FDA more cautious in approving new drugs after Vioxx

Many pharmaceutical companies and industry observers say that FDA is “quietly becoming more assertive about keeping new drugs off the market or refusing to approve new uses for existing medications” in response to criticism since the 2004 Vioxx recall, the New York Times reports.

Executives and analysts “point to numerous unexpected delays and rejections” of products, such as the agency’s decision earlier this month to delay approval of Genentech’s colon cancer drug Avastin as a treatment for breast cancer. Genentech said FDA apparently has tightened requirements for certain types of clinical trials. FDA did not make anyone available to be interviewed and denies that it has become more cautious, according to the Times. Statistics “show signs of a more cautious stance—at least for new drugs that the agency does not consider major advances over ones already available,” the Times reports. Of 14 drugs submitted to FDA in fiscal year 2005, the agency approved only one on the first try—the lowest rate in at least 10 years, according to the Times.

FDA “does not show signs of a slowdown” in approval rates for new drugs that “merit a priority review,” the Times reports. Ira Loss—who follows FDA for Washington Analysis, a firm that monitors federal agencies for investors—said, “The uproar that’s occurred in the wake of Vioxx has clearly had an effect on the way the FDA approaches its work. The agency doesn’t hesitate to say ‘No’ or ‘Send me more data.’” Lee Simon, a former FDA division head, said, “I speak to reviewers, and they all feel very worried that the decisions they make may come back to haunt them” if drugs are later found to be dangerous. However, Sidney Wolfe, director of the Health Research Group at Public Citizen, said that complaints from the drug industry about delays are “just major kvetching” and that companies lacking quality drugs in their pipelines are using FDA as a scapegoat (Pollack, New York Times).

Related Broadcast Coverage

NPR’s “Talk of the Nation/Science Friday” on Friday in the first hour of the program is scheduled to include a discussion of FDA and prescription drug safety. Guests on the program are scheduled to include Sheila Burke, deputy secretary and chief operating officer of the Smithsonian Institution; Todd Golub, director of the cancer program at the Broad Institute of MIT and Harvard and investigator at the Dana Farber Cancer Institute; and Scott Lassman, general counsel for the Pharmaceutical Research and Manufacturers of America (Flatow, “Talk of the Nation/Science Friday,” NPR). The complete segment will be available online in RealPlayer after the broadcast.