U.S. Food and Drug Administration said on Friday that it plans to conduct an in-depth evaluation of its approach in detecting, assessing, managing and communicating the risks and benefits of prescription and over-the-counter drugs.

Dr. Lester Crawford, acting F.D.A. commissioner, authorized the Center for Drug Evaluation and Research (CDER) to sponsor the Institute of Medicine to study the drug safety system with emphasis on the post-market phase, and assess what additional steps could be taken to learn more about the side effects of drugs as they are actually used.

The committee will examine FDA’s role within the health care delivery system and recommend measures to enhance the confidence of Americans in the safety and effectiveness of their drugs.

In addition, the F.D.A. will implement a program to provide an improved process to ensure that the opinions of scientific reviewers are incorporated into its decision-making process.

The F.D.A also said it will publish by the end of the year final versions of three guidances that have been developed by the agency to help pharmaceutical companies manage risks involving drugs and biological products. These documents, which were first issued as draft guidances in May 2004, are designed to assist manufacturers in the management and minimization of risks of pharmaceutical products throughout their life cycle.

These documents are “Premarketing Guidance,” covering risk assessment of pharmaceuticals prior to their marketing; “RiskMAP Guidance,” which deals with the development and use of risk-minimization action plans; and “Pharmacovigilance Guidance,” which discusses post-marketing risk assessment, good pharmacovigilance practices and pharmacoepidemiologic assessment.

“I am satisfied that these additional activities will strengthen the agency’s program to greater ensure the safety of medical products that are making a major contribution to the health and quality of life of millions of Americans,” Dr. Crawford said.

(via U.S. Food and Drug Administration)