA. The FDA is also partnering with certain medical societies to distribute educational materials. For Phases 2 and 3, the FDA has said little more than that they plan to expand these efforts and update their materials, but we can envision FDA enforcing the law using their new authority to assess civil penalties and fines of up to $250,000 for each violation.
Doctors and other health care providers should be concerned about how the drug industry has consistently deceived their drug choices through the illegal promotion of ‘off-label’ uses of prescription drugs such Zyprexa, Geodon, Lyrica, Zyvox, and Bextra. In fact, in the last six years, 5 of the 8 largest drug makers have been caught and plead guilty to such illegal off-label promotion of unapproved uses of prescription drugs. (Bristol-Myers Squibb also paid $515 million to settle claims about off-label promotion in 2007, without admitting or denying any wrongdoing.)
These activities have the potential to put a doctor’s patients at risk. But the best way for health care providers to help is by watching for misleading industry practices, and alterting FDA. ‘Bad Ad’ is one of several innovative steps FDA is currently taking to crack down on the widespread, potentially harmful promotions of prescription drugs that are misleading or untruthful.
The FDA deserves to be commended on this important effort. Reaching out to health providers and consumers is an important start to increasing FDA’s capacity to protect consumers from misleading drug promotions. But to effectively monitor a $20-billion-dollar-a-year promotional industry, FDA needs consumer support for a significant expansion of their staffing and resources.