2018 in Generic Drugs: Approvals Shine but Questions Remain on Competition

Regulatory NewsRegulatory News | 28 February 2019 |  By 

The US Food and Drug Administration’s (FDA) Office of Generic Drugs (OGD) this week released its year in review, highlighting another banner year for approvals and new guidance documents.

2018 was the first year of GDUFA II, during which FDA implemented certain new provisions tied to the program and the FDA Reauthorization Act of 2017 (FDARA), including pre-ANDA meetings, reconsideration requests, one-time marketing status updates to the Orange Book and competitive generic therapy designation and exclusivity requests.

“Our 2018 accomplishments included approval or tentative approval of more than 1,000 generic drugs, with record-breaking monthly approval actions in October and November,” said OGD Director Kathleen Uhl, who retired this month and will be replaced by Sally Choe. “First generics (approvals for generic drug products for branded drugs that previously had no FDA-approved generic) made up nearly 10% of 2018’s approvals. Of these first generics,18% were for complex generic drugs while about 14% of all generics approvals were for complex generic drugs.”

Notable first generic approvals in 2018 included those for Mylan’s EpiPen (epinephrine auto-injector), Teva’s Copaxone (glatiramer acetate) and AstraZeneca’s Brilinta (ticagrelor).

Also in 2018, OGD released six draft guidance documents, four final guidance documents and two Manuals of Policies and Procedures (MAPPs). As part of its efforts to be more transparent about the generic drug review process, OGD highlighted the publishing of one draft guidance, known as Good ANDA Submission Practices, detailing common deficiencies in abbreviated new drug applications (ANDAs) that may lead to approval delays.

In addition, OGD issued an accompanying Good ANDA Assessment Practices MAPP outlining ANDA assessment practices from OGD and the Office of Pharmaceutical Quality and formalizing several enhancements to the efficiency of ANDA assessments. 

Competition Questions

But the rising tide of approvals seen at FDA over the past several years comes as a recent Pew Research review found that during the first Generic Drug User Fee Amendments (GDUFA) program, the spike in approvals was “largely driven by approvals of the fourth, fifth, sixth and even later versions of generics,” which tend to have “less of an effect in driving down prices than second and third generics.”

In addition, faster approval times and prioritization of early generic entrants may not be sufficient to spur adequate competition.

“The list of nearly 550 drugs eligible for additional competition may help developers understand market opportunities, but policymakers should examine other options to encourage robust generic development,” Pew adds. “These could include new incentives to submit generic applications to FDA and addressing barriers that may inhibit generic drug development, such as lack of access to samples of the brand drug.”

Seven CEOs told the Senate Finance Committee earlier this week that they would support the CREATES Act, which could improve generic availability.

And a recent report by the Congressional Research Service also suggested that Congress may even go further and consider “explicitly authorizing FDA to require drug price related information as part of an NDA [new drug application], for purposes of approval or otherwise, or to prohibit high drug prices.”

2018 Office of Generic Drugs (OGD) Annual Report


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Tags: EpiPen, generics, OGD

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