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CDC HIV/AIDS/Viral Hepatitis/STD/TB Prevention News Update

UNITED STATES: FDA Urged to Speed Approval of Drugs


Wall Street Journal (09.25.12)

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.


Copyright © 2012 -CDC Prevention News Update, Publisher. All rights reserved to Information, Inc., Bethesda, MD. The CDC National Center for HIV, STD and TB Prevention provides the following information as a public service only. Providing synopses of key scientific articles and lay media reports on HIV/AIDS, other sexually transmitted diseases and tuberculosis does not constitute CDC endorsement. This daily update also includes information from CDC and other government agencies, such as background on Morbidity and Mortality Weekly Report (MMWR) articles, fact sheets, press releases and announcements. Reproduction of this text is encouraged; however, copies may not be sold, and the CDC HIV/STD/TB Prevention News Update should be cited as the source of the information. Contact the sources of the articles abstracted below for full texts of the articles.

Information in this article was accurate in September 26, 2012. The state of the art may have changed since the publication date. This material is designed to support, not replace, the relationship that exists between you and your doctor. Always discuss treatment options with a doctor who specializes in treating HIV.