FDA Scientists Pressured to Change Findings

Nearly one in five scientists at the Food and Drug Administration have been pressured to exclude important data from agency documents, a new survey of nearly a thousand FDA scientists shows.

The Union of Concerned Scientists (UCS) today released survey results that demonstrate, in their words, "pervasive and dangerous political influence of science at the Food and Drug Administration (FDA)."

Among the most revealing findings:

* 18.4 percent said that they "have been asked, for non-scientific reasons, to inappropriately exclude or alter technical information or their conclusions in a FDA scientific document."

* More than a third of the respondents did not feel they could express safety concerns even inside the agency.

* 61 percent of the respondents knew of cases where "Department of Health and Human Services or FDA political appointees have inappropriately injected themselves into FDA determinations or actions."

* Only 47 percent think the "FDA routinely provides complete and accurate information to the public."

* 81 percent agreed that the "public would be better served if the independence and authority of FDA post-market safety systems were strengthened."

* 70 percent disagree with the statement that FDA has sufficient resources to perform effectively its mission of "protecting public health."

The FDA has been underfunded, understaffed and, as this new survey shows, subjected to outside pressures from the industries it regulates and political operatives whose sole motivation is satisfying electoral constituencies like the right-to-life crowd. Yet this agency has the job of regulating a quarter of the U.S. economy -- the nation's food, drugs, medical devices and veterinary medicine industries -- to ensure their products are safe and effective.

How can the public think it is doing its job well if four of five scientists inside the agency think its safety system sucks; two-thirds think the agency lacks adequate resources to do the job; and half believe the public isn't getting adequate information?

Senators Ted Kennedy and Mike Enzi will be introducing legislation next week to reform the FDA. At first glance (and it is only the briefest glance), it seems to be aimed at making the FDA even more industry-friendly while taking a few halting half steps to improve its drug safety system, which is the only impetus for reform. I'll write more on that legislation after I've had a chance to give it a closer read.

Posted by gooznews at July 20, 2006 03:02 PM