FDA will issue two new policies on generic reviews at the end of the year, states Gottlieb

In a recent public hearing, Scott Gottlieb, the commissioner of the US Food and Drug Administration (FDA) announced that there will be two new policies to streamline the process for reviewing generic drugs.

The two documents, to be introduced by the end of the year, will be aimed at streamlining the submission and review of abbreviated new drug applications under the FDA’s drug competition action plan, which was confirmed by Gottlieb in a recent article from the Regulatory Affairs Professional Society (RAPS).

The first of these documents will be an internal manual of policies and procedures (MAPP) that will focus on removing any FDA review procedures that are deemed to be redundant and repetitive. The MAPP, ‘Good ANDA Assessment Practices’ should help to streamline reviews, although in the RAPS article, Gottlieb stressed that it will not alter any of the FDA agreed review goals to reauthorize the Generic Drug User Fee Amendments (GDUFA).

“One lesson that we learned from GDUFA and [the Prescription Drug User Fee Act] PDUFA alike is that truncating review prevents applicants from fixing their submissions and getting them approved. The result is additional review cycles, not faster approval. The goal of the MAPP is to help make sure we work smarter,” Gottlieb said.

So, the manual will act as a guide to those who don’t make approval to the areas that need to be fixed in the complete response letter.

The second document will be a guide to ‘Good ANDA Submission Practices’. This will be added to the ‘to-do list’ for the year from the Center for Drug Evaluation and Research — a list that already includes other guides for generic drugs.

Using this guidance to determine common issues in ANDA submissions, applicants can aim to avoid these issues before submitting a generic drug for review, which should improve the rate of approval in the first instance.

In the RAPS article, Gottlieb stated that although he ‘believes improvements within FDA are essential to the success of its generic drugs programme’, applicant should err on the side of caution as the agency can only approve ‘complete submissions that are ready to approve’.