Letting the Dogs Out

The U.S. drug industry spent $4.1 billion hawking pharmaceuticals to consumers last year, a 28% jump from 2003. In the next decade, U.S. taxpayers will shell out at least $800 billion to buy them under the new Medicare drug benefit. With so much at stake, who are the federal watchdogs standing guard for consumers? Unfortunately, they are more Chihuahua than Rottweiler.

President Bush’s budget for fiscal year 2006 gives the Food and Drug Administration only $33.4 million to monitor the safety of drugs already on the market, a pittance next to $12.4 billion for the administration’s war against illegal drugs.

The FDA is not only ridiculously underfunded for its challenges, it lacks the basic authority to require doctors and hospitals to report “adverse events,” meaning deaths or injuries thought to be caused by drugs or other medical products the agency regulates. In 1993, the FDA set up its MedWatch system to spot such medical errors, but by the agency’s own admission, only about 10% of adverse events are reported.

Earlier this month, the Senate seemed ready to discuss such deficiencies during confirmation hearings for Lester M. Crawford, Bush’s nominee for FDA chief. The hearing was hastily canceled and Crawford’s nomination may be withdrawn over allegations of personal impropriety at work. That’s bad news for the FDA, which has been without a permanent leader for more than a year. All the more reason for Congress to step in.

Sens. Charles E. Grassley (R-Iowa) and Christopher J. Dodd (D-Conn.) have been working overtime on a bill that would address some of these problems. It would chiefly make the Office of Drug Safety, the FDA office that evaluates drugs after they go to market, independent from the Office of New Drugs, which initially approves the safety and efficacy of drugs. As Grassley explained last month, under the current setup “the office that reviews the safety of drugs [is] ... under the thumb of the office that puts the drugs on the market in the first place.”

Grassley and Dodd plan to introduce the bill this week in the Senate Health Committee, but the legislation will go nowhere unless the committee’s chairman, Mike Enzi (R-Wyo.), schedules it for a vote.

Some critics have called measures like the Grassley/Dodd bill overcautious, a reaction to recent problems with popular drugs such as Vioxx. It’s hard to buy that charge regarding a bill that would only give some needed freedom to the watchdogs.