Side effects in the Senate
THE FOOD and Drug Administration reform bill passed by the Senate last week goes some distance toward protecting the public from another dangerous drug like the arthritis painkiller Vioxx, which caused serious cardiovascular problems. But the Senate could have done more to make drugs even safer. When the House of Representatives draws up its bill, it should go the Senate one better.
The signal achievement of the Senate bill, whose chief sponsors are Democratic Senator Edward Kennedy and Republican Senator Mike Renzi of Wyoming, is the power it gives to the FDA to require, not just request, that pharmaceutical companies study drugs' safety after they go on the market. Violators would face fines of up to $2 million.
Pre-approval testing is often not sufficient to detect side effects, because the number of people tested is not great enough to reveal uncommon but harmful reactions. Also, some adverse conditions show up only after the drugs have been taken for extended periods of time, and not during the limited periods of clinical trials.
As another post-approval safeguard, the bill calls for a surveillance system to track the side effects of new drugs, drawing on data from tens of millions of patients. In addition, the drug companies would be required to post results of some but not all clinical trials of new drugs on a public database, a measure designed to make it more difficult for the firms to hide potential safety concerns.
The bill falls short, however, in not adopting one of the chief recommendations in a report on FDA reform last year by the Institute of Medicine, a branch of the National Academy of Sciences. The institute called for a two-year moratorium on direct-to-consumer advertising for new drugs.
Vioxx would not have become such a threat to the public -- or earned
Another sensible suggestion from the Institute of Medicine was that the FDA director be appointed to a six-year term, which would provide a degree of protection from political influence.
As the role of prescription drugs in healthcare has grown, so has the importance of the FDA. Congress will almost certainly pass a reform bill in the next few months, because by Sept. 30 it must reauthorize the agency to collect the fees from industry that fund much of its work. The Kennedy-Renzi bill strengthens the agency, but there is still room for the House to build stronger firewalls between the public and potentially dangerous drugs.
(Correction: The name of Wyoming Senator Mike Enzi was misspelled in an editorial Monday.) 