Congress Investigates FDA Order To Withhold Report on SSRIs

House and Senate Republican leaders have launched investigations into whether FDA managers prevented medical officer Andrew Mosholder from "presenting a safety review on antidepressants and suicidal behavior by children" to an agency advisory committee at a hearing last month, the San Francisco Chronicle reports (Waters, San Francisco Chronicle, 3/31). The Chronicle in February reported that FDA managers barred the testimony. According to unnamed FDA sources, Mosholder planned to present a preliminary report that found selective serotonin reuptake inhibitors may increase the risk of suicide in children. A senior FDA official said that Mosholder did not present the report because the results were not "finalized" (California Healthline, 2/2). After the hearing, the committee recommended that FDA issue stronger warnings to physicians about the potential link between SSRIs and suicidal behavior in children. FDA last week issued a public health advisory that calls for new warning labels on 10 different antidepressants -- which included both SSRIs and other antidepressants -- to include detailed warnings about the potential risk of suicidal behavior in patients who take the medications (California Healthline, 3/23).

The House Energy and Commerce Subcommittee on Oversight and Investigations plans to interview Mosholder and his managers to determine whether he "was in any way prevented from sharing all the information that he gathered with the advisory committee," subcommittee Chair Jim Greenwood (R-Pa.) said. In addition, Senate Finance Committee Chair Chuck Grassley (R-Iowa) last week sent a letter to HHS Secretary Tommy Thompson to request information on the "withholding of the report on the possible FDA internal investigation into the source of the information provided" to the Chronicle. The letter said that Grassley staff members have confirmed FDA managers barred the testimony that Mosholder planned to present and provided him with a "so-called script to read" to explain his decision not to present the report. Grassley said in an e-mail to the Chronicle that he has concerns about "the possibility that the FDA started an investigation to find out which staffer let the public know about this possible link. From what I know now, that person or persons might deserve a medal" (San Francisco Chronicle, 3/31). CBS' "Evening News" on Tuesday reported on the case. The segment includes comments from Vera Hassner Sharav, president of the Alliance for Human Research Protection (Attkisson, "Evening News," CBS, 3/30). The complete transcript of the segment is available online. The complete segment is available online in RealPlayer.