Congress Urges FDA to Approve Generic Version of Crestor
July 11, 2016
By: Tim Casey, Cardiovascular Business
July 11, 2016
Senator Bernie Sanders and seven Democrats from the House of Representatives sent a letter on July 7 to FDA commissioner Robert M. Califf, MD, asking the agency to approve all generic versions of rosuvastatin calcium (Crestor).
AstraZeneca, which markets rosuvastatin calcium, is expected to lose patent protection on the blockbuster cholesterol lowering medication this month. However, on May 31, the company filed an appeal with the FDA asking for extended patent exclusivity for the medication.
Earlier in May, the FDA approved rosuvastatin calcium to treat children with homozygous familial hypercholesterolemia and granted AstraZeneca a seven-year exclusivity period to market the drug to those patients. As part of its appeal to the FDA, AstraZeneca said that the exclusivity period should apply to all patients that the drug is approved for, not just children with that rare disease.
The letter to Califf was signed by Sanders, an Independent from Vermont, and the following seven House members: Elijah Cummings (Maryland), Marcy Kaptur (Ohio), Lloyd Doggett (Texas), Jan Schakowsky (Illinois), John Sarbanes (Maryland ), Steve Cohen (Tennessee) and Peter Welch (Vermont).
“AstraZeneca has already enjoyed 12 years of market exclusivity for Crestor, with revenues over $16 billion from Crestor in the last three years alone,” the members wrote. “Pharmaceutical companies should not be permitted to block millions of patients from accessing lower cost generic equivalents at the last minute just so they can maximize their profits. This would be a disastrous anticompetitive, anti-consumer result.”