Generic drug reviews have gotten faster. Here’s why

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Alexander Gaffney Senior Manager, Health Research Institute, PwC US October 26, 2018

The FDA is approving generic drugs faster than ever. But what’s driving the increase in approval speed, and what does it mean for the pharmaceutical industry?

New authority, faster approvals

  • Under the FDA Reauthorization Act (FDARA), certain generic drugs are now eligible for “priority review” if they meet the criteria, reducing review time by two months for full applications and most application amendments and post-approval changes, according to an analysis by PwC’s Health Research Institute (HRI).

HRI also found:

  • As recently as fiscal year 2016, the FDA’s review goal for full generic drug applications, known as Abbreviated New Drug Applications (ANDAs) was 15 months. It can now be as short as eight months.
The FDA has introduced expedited reviews for priority generics
Why generic drug reviews are faster
  • But while that goal tracks only “FDA time”—the time an application is being reviewed by the FDA, minus time spent by a company responding to FDA comments or concerns—overall review times in fiscal year 2018 are dropping as well, to 32.2 months in the second quarter from 41.7 months in the first.
  • The FDA also has released large amounts of product-specific guidance documents which are helping companies to establish exactly what regulators need to establish bioequivalence between a generic and the reference drug – a key standard required for generic approval. The FDA published 719 of these documents since the start of 2013.
  • The FDA has eliminated a backlog of applications and correspondence that had left many generic drugs waiting months, and even years, to be reviewed by the agency.
FDA has eliminated backlog for filing generic drug applications
FDA has eliminated generic app backlog

FDA’s generic approvals process is streamlined

Cumulatively, changes made by the FDA have resulted in substantial benefits for the generics industry, including faster approvals, new exclusivity, new staff with which to review applications and new guidance documents. A comparison by HRI of the last five years shows just how substantial those changes have been.

As the full effects – and funding – of FDARA come into effect, the FDA is likely to continue to approve record or near-record numbers of generic drugs.

The FDA has made significant changes to its generic approvals process
Generic drug reviews have gotten faster

For more information

To read more about how the FDA is speeding up generic drug approvals and what it means for the pharmaceutical industry, please read HRI's report, Is new generic competition enough to lower drug costs?

Contact us

Alexander Gaffney

Senior Manager, Health Research Institute, PwC US

Tel: +1 (202) 836 1604

Benjamin Isgur

Health Research Institute Leader, PwC US

Karla Anderson

Principal, PwC US

Dinkar Saran

Principal, Health industries Advisory Services, PwC US

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