In an unusual move, Sen. Bernie Sanders (I-Vt.) asked federal regulators to allow a small drug maker and compound pharmacies to resume supplies of a rare-disease treatment. And he cited patient complaints over pricing by Catalayst Pharmaceuticals (CPRX), which recently won regulatory approval for its own version and seven years of exclusive marketing that legally permits it to preclude sales of older, competitive medicines.
The move is the latest effort by the lawmaker to confront Catalyst, which now sells a drug to treat Lambert-Eaton myasthenic syndrome, or LEMS. Until December, patients could obtain an unapproved version for free from Jacobus Pharmaceuticals, a small, family-run company, thanks to a compassionate use program overseen by the Food and Drug Administration.
However, Catalyst has triggered a firestorm of concern because it priced its drug, called Firdapse, at $375,000. The company has attempted to mitigate criticism by pointing to a patient assistance program that should lower costs to about $10 a month, but Sanders has maintained that taxpayer-funded health programs — notably, Medicare and Medicaid — may still bear the brunt.