FDA Rejects Petition For Guidance On Shared REMS Programs

File this under ‘nice try, but…’ Four months ago, a Nestle unit called Prometheus Laboratories asked the FDA for assistance on a nagging and potentially important question - what should a brand-name drugmaker do when an aspiring generic rival wants to negotiate the terms of a shared risk management program and the talks go nowhere? Unless there is an undue burden, a 2007 law stipulates that the drugmakers should work together on coordinating a shared REMS program, but there is actually no guidance for navigating what can be a very complicated situation. And so, as we reported last June, Prometheus Laboratories filed a citizen’s petition with the FDA to request a formal guidance on the topic in hopes of gaining some clarity. The move was sparked by apparently fruitless negotiations with Roxane Laboratories, a unit of Boehringer Ingelheim that wants to sell a generic version of Lotronex, a treatment for irritable bowel syndrome that Prometheus has sold with a REMS program since 2010. As we wrote previously, the petition raised several unanswered questions about the extent to which rival drugmakers must set aside competitive differences – despite the possibility of opposing legal positions concerning patent rights and product liability - in the name of establishing a uniform method for ensuring patient safety.  Prometheus also suggested there are anti-trust concerns in play (here is the Prometheus petition). The FDA, however, has rejected the petition. Why? For one th...
Source: Pharmalot - Category: Pharma Commentators Authors: Source Type: blogs