Buprenorphine Waiver Sheds Little Light On FDA Decision-Making Process
But the agency appeared willing to consider a waiver because the innovator and generic sponsors could not reach agreement on a shared REMS.
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Brand name companies’ use of restricted distribution programs to block the development of generic drugs has been an unintended consequence of the FDA Amendments Act of 2007. The generics industry has long complained that the use of FDA-required risk management plans prevents access to affordable medicines. While that battle has ranged in the courts, FDA has remained quiet on the subject. Until now.
Agency will wait until it has more experience with shared REMS before deciding whether to issue regulations or guidance on their implementation, but for now it hopes sponsors can work out problems on their own.
Hurdles to developing multi-sponsor programs include disagreements on design, decision-making and cost-sharing. PDUFA V initiatives on standardizing and integrating REMS could give FDA a means for providing more formal guidance or rulemaking on developing shared systems, as some in industry have requested.