FDA faces US House on VA drug oversight

The US Food and Drug Administration has provided an analysis of the agency's role in identifying and communicating drug safety issues, in evidence to a meeting of the House of Representatives Committee on Veterans' Affairs. The federal agency was called upon to provide testimony at a hearing in Washington, DC, titled, Why Does the [Veterans Administration] Continue to Give a Suicide-Inducing Drug to Veterans with Post-Traumatic Stress Disorder?

FDA admits regulation is not enough

Presenting a statement to the Committee was Paul Seligman, Associate Director of Safety Policy and Communication at the FDA's Center for Drug Evaluation and Research. In the course of his presentation, Dr Seligman outlined some of the agency's initiatives to ensure the safety of medicines, including some that are new or only recently adopted. He also provided details of the FDA's management of drug safety issues and communications strategy. In conclusion, however, Dr Seligman admitted that, "while a broad set of protections are built into the law and regulations, the professional and ethical conduct of the parties involved in clinical research is crucial to the protection of human subjects."