Wednesday, October 3, 2012

Report Urges FDA to Approve More Drugs


By David Pittman, Washington Correspondent, MedPage Today

WASHINGTON -- The FDA should set a goal of doubling the number of new drug approvals over the next 10 to 15 years and can approve products for smaller populations to do so, White House advisers said.
The agency can approve drugs with a narrower indication for which a drug is safe and effective, and protect a broader population from unknown or unfavorable risks, the President's Council of Advisors on Science and Technology (PCAST) said in a 110-page report.
"It would require a special designation that would strongly discourage prescribers from using these drugs off-label and discourage payors from reimbursing off-label use," stated the report, Propelling Innovation in Drug Discovery, Development, and Evaluation, released last week.
Off-label use "has contributed to discoveries of useful applications of drugs to non-approved uses, but it can also pose serious risks to patients," PCAST said.
The report follows President Obama's request to examine ways to improve the drug development and review process. Many advancements in biomedical research haven't translated to new medicines for the betterment of public health, the council said.
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