- A judge is allowing Mylan's lawsuit against Celegene to go forward. The suit, which alleges illegal anti-competitive use of Risk Evaluation and Mitigation Strategy (REMS), involves two drugs: Revlimid (lenalidomide) and Thalomid (thalidomide).
- REMS is a program set up by the FDA to ensure safe use of a potentially dangerous drug. Elements of the program include a communication plan, medication guides and elements to assure safe use of the drug (ETASU). Many brand-name drug manufacturers have used REMS as a way to keep out generic competitors by imposing "safety-related" conditions on companies seeking to copycat their drugs.
- Celgene has been using REMS to block generic copy-catting of Revlimid and Thalomid, according to a statement from Mylan.
The controversy over brand manufacturers using REMS to prevent generic competition has been simmering for a while, prompting Ralph Neas, president and CEO of the Generic Pharmaceutical Association (GPhA) to issue a statement against this practice. As Neas explained to BioPharma Dive in December, "Subversion of REMS translated into $5.4 billion in annual losses due to generic drugs not allowed to come to market."
Although the FTC has not taken action, protest against misuse of REMS is starting to play out in the courts. Mylan filed the suit in April 2014, after attempting unsuccessfully to purchase samples of Thalomid in 2003 and Revlimid in 2009. Celgene cited concerns about distribution and continued to withhold until finally Mylan decided to take it to the courts. Resolution of this case could be an important part of stopping this practice.