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Regulatory Focus™ > News Articles > 8 > Updated: FDA Draft Guidance for Waivers of REMS Requirement Draws Mixed Reactions

Updated: FDA Draft Guidance for Waivers of REMS Requirement Draws Mixed Reactions

Posted 19 September 2018 | By Ana Mulero 

Updated: FDA Draft Guidance for Waivers of REMS Requirement Draws Mixed Reactions

A recent US Food and Drug Administration (FDA) draft guidance on a requirement under the Risk Evaluation and Mitigation Strategy (REMS) program for pharmaceutical sponsors was met with mixed reactions from a Rutgers law professor and Novartis in new comments.
The draft guidance that set the stage for how sponsors' requests for waivers of the single, shared system (SSS) requirement would be evaluated by FDA was issued earlier this year, along with a separate guidance newly drafted for the development of a REMS for multiple prescription drugs.
Stakeholders had until 30 August to comment on both draft guidances, which seek to mitigate potential abuse of REMS requirements and support greater access to generics drugs in the US. The extended public comment period on the second draft guidance closed on 13 September, with similar mixed reactions to the first. 

Still, the law professor expressed support for the proposed draft policies, whereas Novartis called for changes to factors FDA intends to consider for waivers of the SSS requirement. 
Exploitation of REMS requirements undermines the Hatch-Waxman Act of 1984, Rutgers law professor Michael Carrier said. FDA, however, has “taken a significant interest in the REMS issue, which brand drug firms have used to delay generic entry,” Carrier told Focus.
The draft’s proposed changes include considering waivers at any time, including in the middle of a review on a pending application, and applicants’ attempts to negotiate or obtain licenses. This new guidance is a step in the right direction for tackling the REMS issue “since brand firms can slow-walk the shared REMS process,” Carrier added. “Quicker waivers therefore are appropriate.”
Yet Novartis raised two specific concerns on the proposed changes, calling on FDA to define how a SSS negotiation would be considered “unsuccessful.” This is because “there may be instances where negotiations are not moving despite best efforts from one party,” said Gretchen Trout, head of North America policy at Novartis Pharmaceuticals, in the submitted comment.
The pharmaceutical company is also seeking clarification on the term “different, comparable aspect” of the elements to assure safe use. It is currently “unclear and does not provide drug sponsors guidance on how to move forward,” Trout added.

Development of a Shared System REMS 

Meanwhile, the draft guidance on developing a shared REMS system for multiple products raised red flags among some of those who submitted comments. These include generic drug company Perrgio, the Association for Accessible Medicines (AAM) and PhRMA.

Perrigo and PhRMA called for policies on earlier interactions, such as via a pre-submission meeting for an abbreviated new drug application (ANDA). They seperately requested further clarificaitons on whether the draft is intended to supersede ANDA submissions final guidance and on FDA’s role in SSS negotiations.

AAM suggests FDA "take a more proactive role in the negotiation process under its existing statutory and regulatory authority," said David Gaugh, senior VP for sciences and regulatory affairs. "FDA should initiate the process upon submission of an ANDA subject to the SSRS [single, shared risk evaluation and mitigation strategy system] requirements instead of waiting until the ANDA has been received for review. This will allow more time for the parties to negotiate the complex business terms of a SSRS."

The association also argued for FDA to retain full discrection to grant waivers on a case-by-case basis. 
Waivers of the Single, Shared System Risk Evaluation and Mitigation Strategy Requirement

Updated on 9/19/18 to include AAM, PhRMA and Perrigo's comments.

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