FDA Under Fire for Withholding Documents on Antidepressants in Children

Strategic Insights -

A House committee hearing into the effects of antidepressants on children took a contentious turn on Thursday, as the chairman accused the Food and Drug Administration of withholding documents. Representative Joe L. Barton, Republican of Texas, cited a leaked email instructing officials not to release the documents, which he claimed showed the agency's deliberate defiance of the committee. The hearing highlighted concerns over the safety of antidepressants in children and the drug industry's tendency to suppress unfavorable trial results.

Key Takeaways:

  • The FDA is accused of withholding documents on the effects of antidepressants on children, despite a House committee's request for information.
  • Representative Joe L. Barton cited a leaked email from Patrick McGarey, an FDA official, instructing others not to release the documents.
  • The FDA has provided thousands of pages of information to the committee, but the chairman claims it is not sufficient.
  • Seven top executives from major pharmaceutical companies, including Pfizer, Wyeth, and GlaxoSmithKline, were questioned about their companies' failure to publicize results of clinical trials showing their drugs were not effective in treating teenagers and children.
  • The companies claim to support a proposal to publicize all clinical trials on a collective Web site, but some committee members argue that a voluntary agreement is not enough and that legislation is needed.

Statistics:

  • In 2002, nearly 11 million prescriptions for antidepressants were given to children in the United States.
  • 2.7 million of these prescriptions were given to children under the age of 12.
  • Thousands of pages of information have been provided by the FDA to the House committee.

Sources:

  • "FDA Accused of Withholding Documents on Antidepressants" by The New York Times, [no date provided]
  • Letter from Representative Joe L. Barton to the FDA, [no date provided]
  • Statement of Jason Brodsky, FDA Spokesman, [no date provided]
  • Hearing of the Energy and Commerce Subcommittee on Oversight and Investigations, [no date provided]
  • Proposal by the Pharmaceutical Research and Manufacturers of America, [no date provided]