Emails Suggest FDA In Bed With Drug Industry
Democrats, Republicans and even the Food and Drug Administration’s White House-appointed commissioner have said that the cash-strapped FDA is dire straits.
But internal agency emails show that what resources FDA does have may go to regulatory changes favored by the pharmaceutical and drug-device industry, as opposed to the wishes of the FDA’s own science board.
Rep. Henry A. Waxman, (D-Calif.) chairman of the House Committee on Oversight and Government Reform, wrote a letter to FDA Commissioner Andrew von Eschenbach sharply critical of agency priorities. Waxman drew upon agency emails obtained by the committee.
In one June 2007 email Sheldon Bradshaw, FDA’s former chief counsel, writes to his assistant, Scott Danzis, asking Danzis to lay out the agency priorities. Danzis responded with a list that Waxman, in his letter, assails as “long-sought goals of the drug and device industries.”
The recommendations from Danzis include lifting restrictions on companies that wish to write journal articles that promote uses of off-label drugs not approved by the FDA. The emails also seek to expand a Bush administration favorite—the “preemption principle”—which argues that an FDA regulation of a product preempts consumers from suing the product manufacturer.
The emails recommendations were passed on to Tevi Troy, deputy secretary of the Dept. of Health Human Services, which the FDA is under. And in the past year HHS and FDA have acted on the email: rules have been finalized to permit journal articles on alternative drug uses and expand the preemption principle.
In the meantime, Danzis and Bradshaw have left FDA for jobs at law firms where they each represent the pharmaceutical industry.
When the FDA’s own Science Advisory Board blasted the agency last November, they said nothing about journal articles or the preemption principle. Their focus was on a “broken” system of safely importing food and drugs, leading to an increasingly dangerous food supply. Those will soon be the problems of the next administration’s FDA.