Lawmakers seek probe of disagreements at FDA

Two Republican lawmakers on Tuesday asked for an investigation into how health regulators handled internal disagreements such as the conflicting views over the risks of antidepressants.

Reps. Joe Barton and Jim Greenwood said their request was prompted by the Food and Drug Administration’s review of whether certain antidepressants might raise the risk of suicide in children and teenagers.

An FDA reviewer, Dr. Andrew Mosholder, concluded there was a link, but other agency officials disagreed. The FDA has not yet reached a determination.

Mosholder is a scientist in the FDA’s Office of Drug Safety. Staff from another division, the Center for Drug Evaluation and Research, decided Mosholder should not present his views at a February advisory committee meeting, according to a letter from the agency made public in April.

The lawmakers, in a letter, asked the Government Accountability Office (GAO) to explore past disagreements between the two divisions and whether “each of these cases resulted in appropriate regulatory action.”

Barton, from Texas, chairs the House Energy and Commerce Committee. Greenwood, from Pennsylvania, heads the panel’s investigations subcommittee.

In addition to the antidepressants review, the committee “has information raising questions about the handling of other disagreements” related to Roche acne drug Accutane, Aventis SA’s rheumatoid arthritis drug Arava, Johnson & Johnson’s withdrawn heartburn drug Propulsid and Pfizer’s withdrawn diabetes drug Rezulin.

An FDA spokeswoman did not immediately respond to a request for comment. Agency officials have defended their dealings with Mosholder, saying they acknowledged disagreement about the antidepressant data at the public advisory panel meeting.

Provided by ArmMed Media
Revision date: July 7, 2011
Last revised: by Dave R. Roger, M.D.