U.S. Senator Bernie Sanders this week urged regulators to allow pharmacies and m...
- U.S. Senator Bernie Sanders this week urged regulators to allow pharmacies and manufacturers to resume distributing unbranded, lower-cost versions of a drug used to treat a rare neuromuscular disorder, according to a letter provided by his office to Reuters.
Florida-based Catalyst received Food and Drug Administration approval for Firdapse in November, along with exclusive rights to market the medication for several years. The drugmaker, in response to a recent query from Senator Sanders, said its prices are in line with similar products in the industry.
In the Feb. 26 letter, Senator Sanders, citing the Catalyst drug’s “shocking price,” called on FDA Commissioner Scott Gottlieb to announce that the agency will not take enforcement action against pharmacies and manufacturers that were previously providing the drug to patients. Sanders also gave the letter to Health and Human Services Secretary Alex Azar in a private meeting on Tuesday.
FDA approval of Makena came years after pharmacies had already been compounding such a drug at far lower prices than Makena, using an active ingredient, hydroxyprogesterone, available without formal FDA approval.
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