IOM Report Confirms FDA Lacks Power to Enforce Drug Regulations, Says DeLauro

IOM Report Confirms FDA Lacks Power to Enforce Drug Regulations, Says DeLauro

Congresswoman Rosa L. DeLauro (Conn.-3) today issued the following statement on a new report released by The Institute of Medicine (IOM) entitled, The Future of Drug Safety.

"This report confirms what many of us in Congress have been arguing all along - that the Food and Drug Administration's (FDA) authority must be strengthened to empower the agency to take rapid and decisive actions on drug safety.

"The report concludes that the FDA lacks the authority to enforce drug companies to comply with regulatory requirements, and that the agency relies too much on negotiations with industry. The IOM also noted that the user-fee program emphasizes speed of approvals and is insufficiently attentive toward drug safety.

"This report provides independent verification that Congress must act to implement the changes that need to be made at the FDA. Congress should particularly heed IOM's recommendation that specific safety-related performance goals be included in the PDUFA reauthorization bill in 2007."

The recommendations outlined in the by IOM report reflect several initiatives proposed or supported by DeLauro, including:

· Ensuring that FDA has the ability require post-market surveillance to monitor and ensure the safe use of drug products;

· Requiring a moratorium in direct-to-consumer advertising, and specific warnings to be incorporated into all promotional materials for prescription drugs; and

· Eliminating conflict-of-interest involving members of FDA advisory committees.

http://www.house.gov/delauro/press/2006/September/FDA_Drug_Regulations_09_22_06.html