FDA Guide Won’t Stop Brand Drugmakers From Delaying Generics

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By Bronwyn Mixter

The FDA’s new draft guidance on shared risk evaluation and mitigation strategies (REMS) does little to stop branded drug companies from using REMS to delay generic competition.

The new draft guidance describes how branded-drug and generic companies can use a single electronic drug master file for submitting a shared REMS. The draft guidance is intended to streamline the submission and review process for shared REMS systems. The agency sometimes imposes a REMS on a drug to ensure its benefits outweigh its risks.

The new process would eliminate duplicative paperwork for sponsors, and would decrease the volume of forms the FDA’s reviewers must access, Food and Drug Administration Commissioner Scott Gottlieb said in an announcement.

Branded and generic manufacturers of the same product are legally required to reach agreement on a single, shared REMS system rather than implementing separate REMSs. However, branded drug companies sometimes extend these negotiations as a way to slow generic competitors from reaching the market.

Anything that reduces the burden on generic manufacturers will be helpful, and the draft guidance is a step toward making it easier for branded and generic manufacturers to reach agreement on a shared REMS, Tom Kraus, senior vice president at Avalere Health, told Bloomberg Law Nov. 13.

But, he said, the draft guidance doesn’t obligate anyone to use a common master file for REMS submissions. Kraus served as chief of staff at the FDA before joining Avalere.

Ameet Sarpatwari, an instructor at Harvard Medical School, also told Bloomberg Law the draft guidance “is a helpful step in terms of improving efficiency,” but it doesn’t tackle how brand-name companies are able to use the requirement for a shared REMS to delay generic drugs.

Other Delay Tactics

Sarpatwari said branded drug companies use a couple of different strategies associated with REMS to delay generics.

One is the branded drug company delays generic entry through the shared REMS requirement. Another is that companies use REMS to delay generic drug launches by refusing to provide generic companies with drug samples needed for bioequivalence testing, Sarpatwari said. Sarpatwari also is an associate epidemiologist at Brigham and Women’s Hospital, and assistant director of the Program On Regulation, Therapeutics, And Law (PORTAL) within the Division of Pharmacoepidemiology and Pharmacoeconomics.

Deborah Shelton, a pharmaceutical law attorney, told Bloomberg Law in a Nov. 14 email the draft guidance “is not likely to have a significant effect on resolving issues of use of REMS to impede generic and biosimilars access” to branded drug samples. Biosimilars are less expensive versions of biologic drugs.

“As a general matter, drug master files would help to facilitate shared REMS without disclosing another entity’s trade secret information, and also helps to make multiple REMS more manageable via consolidation, but I do not see either of those improvements as getting at the overarching access issue,” Shelton said. Shelton is with McCarter & English in Washington, and a Bloomberg Law advisory board member.

Other Steps FDA Is Taking

Gottlieb said the FDA also is exploring steps it can take to reduce the likelihood that branded drug companies can use REMS to slow generic competitors.

The FDA “has commendably seen that there’s a problem here” and is taking steps to remedy it, Sarpatwari said. For example, in the previous administration, the FDA said it would provide letters assuring the safety of potential testing protocols so that branded drug companies would provide samples to generic companies, he said.

“Those are helpful steps in the case where somebody is legitimately worried that safety is the issue, but often times safety is the pretext for just preventing competition,” Sarpatwari said.

However, Sarpatwari said, without congressional action, the FDA can’t compel branded companies to provide samples. He said H.R. 2212, the Creating and Restoring Equal Access to Equivalent Samples Act of 2017 (CREATES Act), would fix some of the issues with REMS.

The CREATES Act would create a cause of action in federal courts for a generic manufacturer to obtain sufficient samples to perform bioequivalency studies. It also would make it easier for a generic drug to get FDA approval for a separate REMS program.

Generic Industry Weighs In

David Gaugh, a senior vice president at the Association for Accessible Medicines (AAM), said in a Nov. 13 statement provided to Bloomberg Law the draft guidance “is one of the steps the agency is taking under Dr. Gottlieb’s Drug Competition Action Plan to help eliminate the avenues brand companies are using to prevent generics access to the market on the first legally eligible date of entry.”

Gottlieb announced the Drug Competition Action Plan in June.

A notice announcing the draft guidance was published in the Nov. 9 Federal Register (82 Fed. Reg. 52,058). Comments are due Jan. 8, 2018 (Docket No. FDA–2017–D–6231).

To contact the reporter on this story: Bronwyn Mixter in Washington at bmixter@bna.com

To contact the editor responsible for this story: Brian Broderick at bbroderick@bna.com

For More Information

The draft guidance is at http://src.bna.com/ucT.

Copyright © 2017 The Bureau of National Affairs, Inc. All Rights Reserved.

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