FDA Woes May Lead to Credibility Problems

The sudden resignation of Food and Drug Administration Commissioner Lester Crawford in September again highlights problems at the agency. The FDA regulates products that account for one of every four dollars spent in the United States. But some say recent missteps could be costing FDA the credibility it needs to assure the safety of all Americans.

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Problems at the Food and Drug Administration were put in the spotlight last month when Commissioner Lester Crawford resigned unexpectedly. The FDA regulates products that account for one of every $4 spent in the US. As NPR's Julie Rovner reports, there are worries that recent missteps could hurt the FDA's credibility.

JULIE ROVNER reporting:

`This is hardly the first time the FDA has come under fire for its actions,' says former Commissioner David Kessler. He served under both the first President Bush and President Clinton. But Kessler, now dean of the Medical School at the University of California-San Francisco, says this is the lowest level of trust in the agency he's ever seen.

Dr. DAVID KESSLER (Dean, Medical School, University of California-San Francisco): For the first time, I've had physician colleagues come up to me and question the FDA. I've never seen that before. I've never heard that before.

ROVNER: Kessler says he's not even sure that the White House trusts the FDA. He points to the fact that the president tapped another political appointee to serve as acting commissioner, National Cancer Institute director Andrew von Eschenbach, rather than a career FDA official. The central question and the one that often bedevils Republican administrations, who say they want less government, is: How strong should FDA be? Kessler says the answer is `very strong.'

Dr. KESSLER: Well, it's one thing to deregulate certain industries. But the one thing we have learned is that when it comes to, literally, life-and-death decisions, the safety of the food we put on the table, the safety of the drugs our families take, that doesn't have anything to do with political ideology. It should not have anything to do with it.

ROVNER: But basing decisions on politics rather than science is exactly what the FDA has been accused of again and again. The loudest controversy this year has been the question of whether or not to allow the emergency contraceptive pill Plan B to be sold without a prescription. That's something religious conservatives strongly oppose. A decision was originally due last January, then promised by September. The FDA's announcement in late August that it would delay yet again prompted Susan Wood, then the agency's top women's health officer, to resign. And now Wood's resignation has been followed by that of Frank Davidoff, a Connecticut physician who was a member of one of the FDA advisory panels that overwhelmingly voted to make Plan B available over the counter.

Dr. FRANK DAVIDOFF (Physician): It seems like there was no justification for the delay in terms of the rules of the FDA and the evidence that was made available to the agency. And there could, really, only be one explanation, which was political influence.

ROVNER: The FDA's slow response on life-threatening side effects associated with popular antidepressant and painkilling drugs also brought accusations of inappropriate action from politicians from both parties. They said FDA was more worried about protecting the drug industry's profits than the American public's health. But not all FDA watchers share that opinion. Jim Greenwood is president and CEO of the Biotechnology Industry Organization and a former Republican member of Congress who's been critical of many of the FDA's past actions. Still, he says recent accusations that the FDA has become too politicized are overblown.

Former Representative JIM GREENWOOD (Republican, Pennsylvania; President, CEO, Biotechnology Industry Association): There is politics in everything, and I would argue that probably 99 percent of what the FDA does and is involved with is not involving highly politicized issues.

ROVNER: Greenwood says he thinks a bigger political problem is getting a commissioner, any commissioner, approved by the Senate.

Mr. GREENWOOD: I think we've seen recently that it's easier to confirm a chief justice to the Supreme Court than it is to get an FDA commissioner through the Senate.

ROVNER: Greenwood is right that Senate approval of the last two FDA commissioners were delayed by objections from a handful of senators. But the accusations of political decision-making have had another ill effect, says Frank Davidoff, the former advisory committee member. He says morale inside the agency is at a low point, which could lead to a dangerous brain drain.

Mr. DAVIDOFF: I think that there is the potential for beginning a sort of hemorrhage of talented people. And, you know, the people--they don't get paid a heck of a lot. They can make a lot more in--outside the agency, and a lot of them hang in there and do the work 'cause they think it's important.

ROVNER: Meanwhile, the administration is back in the search for a new FDA commissioner. During the nearly five years of the current administration, a Senate-confirmed agency chief has served only a total of 18 months. Julie Rovner, NPR News, Washington.

NORRIS: You're listening to ALL THINGS CONSIDERED from NPR News.

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