FDA Run as a Temp Agency

The Food and Drug Administration is one of the most effective and important operations of the American government. Thanks to its efforts, Americans buy food and take medicines almost without consideration to whether it is safe -- the record is so strong that safety is presumed. Yet, between the failure of the government to secure enough flu vaccine and the Vioxx disaster, that record is under scrutiny. One of the prime causes is the lack of leadership at the FDA. But that can only be expected when the FDA has had to make due with a temporary head for two-thirds of the time Mr. Bush has been in office.

First the facts. Mr. Bush will have served 48 months as president when he takes his oath of office for the second time next month. For 17 months, at the very beginning, the FDA had Commissioner Mark B. McClellan running things. Since he left, there has only been an "acting"commissioner. The White House says everything is just fine (which it also says about Iraq, the deficit and its prescription drug benefit). White House spokesman Trent Duffy claims that there is no legal requirement to hurry up and appoint someone -- acting commissioner Lester M. Crawford has done very well, and he's got all the power and responsibilities of a confirmed regulator.

A more likely explanation lies in politics. Senator Ted Kennedy is the leading Democrat on the Senate health committee, and he would likely give anyone Mr. Bush was likely to appoint real hell. That is almost certainly the case. Moreover, though, the policy of the Bush Republican Party is lassez faire. If the FDA has vacancies, the pharmaceutical industry is in better shape than if there is a gung-ho commissioner with the backing of the Senate thanks to his or her confirmation.

There is also a rule of life in a bureaucracy that says an organization is only as important as the person running it. If the person who ran the Peace Corp had a bigger budget than the air force and was given the title of Field Marshal, it would certainly count for more than it does now. Leaving the FDA without a Senate-confirmed commissioner signals to everyone, and most importantly to the 10,000 FDA employees, that the agency doesn't count for much at the White House.

Nor is it just acting commissioner Lester Crawford the only instance of this temp fever. Steven Galson is the acting director of the Center for Drug Evaluation and Research, and Paul Seligman is acting director of the Office of Drug Safety. They were both instrumental, according to some, in trying to get David Graham, whistleblower, to shut up about Vioxx. It is one thing to get the government off the back of the pharmaceutical industry. It is quite another to let the industry do as it will.

© Copyright 2004 by The Kensington Review, J. Myhre, Editor. No part of this publication may be reproduced without written consent.

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