Generic Drug Approvals Hit Another Record High as Competition, Quality Questions Linger

Regulatory NewsRegulatory News | 16 August 2019 |  By 

Another year, another record number of generic drug approvals and tentative approvals for the US Food and Drug Administration (FDA).

This has been the story at FDA from FY 2016 to FY 2017 to FY 2018 and now to FY 2019, with two months to spare.

But questions remain on whether these approvals are actually translating into greater competition and lower costs for patients. A report from Pew earlier this year found that the increase in approved generic drugs from 2013 to 2017 was largely driven by approvals of the fourth, fifth, sixth and even later versions of generics. And costs generally decline most significantly once second and third generics enter the market.

Robert Pollock, senior advisor to Lachman Consultants, explained to Focus that it can be difficult to assess how the approvals translate into competition because it can take up to five years for approved generic drugs to launch. One would think that following approval, firms would be chomping at the bit to launch, but that is apparently not the case, he said. Delays may also be mediated by changing portfolio priorities, the importance of one product over another or mergers and acquisitions, Pollock added.

And as the approval numbers increase, the number of complete responses sent to generic drugmakers has also held steady over the past few years, signaling that generic drugmakers still need to go through multiple cycles of FDA reviews before winning approvals. Complete responses in FY 2019 have already totaled 1955, which compares with 2648 in FY 2018 and 1603 in FY 2017.

The number of first generics approved can also serve as a bellwether for the progress in innovation among the generic industry. So far this year, FDA has approved 73 first generics, which compares similarly with a total of 99 first generics in 2018, 80 in 2017 and 73 in 2016.

On the positive side, FDA has begun to optimize its utilization of programs that expedite certain abbreviated new drug application (ANDA) approvals, with an increase in approvals for those with competitive generic therapy (CGT) designations, from just three in FY 2018 to nine so far in 2019. Priority review ANDAs are also seeing increases in submissions.

But recent international investigations into impurities in angiotensin II receptor blocker (ARB) drugs and congressional questions on FDA’s work to inspect manufacturing plants overseas has the agency and generic industry on edge.

“It’s not enough to bring more generics to market, consumers must also have confidence in the safety and quality of generic medicines. Through our review and approval process, we help ensure the safety, effectiveness and quality of all FDA approved generics,” Acting FDA Commissioner Ned Sharpless said recently while announcing the record-breaking year in ANDA approvals.


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