June 28, 2006

The FDA is facing increasing criticism from lawmakers about its enforcement policies, but it is unlikely to face true congressional pressure to strengthen those policies while Republicans maintain control of both the House and Senate, sources say.

Numerous lawmakers, led by Rep. Henry Waxman (D-Calif.) and Sen. Chuck Grassley (R-Iowa), and activists have been increasingly critical of the FDA's enforcement strategy, arguing that the agency is becoming lax in its oversight of drug manufacturers. But many observers note that none of their efforts are likely to result in substantive changes while the Republicans remain in power.

Republicans have not been inclined to hold the kind of congressional oversight hearings that can lead to changes in FDA policy, sources say. This leaves Democrats and activists continuing to issue reports, write letters and take other actions to warn of what they see as declining enforcement at the agency without any real changes taking place, numerous Hill staffers and activists say.

For instance, Waxman issued a report alleging that FDA enforcement has been in freefall since the beginning of the Bush administration. But even a staffer close to his office admitted that as a member of the minority party, Waxman has very little power to change agency practices.

While Waxman is the ranking member on the House Government Reform committee, he lacks the authority to call for oversight hearings that are necessary to place pressure on the FDA to change its enforcement practices, the House staffer told FDAnews. "Given that the Republicans are so tight with the pharmaceutical industry," nothing will change while they are in charge, the source said. Instead, Democrats have to hope to take control of one or both chambers in the midterm elections, the source added. (http://www.fdanews.com/did/5_126/)