WASHINGTON (CNN) - In light of the recent recall of Vioxx and the controversy over the connection between antidepressants and child suicides, the Federal Drug Administration on Friday announced a five-step program aimed at improving its method of assessing risks connected with drugs.
These steps would include an independent review of the drug system.
"Detecting, assessing, managing and communicating the risks and benefits of prescription and over-the-counter drugs is a highly complex and demanding task," the FDA's acting director, Dr. Lester Crawford, said in a written statement.
"(The) FDA is determined to meet this challenge by employing cutting-edge science, transparent policy and sound decisions based on the advice of the best experts in and out of the agency."
Step one, he said, is to ask the Institute of Medicine to conduct an independent review of the entire drug safety system, with particular emphasis on how the FDA looks at drugs after they are put on the market. It will be asked to "assess what additional steps could be taken to learn more about the side effects of drugs as they are actually used," the FDA statement said.
The Institute of Medicine will be asked to recommend "measures to enhance the confidence of Americans in the safety and effectiveness of their drugs."
The second step is to improve the process of making sure the opinions of all scientific reviewers are incorporated into the decision-making process on drugs, the statement said.
When faced with differing opinions from scientists inside and outside the agency, an ad hoc committee will be formed to review the matter and make recommendations.
Third, a new director of the Office of Drug Safety will be appointed as soon as possible. The position has been vacant since October of last year.
Fourth, drug safety and risk workshops will be held to discuss "complex drug safety and risk management issues."
Finally, guidelines are being drawn up "to help pharmaceutical firms manage risks involving drugs and biological products."
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