I
n 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.