- In a statement, FDA Commissioner Scott Gottlieb, M.D. announces draft guidance aimed at curtailing behavior by branded drug makers to delay competition from generics.
- The proposed policy will allow generic firms to apply for a waiver of the Single Shared System REMS Requirement permitting them to use a comparable REMS (Risk Evaluation and Mitigation Strategy) program instead of the one used by the branded drug maker.
- The rationale for a single REMS program for both branded and generic medications is it makes it easier for medical professionals and distributors to follow safety procedures. Heretofore, generic firms have had to negotiate with branded firms to enter into their REMS program, a predictably long process considering branded companies' lack of enthusiasm for generic competition.
- The comment period is not specified.
- Selected tickers: IHE, XPH, PPH, GNRX, XBI, IBB, OTCQX:RHHBY, ABBV, AGN, AZN, BMY, GSK, JNJ, LLY, MRK, NVO, NVS, PFE, SHPG, VRX, TEVA, MNK, PRGO, MYL, LCI, RDY, AKRX
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