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A FASTer FDA?

A new bill recently debated in the US Congress seeks to streamline the approval process for drugs.

By | March 19, 2012

WIKIMEDIA COMMONS, TIBOR KADEK

The Faster Access to Specialized Treatments (FAST) Act made its debut on the floor of the US House of Representatives earlier this month. The bill is seeking to extend fast-tracked drug approvals beyond HIV/AIDS and cancer drugs, which already benefit from legislation that have increased investment, shortened timeframes, and decreased burdens of proof for garnering US Food and Drug Administration approval.

The FDA is cautioning patience because in order to accelerate the approval of drugs that treat Parkinson's, Alzheimer's, diabetes, and other diseases, scientifically meaningful clinical endpoints must first be established to ensure that the right safety and efficacy data is be submitted and evaluated. "We agree with the sentiment behind [the FAST Act] but have to avoid inadvertently lowering the efficacy standard," said director of the FDA's Center for Drug Evaluation and Research Janet Woodcock at a Congressional subcommittee hearing on last Thursday (March 8).

But John Maraganore, CEO of Alnylam Pharmaceuticals, told the same subcommittee that the benefits of the FAST Act could be great when those endpoints are agreed upon and can consistently be measured to demonstrate a reasonable likelihood of clinical benefit. "If the accelerated approval pathway is modernized, and that is reduced to actual practice so people can see it, you can logically expect investors to feel more bullish about investing in biotech," Maraganore told BioCentury. "As a result, I would expect more investment in breakthrough medicines, and more medicines coming into the pipeline that would take advantage of the accelerated or traditional pathways."

The FAST Act will be further debated by the House of Representatives, and the ideas it contains could be absorbed into the Prescription Drug User Fee Act (PDUFA) V, which expires in September and is expected to be reauthorized.

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