RARE Daily

Patient Group Calls on BIO to Disavow “Price Gouging” by LEMS Drugmaker

March 7, 2019

The controversy over drug prices has gone up another notch as an advocacy group, Patients for Affordable Drugs sent a letter to James Greenwood, president and CEO of the Biotechnology Innovation Organization, telling him that the trade group has “an opportunity to disavow price gouging and exploitation of unrestrained market power” by Catalyst Pharmaceuticals, one of its members.

Photo: James Greenwood, president and CEO of the Biotechnology Innovation Organization

The letter comes just weeks after Senator Bernie Sanders, D-Vermont, sent a letter to Catalyst calling the $375,000 per year price it had set for Firdapse egregious and “an immoral exploitation of patients who need this medication.”

Catalyst won marketing approval for Firdapse in late 2018 for the treatment of Lambert-Eaton Myasthenic Syndrome (LEMS), a rare neuromuscular autoimmune disease in which the immune system attacks the areas where the nerves and muscles connect, affecting the way they communicate and making it difficult to move the muscles normally.

For years, LEMS patients had been able to get the same drug, known as 3,4-DAP, for free from Jacobus Pharmaceutical under a U.S. Food and Drug Administration compassionate use program. But Catalyst now holds exclusive marketing rights in the United States for seven years under the FDA’s orphan drug designation.

Catalyst responded to Sanders by defending the price and insisting that most patients’ out-of-pocket expense would be $10 or less. It further noted that only about 200 patients were receiving the experimental drug out of about 3,000 LEMS patients in the U.S. Now all LEMS patients have access to treatment. 

Patients for Affordable Drugs argued that just because individual patients will not be paying much, private insurers and government programs will end up footing most of the bill, resulting in higher premiums and higher taxes for all Americans.

“There is no possible moral justification for this move by your member, Catalyst,” the organization wrote. “This is abuse of our laws and regulatory framework to exploit patients, consumers, and taxpayers.”

The patient group also pointed out that Catalyst was receiving millions of dollars of taxpayer-financed benefits that come with Orphan Drug approval including tax credits and reduced user fees.

On February 22, 2019, Patients for Affordable Drugs launched a petition asking Greenwood to denounce Catalyst’s actions and rescind their membership in BIO. The petition was signed by 1,760 people, all of whom were listed in the letter.

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