FDA head renews push for generics competition

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FDA head renews push for generics competition

By Sandra Levy - 01/31/2019
Food and Drug Administration commissioner Scott Gottlieb is continuing to take up the mantle of his initiative to increase competition in the generics market. Gottlieb this week has outlined steps the agency will take in 2019 to continue to promote generic competition for complex drugs.

Gottlieb said the agency plans to issue guidance documents on the development of specific complex generics, as well as address hard-to-copy complex drugs that have difficult to replicate formulations or delivery modes. He said this would include guidances addressing the difficult of developing complex generics and establishing standards for "active ingredient sameness. Gottlieb went on to say the agency will help advance the development of new analytical tools and in vitro tests that may provide additional accurate, sensitive and reproducible tools to support approval of complex generic drugs. "Better tools can reduce complex generic drug development time and cost and can inform regulatory decisions," Gottlieb said.

He said that these new policy efforts are aimed at ensuring "that we provide as much scientific and regulatory clarity as possible with respect to complex generic drugs. This focus is critical because, first and foremost, these drug products provide important therapies to patients. We believe that they’re also becoming increasingly important to the economic stability of the generic drug industry. Being able to ‘genericize’ a complex medicine can be a high-value opportunity for a generic drug developer."

Gottlieb also issued a new draft guidance to ensure the utility of the FDA publication Approved Drug Products with Therapeutic Equivalence Evaluations Publication, which is also known as the Orange Book. Generic makers use the book to help plan their development efforts.

“We want to make sure it provides as much utility as possible to aid manufacturers as they allocate resources towards the development of new generic drug products,” said Gottlieb.

Another draft guidance — "Marketing Status Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic Act; Content and Format," is providing approved drug application holders clarity on the specific categories and descriptions of the information they’re required to share with FDA on the marketing status for their brand and generic drugs. It also outlines how to provide the information in a timely and consistent manner.

"Having timely, accurate information about what drugs are being actively marketed helps provide transparency around circumstances where generic competition is lacking. It helps us also better understand circumstances where generic medicines are being approved, but not marketed so that we can better consider any policy reasons why this may be occurring," Gottlieb said.

The FDA will be soliciting public comment on Orange Book use and potential enhancements, including a reexamination of what pharmaceutical patents should be listed in the Orange Book.

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