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2017 Accelerated the Generic Drug Approval Process


01.02.18

Legislative priorities like a five-year reauthorization of the U.S. Food and Drug Administration’s (FDA) critical medical product user fee programs and other reforms helped accelerate the delivery of safe and effective drugs, devices, and treatments.

H.R. 2430, the FDA Reauthorization Act (FDARA) of 2017, now law, improved the fee structure to support small businesses, and provide goal dates for all outstanding generic drug applications. It also established priority review timelines for generic drugs.

Paired with FDA Commissioner Gottlieb’s goal to eliminate the backlog of generic drug applications and Congress giving FDA greater authority to do so, tremendous strides are being made.

The Washington Post’s The Health 202 Newsletter reports, “Generics were also a priority for Gottlieb’s predecessor, Rob Califf, who was troubled by the massive backlog of generic drug applications, a list that reached longer than 2,800 pending applications in 2012. The backlog is now down to the low 100s, according to Gottlieb, but he wants to essentially eliminate it so companies can obtain immediate review once they apply. …At least in terms of its generic drug goals, the agency ended 2017 with a bang. In October, the FDA announced it had approved 763 generic drug applications so far that year, exceeding previous records of 651 approvals in 2016 and 492 approvals the year prior.”


The Health 202: Generic drugs had a great 2017

… As FDA commissioner, Scott Gottlieb can’t tell drug makers how much to charge for their products, unlike the top officials regulating the drug industry in many other developed countries. But when he was confirmed back in May, Gottlieb identified generics as the space where the agency could potentially have the most impact in the quickest way – both by making it easier for companies to develop generic drugs and nudging generics into markets with no existing competition.

“I think the greatest opportunity to have a very palpable impact on people’s lives is through trying to create greater access,” Gottlieb said in a recent interview with The Health 202. “The low-hanging fruit was on the generic drug side.”

Generics were also a priority for Gottlieb’s predecessor, Rob Califf, who was troubled by the massive backlog of generic drug applications, a list that reached longer than 2,800 pending applications in 2012. The backlog is now down to the low 100s, according to Gottlieb, but he wants to essentially eliminate it so companies can obtain immediate review once they apply.

Part of reaching that goal involves shortening the typical review period, which several years ago averaged as much as 31 months. The FDA has made strides since then, but Gottlieb says he’s aiming for an average review length of just 10 months.

At least in terms of its generic drug goals, the agency ended 2017 with a bang. In October, the FDA announced it had approved 763 generic drug applications so far that year, exceeding previous records of 651 approvals in 2016 and 492 approvals the year prior. …

The agency has promised to expedite review of applications for any drugs on this list, with an eye toward creating more generic choices for consumers who currently have access to only one branded option.

“Hopefully it will have some immediate impact,” Gottlieb said.

Gottlieb said he’s also trying to ease the ability of companies to prove their generic version of an already approved drug is the same as the branded drug they’re trying to emulate. Branded companies often game the system by making it hard for generic companies to buy the 2,000 to 5,000 doses of a drug they need to prove it’s the same makeup.

Gottlieb said he finds the practice so “pernicious” because it undermines the U.S. system of market-based drug pricing.

“We accept the prices, but the flip side of that is we have an expectation that there will be vigorous competition,” Gottlieb said. …

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Health (115th Congress)
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