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House Committee Quizzes FDA on Complex Generic Drugs

Posted 20 January 2020 | By Zachary Brennan 

House Committee Quizzes FDA on Complex Generic Drugs

A bipartisan group of House Energy & Commerce Committee leaders last Friday sent a letter to US Food and Drug Administration (FDA) Commissioner Stephen Hahn seeking information on the agency’s efforts to approve complex generic drugs more quickly.

The congressmen said they are trying to understand if FDA needs additional authority to improve the approval process for complex generic drugs, which can be more difficult to formulate or manufacture than other generic drugs. As an example of a complex generic drug that was approved slowly, the letter points to the first generic version of the EpiPen, which was approved 10 years after the abbreviated new drug application (ANDA) was submitted.

"The length of time leading to the approval of some recently approved complex generics raises questions of whether additional actions may be necessary to encourage the development of these products," the committee members wrote.

The letter also notes a Government Accountability Office (GAO) report from January 2018 in which FDA was asked to provide more guidance to industry on complex generics. GAO found that FDA approved generic versions of five of 28 drugs identified as complex generics prior to fiscal year 2017 and considered a range of data when assessing equivalence to the relevant brand-name drug.

The report came a few months after former FDA Commissioner Scott Gottlieb pledged to release more complex generic guidance, after releasing a document on meetings between FDA and complex generic applicants. In October 2018, the agency also released one revised draft guidance and another new draft guidance to help advance the development of generic transdermal and topical delivery systems.

Looking ahead, the E&C members requested that FDA provide them with the following information:
  • A list of all complex generic drugs approved by FDA since 1 October 2016, including the date of the first submission, the dates of other milestones (e.g., issuance of complete response letters [CRLs], subsequent submissions) and the date of approval.
  • Copies of any after-action reports or internal reviews related to the review process of complex generic drugs approved since 1 October 2016.
  • The number of pre-ANDA meeting requests that FDA has received each year since the program was launched, the number of pre-ANDA meetings that FDA has held each year and the number of ANDAs that have been submitted for products discussed during these meetings. 
  • The number of product development meeting requests for complex products, as defined in the GDUFA II commitment letter, that FDA has received each year since 1 August 2017; the number of product development meeting requests for complex products that FDA has held each year; and the number of ANDAs that have been submitted for products discussed during these meetings.
  • A list of product-specific guidances FDA has published for complex drug products, including the number of such guidances that are draft and the number of such guidances that are final.
Letter

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