Wednesday, September 26, 2012

FDA Urged to Speed Approval of Drugs

A White House advisory body on Tuesday unveiled a plan to double the number of new prescription drugs that go on the market each year by more quickly approving drugs to treat high-risk patients.
The President's Council of Advisors on Science and Technology urged the Food and Drug Administration to expand its use of faster drug approvals to a wider range of diseases. The council suggested the FDA could begin to approve drugs that may help only a narrow and high-risk patient population, such as people who are morbidly obese, under what the council called "special medical use" approvals.
The advisory report gave few details of what new laws or regulations might be required to limit a new drug's use to such populations. Historically, the FDA doesn't attempt to police how doctors use drugs, though companies' marketing is restricted to the conditions specified on the label.
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