Republican Congress "Must Fire Kessler"

If the Republicans in Congress want to fundamentally change the way Washington works, reining in the Food and Drug Administration must be a top priority, writes James Bovard in the Wall Street Journal. The use of arbitrary powers and intimidation has increased while David Kessler has headed the agency, he says.

The US medical device industry is downsizing at home and increasing overseas operations because of FDA delays, he says. The FDA has failed to reduce intolerable drug approval delays, seized products that could have benefited Americans and cracked down on freedom of speech. Its use of warning letters has grown dramatically, while it has refused to issue clear guidelines or rules for issuing letters. Moreover, he adds, patients are suffering from Dr Kessler's annulment of First Amendment rights. Proposed regulations have not been finalized, but since 1991 companies have been unable to tell doctors of new uses for approved drugs through promotions, and doctors do not learn of cutting-edge treatments. For example, drug companies cannot reprint and offer doctors, free, parts of medical textbooks if they mention off-label uses.

Mr Bovard does not go as far as supporting new House Speaker Newt Gingrich's plan to replace the FDA with an agency staffed by medical entrepreneurs with strict limits on their time in government, but does say Dr Kessler should be removed.