Let the patient beware

THE HEART problems linked to longtime use of the arthritis painkiller Vioxx have put a spotlight on the arm of government that is supposed to protect the public from harmful products, the Food and Drug Administration. Critics of the FDA in Congress have sensibly called for giving the agency more authority to require testing of drugs even after they have gained initial approval. The bill, which faces opposition from members of Congress responsive to drug-industry lobbying, should get a boost from a report yesterday from Congress's investigative arm.

According to the Government Accountability Office report, ''The FDA lacks clear and effective processes for making decisions about, and providing management oversight of, post-market safety issues."

Testing after a drug is approved for sale is often necessary because side effects show up only when the drug is used by millions and not by the few thousands included in pre-approval trials. In some cases, such as Vioxx, additional testing is needed because pre-approval trials are for relatively short periods of use even though the drug is being prescribed for chronic conditions. Vioxx's maker, Merck, pulled it from the market in 2004 when cardiovascular problems began occurring among users. The trial that finally spurred its withdrawal was being done not specifically for safety issues but to test the drug's potential in preventing colon cancer.

Currently, the FDA acknowledges, drug makers often promise prompt follow-up studies but fail to do them. The FDA says that as of last Sept. 30, there were 1,231 studies that companies had promised to do but nearly two-thirds of them had not been started. In many cases, the agency had moved the drugs through the approval process more quickly with the understanding that the studies would be done. The bill sponsored by Senators Charles Grassley of Iowa and Christopher Dodd of Connecticut would give the FDA the authority to require post-marketing tests.

The FDA insists it has already addressed many of the issues raised by the GAO, Grassley, and other critics. But one such critic, Dr. Alastair Wood, associate dean of the Vanderbilt Medical School, believes that even more thoroughgoing changes are needed. He favors creation of a drug-safety board that is independent of the FDA.

That step might be required at some point, but in the meantime Congress should pass the Grassley-Dodd bill. The measure is an overdue corrective for the pressure that drug makers in recent years have put on the FDA and Congress to let them bring drugs to the market more quickly. The public should not have to pay for greater regulatory efficiency with damaging and in some cases fatal side effects.