The President’s Council of Advisors on Science and Technology unveiled a plan to double the number of new prescription drugs available by expediting the approval process of drugs to treat high-risk patients. The council urged the US Food and Drug Administration (FDA) to use faster drug approvals for a wider range of diseases, and suggested that the FDA begin to approve drugs that may benefit a limited high-risk patient group under what is termed “special medical use” approvals.
The report provided few details of new laws or regulations that might be necessary to limit a new drug’s use to special populations. The FDA does not police how doctors use drugs, but companies marketing the drugs are restricted to the conditions on the label. Since the 1990’s, the FDA has used its “accelerated approval” program for certain drugs such as drugs for the treatment of AIDS and cancer. The council suggested that the FDA could expand its use of accelerated approval to cover a greater variety of serious diseases with unmet medical need. The FDA shortened review or expedited approval for 16 of 35 drugs it considered “innovative, during fiscal 2011.
Top officials at the FDA have said they are working to reduce the red tape required for drug approvals.
Date of Publication
Thomas M. Burton
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