FDA and the Life-Sciences Industry: Business As Usual?(Essay‪)‬

On April 15, while most Americans were signing and mailing their 1040s, Rep. Joe Barton (R-TX.), chair of the House Energy and Commerce Committee, issued a press release in which the Food and Drug Administration admitted, for the first time, that an important report regarding concerns for the safety of children taking prescription antidepressants had not been released to the public. As the complex story of the FDA's oversight on antidepressants unfolded, it fueled mounting concerns about the extent to which the pharmaceutical industry has permeated the agency and how it may be influencing the agency's policies, practices and regulatory actions. The FDA'S admission was contained in a response to an inquiry from Barton and Rep, James Greenwood (R-PA), both of whom served on the Energy and Commerce Committee's Oversight and Investigations Subcommittee. The FDA acknowledged that an internal consultant had concluded that data supported an association between the use of antidepressants and suicidality in children. The internal consultant was Andrew Mosholder, a member of the agency's Office of Drag Safety and a former reviewer for the Division of Neuropharmacological Products of the FDA's Center for Drug Evaluation and Review (CDER). After conducting a seven-month review, Mosholder recommended that the FDA take additional regulatory action. (1)