In what may be a first, a patient has filed a lawsuit accusing a drug maker of hiding behind a mandated safety program to thwart generic competition. The company, in this case, is Celgene.
The lawsuit, which was filed by a cancer patient and consumer advocate named David Mitchell, accused the biotech of exploiting a Food and Drug Administration program that is designed to boost safety. Typically such a program, known as a Risk Evaluation and Mitigation Strategy, requires drug makers to develop a plan to educate physicians and monitor distribution.
Unfortunately Mr. Mitchell, a 66 year old patient with multiple myeloma has a much larger problem than restraint of competition. Even if Mylan were to produce a valid BE study tomorrow, the court has ruled that the Revlimid patent is valid until 2022, and unfortunately the best case scenario for MM life expectancy is 62 months.
Comments are closed.