FDA Unveils Guidance To Smooth Generic-Drug Path

Law360, New York (January 3, 2018, 5:48 PM EST) — The U.S. Food and Drug Administration on Wednesday unveiled draft guidance for the pharmaceutical industry and an internal manual of policies and procedures that it says will streamline the approval process for generic drugs, in part by reducing the number of times an application must be reviewed.

The documents are part of the agency’s Drug Competition Action Plan, which Commissioner Scott Gottleib announced in late May. That plan aims to increase competition and lower drug prices by reducing the ways branded companies can delay generic drugs’ market entry, resolving scientific and regulatory obstacles to generic-drug approval and making the abbreviated new drug application review process more efficient and predictable.

The draft guidance and manual fall under the “efficiency” umbrella, the agency said.

Titled “Good ANDA Submission Practices,” the draft guidance highlights common problems the agency sees in the applications. A key reason for delays is that many ANDAs must be reviewed multiple times and usually that’s because the application lacks enough scientific evidence to support approval, but it could also be because the FDA needs to ask for more information, the agency said.

On average, an ANDA endures four review cycles before it’s approved, not necessarily because it doesn’t meet FDA standards, but often because it’s missing necessary information, the agency said.

Repeated reviews are costly and inefficient, requiring a lot of avoidable work by agency staff and applicants, and the FDA said Wednesday that the draft guidance aims to help reduce the number of times an ANDA must be reviewed before a decision is made.

The categories of ANDA deficiencies listed in the draft guidance include labeling problems and product quality issues.

The manual of policies and procedures, meanwhile, outlines ANDA assessment practices used by FDA staff. For example, it says that when the FDA determines an application can’t be approved as is, staff should more thoroughly explain application deficiencies to the applicant, outline how more information should be provided and, when possible, say what information is necessary to support approval during the next review.

The goal of this document, which doesn’t alter regulatory requirements for ANDA approval, is to make generic-drug makers fully aware of problems delaying approval of their application and to help them understand how to fix them. By doing so, it should also reduce the number of times an ANDA has to be reviewed, the FDA said.

The agency said Wednesday it plans to take more steps this year to promote competition, reduce drug prices and improve access to medication, such as making it harder for brands to use certain tactics aimed at preventing generics from entering the market.

Those tactics include potential abuses of the citizen petition process, restricting access to testing samples of branded drugs and abuses of the “risk evaluation and mitigation strategies,” or REMS, process, the agency said.

REMS, which is used to ensure the safe distribution and prescribing of potentially dangerous drugs, has been used by brand-name drugmakers to withhold samples necessary for generic-drug testing and some branded companies have delayed setting up shared REMS systems with generic-drug makers. In November, Gottleib told the brand-name drugmakers to “end the shenanigans” involving REMS.

Pharmaceutical trade groups have said that they’re concerned about the disclosure of confidential commercial information via REMS and with the implication that they’re improperly withholding samples.

They’ve also said that a proposal by Amneal Pharmaceuticals LLC to let generic-drug makers use non-U.S. samples of branded drugs to demonstrate that their versions are the same raises legal, scientific and safety concerns.

–Additional reporting by Jeff Overley and Kyle Jahner. Editing by Orlando Lorenzo.

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