REMS Hurdles To Generic Entry: From Brand Access To Patent Claims
Can generic manufacturers use patented elements of a drug distribution plan? Will FDA accept an alternative REMS program? Will brand companies have to provide access to their products? As the number of brand products subject to REMS grows, so do the unanswered questions for generic firms.
You may also be interested in...
FDA approves a Risk Evaluation & Mitigation Strategy for Jazz Pharmaceutical’s Xyrem under protest; the agency says the single-pharmacy distribution plan for the narcolepsy treatment has the potential to block generic competitors from the market. FDA and Jazz had been working for seven years to agree to a REMS that confirms to the requirements under the FDA Amendments Act of 2007.
FTC files second amicus brief saying use of risk management programs to impede generic competition could violate antitrust laws; commission launched an investigation of Celgene four years ago.
Citing the use of Risk Evaluation and Mitigation Strategies to delay generic entry, Boston researchers urge Congress to revisit an “unintended consequence” created by the 2007 FDA Amendments Act.