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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.
The Friends of AIDS Foundation is
dedicated to enhancing the quality of life for HIV positive individuals and
empowering people to make healthy choices to prevent the spread of the HIV
virus. To learn more about The Friends of AIDS Foundation, please visit: http://www.friendsofaids.org.
TOGETHER WE REMAIN STRONG!
