FDA to establish new drug safety boardThe FDA will establish a new independent Drug Safety Oversight Board to improve the monitoring of medicines already in the marketplace and update physicians and consumers with information on risks and benefits.
Health and Human Services secretary Mike Leavitt made the announcement in a meeting with FDA employees earlier today.
Comprised of representatives from the FDA and medical oversight experts from other agencies like the Veterans Administration, the board will consult with patient and consumer groups and recommend what information and updates are put on the government's Drug Watch Web site.
The board's recommendations for new warning labels or a drug's withdrawal from the market would go to the FDA's Center for Drug Evaluation and Research for consideration, acting FDA commissioner Lester Crawford told reporters.
The creation of the board follows criticism in recent months that the FDA was slow in reacting to reports linking Vioxx and Celebrex to increased heart risks.
The Office of Drug Safety, which has been criticized by consumer groups and legislators as lacking sufficient resources, will also continue watch for problems with drugs after their approval.
The Bush administration proposed a 24 percent increase in funding for the office in its recent 2006 budget request sent to Congress, including 25 additional employees.