FDA Cites Fewer Misleading Prescription Drug Advertisements, Rep. Henry Waxman Says

The FDA in recent years has allowed more misleading prescription drug advertisements to air "unchallenged" and has taken fewer enforcement actions against pharmaceutical companies that "repeatedly overpromise" the benefits of their medications, Rep. Henry Waxman (D-Calif.) said on Thursday, the AP/Richmond Times-Dispatch reports. According to a report compiled by the Democratic staff for the House Committee on Government Reform at the request of Waxman, the FDA in 2003 issued 24 citations to pharmaceutical companies for false or misleading ads, a 75% decrease from 1999 and 2000 (AP/Richmond Times-Dispatch, 1/30). The report also found that the delay between the launch of misleading ads and FDA citations has increased to an average of six months. The report said that the decrease in FDA enforcement has occurred despite a promise last year by FDA Commissioner Mark McClellan to "get tougher on drug firms whose advertising stretched the truth," the Boston Globe reports (Rowland, Boston Globe, 1/30). Waxman added that the decrease in FDA enforcement "does not mean drug advertising became more believable," the AP/Times-Dispatch reports. The FDA in 2003 reviewed an average of 3,200 prescription drug ads per month, a 6% increase from 2002, and complaints to the agency about alleged misleading ads remained the same, the report found. Waxman said that the FDA in 2003 cited one prescription drug ad for every eight complaints, compared with one citation for every seven complaints in 2002 (AP/Richmond Times-Dispatch, 1/30). In a telephone interview on Thursday, Waxman said, "We found that enforcement action dropped significantly in the first two years of the Bush administration. While Mark McClellan pledged to do more ... FDA has gotten worse in their enforcement actions."

FDA officials said that an increased number of citations issued for prescription drug ads "does not necessarily ensure quality" and that the agency next week plans to release new recommendations to "make it clearer what drug companies can say" in their ads, the Globe reports. Peter Pitts, association commissioner for external affairs for the FDA, said, "It's not a numbers game. It's not the letters count. It's about protecting the public health." According to Pitts, although the FDA has cited fewer prescription drug ads in recent years, the citations issued today "have teeth, so the recipient knows we mean business." He added, "The commissioner has significantly increased enforcement out of FDA" (Boston Globe, 1/30).