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New Drug Approvals Surge.

WASHINGTON -- New drug approvals by the Food and Drug Administration climbed to a 21-year high in 2017.

The FDA gave the green light for 46 new molecular entities (NMEs) last year, more than double the 22 NMEs cleared for market in 2016, when approvals had dropped from 45 in 2015 and 41 in 2014.

Those totals compare with the 18 to 39 NME approvals annually going back from 2013 to 2005, according to the Regulatory Affairs Professionals Society (RAPS). Still, the record year for approvals was 1996, when 53 NMEs were cleared by the FDA, RAPS noted.

The first and last quarters of 2017 saw the most NME approvals, with 12 apiece. Many of the medicines approved during the year were for rare diseases and subtypes of cancer, which can target small patient populations and cost hundreds of thousands of dollars. In total, there were 14 approvals for cancer drugs.

President Trump made pharmaceuticals a focus area early in his administration, saying he not only aimed to deflate ballooning drug prices but also remove competitive hurdles and unfurl regulatory snags to expedite approvals of new medications. Charged with achieving those objectives --especially cutting red tape to get new drugs to market faster--is Scott Gottlieb, who was sworn in as the FDA's new commissioner in May.

Gottlieb wasted no time and started off by focusing on lower-cost generic drugs. In late May, he announced the Drug Competition Action Plan. The FDA said the three-pronged plan aims to reduce gaming by branded drug companies that can delay generic entry; resolve scientific and regulatory obstacles that can hamper approvals of generic versions of certain complex drugs; and improve the efficiency and predictability of the FDA's generic review process. Specifically, the latter seeks to reduce the time it takes to get a new generic approved and lessen the number of review cycles of generic applications before they can be approved.

Earlier this month, the FDA released two documents to improve the submission and review of Abbreviated New Drug Applications (ANDAs) for generics. The first, "Good ANDA Submission Practices," highlights common, recurring deficiencies in generic applications that may lead to a delay in their approval. And as a companion to the guidance, the FDA published "Good ANDA Assessment Practices," a manual that formalizes a more streamlined and efficient generic review process for FDA staff.

"The FDA's generic drug team already has made substantial investment in process improvements that are yielding faster assessment and approval times, translating to direct benefits for consumers through more approvals of lower-cost drug options," Gottlieb stated. "In 2017, we had several record-breaking months for the number of generic medicines approved in a single month, most recently in November, when we approved the highest number of generic medicines in the FDA's history. For the full year, the FDA approved a record number of generic drugs, including first generics, high-priority medications and drugs meeting vital public health needs.

"In addition to the increase in the volume of drugs being approved, the average number of review cycles needed to approve each eligible application is decreasing," he noted. "The FDA took action on more applications in the last six months of 2017 than any other six-month period in FDA history."

Caption: Scott Gottlieb, FDA commissioner
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Title Annotation:Focus
Publication:Chain Drug Review
Date:Jan 15, 2018
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