In the past four years, the Food and Drug Administration has taken a noticeably less aggressive approach toward policing drugs that cause harmful side effects, records show, leading some lawmakers, academics and consumer advocates to complain that the agency is focusing more on bolstering the pharmaceutical industry than protecting public health.
From 2001 to 2004, three important drugs were taken off the market, compared with 10 that were recalled from 1996 to 2001.
Two of the three were withdrawn in the very early months of the Bush administration. The third, the blockbuster arthritis drug Vioxx, was pulled in September at the initiative of its maker, Merck & Co., without FDA involvement.
In the same period, the number of warning letters sent by the FDA's drug marketing office challenging misleading or dishonest drug advertising also plummeted. From 1996 to 2001, the agency issued about 480 cease-and-desist letters. Over the past four years, the total has been about 130.
The decrease in FDA enforcement has come despite a steadily rising number of reports of potentially harmful side effects from approved drugs. From 1996 to 2004, the annual number of these "adverse events" almost doubled.
Few doubt the FDA remains the world's gold standard for drug regulation, and the agency fiercely defends its record. Nonetheless, Steven Galson, acting director of the FDA Center for Drug Evaluation and Research (CDER), said his agency "has learned some important lessons in the past year and will make some changes" based on an upcoming Institute of Medicine study and its own reviews. The agency has "taken the criticism to heart," he said. He added, however, that some of the falloff in recalls may be the result of a decline in new drug approvals.
Concerns about the FDA's safety monitoring have been growing ever since Congress required in 1992 that the industry assume a significant share of the costs of evaluating new drugs. These "user fees" now pay for more than half of CDER's annual budget of almost $500 million, and the percentage is growing steadily.
Those concerns have taken on new urgency since the calamitous withdrawal of Vioxx, a move that focused sharp attention on whether the agency has become lax in overseeing the drug supply and too cozy with the industry.
Recent events "pretty clearly indicate the safety surveillance system isn't working," said Jerry Avorn, a Harvard University drug safety specialist and author of "Powerful Medicines: The Benefits, Risks, and Costs of Prescription Drugs."
"It's a little like driving drunk," he said. "You can go for a number of trips inebriated and not get in an accident, but the risk is there and eventually you'll have a crash."
