Balancing Hatch-Waxman: Stakeholders Weigh in After FDA’s Meeting

Posted 20 September 2017 By Zachary Brennan

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Following a US Food and Drug Administration (FDA) meeting in July on generic drug competition, various stakeholders are offering written comments on reforms FDA and Congress could make to ensure the Hatch-Waxman amendments are not abused.

Like others, California Attorney General Xavier Becerra submitted comments calling for pay-for-delay agreement reforms, including legislation to make the deals "presumptively unlawful," reforms to FDA’s citizen petition process and added restrictions on brand name drug companies’ ability to use risk evaluation mitigation strategies (REMS) to delay generic drug competition.

Becerra said he supports a recommendation made by Rutgers Law School Professor Michael Carrier that REMS patents not be eligible for listing in the Orange Book, among others. FDA Commissioner Scott Gottlieb has said recently FDA will release letters sent to branded companies when they abuse REMS to block generic competition, though Lachman Consultants questioned whether the release of such letters will have an impact. At the meeting in July, Gottlieb also said a MAPP and guidance would be released to improve the generic drug review process.

Agreeing with Becerra on the call to reform citizen petitions is CVS Health, which said in its comment that about 92% of all citizen petitions (which originally were meant for citizens to bring concerns directly to FDA) are filed by brand name drug manufacturers.

"CVS Health recognizes that FDA is primarily responsible for safety, and is not equipped to police the abuse of citizen petitions. Therefore, we recommend that FDA refer all drug manufacturers suspected to be abusing citizen petitions to the Federal Trade Commission (FTC)," the comment adds.

The issue of complex generic drugs (an area where Gottlieb has suggested policy changes) was raised in Vifor Pharma’s comment, which offered several approval examples "despite the fact that, in 2014, FDA explicitly acknowledged that ANDAs [abbreviated new drug applications] for complex drug products are controversial, are more work than other ANDAs, and demand novel thinking about equivalence."

Bruce Leicher senior VP and general counsel at Momenta Pharmaceuticals, called on FDA to use carryover funds from the first iterations of the Generic Drug User Fee Amendments and Biosimilar User Fee Agreement to hire, train and deploy new staff "to handle the rapid growth in meetings and applications occurring in CDER for biosimilar applications and in OGD for generic drugs."

Leicher also encouraged FDA to fully adopt its proposed rule on biosimilar and biologic naming so that biosimilars are not approved with a suffix while reference biologics are approved without one (as has been the situation since the first biosimilar was approved by FDA).

"As noted by the Agency in the guidance, equal treatment is important to ensure that the naming policy does not raise consumer or physician concerns about the safety or efficacy of biosimilars," Leicher wrote. "Moreover, the failure to require a suffix for all biologics eliminates or significantly reduces the incentive to re-program electronic medical record and pharmacy systems to accommodate a few biosimilar approvals."

Several of the reforms suggested in the comments are contained in a bill known as the CREATES Act, which a coalition of stakeholders called for its adoption in a letter to both the Senate and House leaders on Tuesday.

On the other side of the debate, Celgene and Eli Lilly called the Hatch-Waxman amendments "a tremendous success" and "one of the most successful health policy statutes ever enacted," respectively, while industry group BIO echoed that sentiment, calling on FDA to ensure that "any additional regulatory changes in furtherance of FDA’s stated goal to increase generic competition take account of both the already robust generic marketplace and the tremendous new authorities FDA recently has announced in this area."

In terms of REMS reform, Celgene suggests that FDA adopt a broad, flexible interpretation of "single, shared system" to streamline negotiations between innovators and generic applicants and to enable parties to tailor the systems and their implementation to the unique circumstances of each REMS.

BIO also questioned how the REMS system might be reformed, noting, "It is difficult to consider how this system could be ‘improved’ as discussed by the Agency in recent accounts without completely changing the statutory paradigm, including in ways that may potentially risk patient safety."

Administering the Hatch-Waxman Amendments: Ensuring a Balance Between Innovation and Access; Public Meeting

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Categories: Generic drugs, Compliance, Government affairs, Regulatory strategy, Regulatory intelligence, Submission and registration, News, US, FDA

Tags: REMS, Hatch-Waxman, generic drug competition

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