Position
In September of 2006, the Institute of Medicine (IOM) released a report on the future of drug safety and the role the FDA plays in this process. The IOM report was issued in response to growing concerns over the health risks posed by some FDA-approved drugs. This report highlighted many areas for potential policy change. The Alliance for Aging Research agrees that there is a need to reexamine the current drug approval process so that patients have access to new treatments as quickly as possible.
The Alliance supports policy change with respect to drug safety focused in the following areas:
- enhancing the FDA’s post-approval authority to work with industry, doctors, and patients to communicate what is learned about products once they have been introduced into the practice of medicine;
- increasing the FDA’s authority to regulate and enforce how drugs enter the marketplace with respect to the communication of the benefits and risks posed by new medications;
- ensuring that the FDA has the capabilities to make safety and efficacy information more patient-centered;
- increasing the amount of annual appropriations for the FDA to make the agency less dependent on industry user fees.
