FDA Gets More Money to Monitor Drug AdsFeb 26, 2008 | Parker Waichman LLP
Drug advertising will be getting more scrutiny at the Food & Drug Administration (FDA) thanks to a new funding initiative. The FDA received $6.1 million in this year's budget to monitor consumer drug ads for fairness and accuracy. That's up from $2.2 million the previous year and $1 million the year before.
Recently, a string of drug safety scandals have highlighted what some have said are weaknesses in the way the FDA monitors the pharmaceutical industry. One area that has received a lot of criticism has been direct-to-consumer drug ads. In January, after the ENHANCE study was released that showed the anti-cholesterol drug Vytorin worked no better than cheaper statins, Congress began a probe of the way Vytorin was marketed by Merck and Schering-Plough. One issue that concerned lawmakers was why the drug makers - after having completed ENHANCE in April 2006 - kept running their catchy Vytorin ads on TV, touting it as being more effective than a statin alone.
Ads for Lipitor, another anti-cholesterol drug, also have attracted congressional scrutiny. One highly visible TV ad run by Lipitor-maker Pfizer features an endorsement by Dr. Robert Jarvik, the creator of the artificial heart. The ads use a body to show Dr. Jarvik engaging in hiking and rowing - activities that show him as more fit than he really is. Another major concern were statements Dr. Jarvik makes in the ads that some people could take to be medical advice. For instance, in the commercials, Jarvik says, “Lipitor is one of the most researched medicines. I’m glad I take Lipitor, as a doctor, and a dad.” But Dr. Jarvik is a medical scientist, not a licensed physician. In fact, Dr. Jarvik ended his training after medical school instead of completing a medical internship. Some congressional critics have charged that the Lipitor ads are misleading, and leave impression that Lipitor is the only available option for high cholesterol, when there are many cheaper medications available that achieve the same results. Since a congressional committee began investigating the Lipitor ads, Pfizer has decided to pull them.
In 2006, the Government Accountability Office (GAO) issued a report criticizing the FDA oversight of direct-to-consumer drug ads. The GAO said that the FDA was so overwhelmed by drug industry ad materials that only a "small portion" are ever reviewed by the agency. The FDA often didn't declare consumer ads false or misleading until after ad campaigns were over, the GAO said.
Right now, the FDA has only 13 workers devoted to policing direct-to-consumer ad materials. Only six are primary reviewers. Last year, the FDA received 12,616 drug ad materials directed to consumers. The FDA said that the budget increase will allow it to hire more people to review drug ads.
The boost in 2008 funds came after Congress approved user fees for drug ad reviews, but the program wasn't launched amid funding issues and opposition from some lawmakers. The proposed 2009 budget the Bush administration sent to Congress this month calls for $14 million from fees to fund 27 FDA positions devoted to the consumer-ad-review program. In exchange, the FDA would review TV drug ads within 45 days of getting them from drug makers — which is faster than many reviews occur now — and before the ads are seen by millions of viewers.
The drug makers' trade association, Pharmaceutical Research and Manufacturers of America, supports user fees. The association says timely FDA review would help drug makers meet marketing goals and lessen the risk of running ads later cited by the FDA for false or misleading content.
But some in Congress oppose this scheme, saying that it would give the drug industry too much influence over the FDA.