Brand, Generic Disputes Over Access Move Beyond REMS Restrictions
Generic companies say innovators are using voluntary restricted distribution programs to prevent them from obtaining reference drugs for bioequivalence testing; a July hearing is set in a dispute involving Actelion’s Gaucher disease drug Zavesca, which is not subject to a Risk Evaluation and Mitigation Strategy.
You may also be interested in...
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.
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.