Regulatory Focus™ > News Articles > Report: FDA Considering New Approval Paradigm for Socially Beneficial Drugs

Report: FDA Considering New Approval Paradigm for Socially Beneficial Drugs

Posted 12 October 2012 | By

The US Food and Drug Administration (FDA) is considering allowing sponsors of select therapies to conduct smaller, faster clinical trials in return for a more restrictive labeling convention that would initially limit its use to a narrower group of patients, FDA Commissioner Margaret Hamburg told a group of scientific advisors.

The remarks, reported by Bloomberg, potentially mark a paradigm shift for FDA, which has historically granted marketing licenses for new products based on wider approvals with the understanding that once approved, products are typically prescribed off-label for a variety of uses that do not necessarily comport with their approved labeling.

Under the new fast-track proposal-still very much hypothetical-some obesity, antibiotic and other socially beneficial drugs would be given a "special medical use" label, allowing doctors to prescribe or administer the drugs to select patients without having to worry about them being used in populations less likely or uncertain to benefit from their use.

"This is an issue of having the right science and data to assess risks and benefits but also a broader societal discussion about risks and benefits that individuals and communities are willing to take on and under what circumstances," Hamburg said, reports Bloomberg.

FDA would need new legislative authority to allow it to establish both the pathway and any restrictions, which could run into pressure from physicians' groups such as the American Medical Association (AMA) if they establish limits a physician's ability to prescribe a particular course of treatment for a patient.

Still, the proposal could be a win-win for regulators, industry and patients alike. Regulators could ease some pressure from industry, which frequently complains that FDA is too slow to approve some drugs with variable risk profiles. Industry could see faster returns on investment for some drugs, allowing it to spend less money for partial approval. Patients, meanwhile, could receive more expeditious access to new therapies, particularly if they are in a high-need category.

Hamburg said FDA would require sponsors to generate additional data to expand the labeling for a "special medical use" product, but details of the plan remain unsettled.


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