In May we reported that the U.S. Food and Drug Administration (FDA) released proposed guidelines for <"http://www.yourlawyer.com/practice_areas/defective_drugs">drug and medical device television ads meant to reduce diversion tactics. USA Today is now reporting that the $4.3 billion advertising sector is facing strong opposition from lawmakers hoping to put a stop to the advertising trend.
Lawmakers argue that direct-to-consumer (DTC) advertising, is responsible, in part, for the rising cost of health care and that the ads, described as â€œcomplicated,â€ discuss illnesses about which consumers might not even be aware. “There are legitimate reasons to criticize DTC, but it doesn’t cause problems for pricing, it raises demand,” said Bob Ehrlich, CEO of DTC Perspectives, a publishing and consulting company that specializes in DTC marketing, quoted USA Today.
Representative James Moran (Democrat-Virginia) is hoping to eliminate DTC ads, citing decency standards; Representative Henry Waxman (Democrat-California) wants drug manufacturers to hold off marketing for a period following FDA approval, reported USA Today. Representative Jerrold Nadler (Democrat, New York) is hoping to have the federal tax code updated to ban drug companies from deducting ad costs as a business expense, USA Today added.
DTC ads have long been criticized. Earlier this year GlaxoSmithKline was cited by the FDA when it ran an ad for the prostate drug Avodart that featured a man working on a model of the solar system and who must stop painting to â€œmake frequent trips to the bathroom,â€ said the Star Tribune in a prior report. A colleague then suggests Avodart, saying, â€œother medicines, they donâ€™t treat the cause, because they donâ€™t shrink the prostate.â€ FDA regulators, reported the Star Tribune, said the claim is bogus and in a letter to Glaxoâ€™s U.S. officials, wrote that Merckâ€™s Proscar reduces prostate size, and â€œhas a similar indicationâ€¦. Nothing in the labeling for Avodart suggests any specific advantage.â€
Recent FDA guidelines suggest that both benefits and risks be explained in similar type styles and voice-overs in DTC ads, said Reuters previously. The guidelines were prompted by complaints pointing to drug maker tactics to minimize risks and play up benefits via distracting music and type styles, explained Reuters.
For instance, earlier this year, Consumer Reports questioned the ethics of a Chantix (varenicline) ad that, while never mentioning Chantix, appeared to market the drug while seeming to be a public service announcement. The commercial focused on a smoking cessation Website entitled MyTimeToQuit.com that presented information in a public service format, said Consumer Reports, pointing out that it is only at the adâ€™s end that hints about the adâ€™s originâ€”Pfizerâ€”are discreetly revealed. The FDA approved Chantix in 2006; side effects may include suicidal ideation, depression, and violent behavior.
As part of a settlement with 27 states, Bayer had to change how it advertises birth control medication Yaz, reported BizJournal previously. Late last year, the FDA sent Bayer a warning letter over two Yaz televisions ads that misled consumers into believing Yaz could help relieve symptoms associated with Pre-Menstrual Syndrome (PMS) and could help in the treatment of specific types of acne. The FDA has never approved Yaz for either of these medical issues, said BizJournal. Bayer was mandated to implement a $20 million dollar campaign to â€œremedyâ€ the misinformation it promoted and must submit all subsequent television advertisements to the FDA for pre-approval; comply with the FDA on TV and print advertisement suggestions; and â€œclearly and conspicuouslyâ€ disclose for what the FDA has approved when discussingâ€”in its print adsâ€”those symptoms Yaz can treat, said BizJournal.