Aiming for more copycats of each branded drug, FDA expands generic drug priority reviews

Talk of bringing down the price of pharmaceuticals often hinges on generic competition, and the US is seeing approvals of new generic drugs faster and more consistently than ever — a trend likely to continue.

The progress comes as FDA commissioner Scott Gottlieb on Thursday indicated that the agency will expand which abbreviated new drug applications (ANDA) will see priority reviews.

“Earlier this year we made changes to how we prioritize the agency’s generic drug submissions. The goal was to prioritize the review of generic applications until the FDA has approved three generic versions of each particular drug,” Gottlieb said in a statement. “Today we’re expanding this competition-focused policy to prioritize any application that can meet the FDA’s approval standards at the point when the 180-day exclusivity period expires on a first generic entrant to a branded medicine.”

The shift could accelerate generic competitors to market more quickly and help bring down costs, and comes a day after the Federal Trade Commission held a workshop on drug competition.


2017 saw the highest number of ANDA approvals in one fiscal year ever, and that followed a similarly record-breaking 2016.

But those record years of approvals do not seem to be slowing. A look at the FDA’s latest generic drug review dashboard reveals the number of ANDAs pending review at the agency has still increased over the last 10 months.

As of 1 January 2017, FDA’s generic drug review dashboard noted that 2,358 applications are still with FDA and either pending filing review, filed with no review communications or have had at least one review communication issued.

But there are now 140 more applications pending with FDA than there were to start the year, according to the latest review dashboard as of 1 October 2017. However, the number of applications with industry (either pending a response or receiving tentative approval) has fallen over the same period by 116 applications.

Robert Pollock

On whether there might be a new backlog forming at the agency, former FDA deputy director of the Office of Generic Drugs Robert Pollock, who is now a senior adviser with Lachman Consultants, told Focus: “As long as the number of receipts is greater than the number of approvals [the number of ANDAs with FDA] won’t change.”

“I do expect the number of approvals to rise modestly over the next two years and then if it does not dramatically improve after that, then something is drastically wrong,” Pollock said.

Part of that increase of applications awaiting FDA’s action is due to an uptick in requests during review for further information or clarifications, though the number of ANDAs pending filing review declined by 40 applications over those 10 months and the number of ANDAs filed with no review communication fell by 100 ANDAs in the same period.

As FDA hit its ANDA backlog reduction in 2016 under the first Generic Drug User Fee Amendments (GDUFA), how the agency stays the course or shifts its workload under the second iteration of GDUFA will be important to track, especially with more priority reviews for ANDAs coming.

Image: Scott Gottlieb in front of Congress earlier this year AP Images

First published here. Regulatory Focus is the flagship online publication of the Regulatory Affairs Professionals Society (RAPS), the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products. Email news@raps.org for more information.

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