Sen. Sanders: 'Immoral' that free drug now costs $375,000 per year

NEW YORK (FOX 5 NY) - U.S. Sen. Bernie Sanders, a Vermont independent and former candidate for the Democratic nomination for president, is slamming a pharmaceutical company for licensing a previously free drug and pricing it in the hundreds of thousands of dollars per year.

The drug treats Lambert-Eaton myasthenic syndrome, or LEMS, a rare autoimmune disorder that causes muscle weakness, according to the National Institutes of Health.

For many years, a version of the medication known as 3,4-DAP was distributed for free under the FDA's compassionate use program, according to Sanders.

In late 2018, the FDA approved Catalyst Pharmaceuticals, which licensed the rights to the drug, to exclusively market the drug in the United States under the brand name Firdapse until 2025. The approval came under the FDA's so-called orphan drug designation program.

Catalyst reportedly told shareholders that it would set Firdapse's annual price at $375,000, alarming many LEMS patients in the U.S., Sanders said. He sent a letter to Catalyst asking the company to explain how it justifies that price.

"By setting such a high price and forcing production and distribution of the older, inexpensive version to cease, you are threatening access that patients had to a cheap version of this product," Sanders wrote in the letter. "I am profoundly concerned that Catalyst's actions will cause patients to suffer and die."

Despite the drug's price tag on paper, individuals are not expected to pay that amount. Catalyst is marketing a program to help patients navigate the prescription and treatment process. The company's website also said that it will "make FIRDAPSE available to existing 3,4-DAP adult LEMS patients to begin transitioning to commercial product."

However, Sanders wants Catalyst to explain what it intends to charge patients, private insurance companies, and government payers for the drug.

"If Catalyst does not substantially lower the price of this medication, Congress must act to ensure it is affordable for every patient," Sanders said in a news release.

In response to FOX 5 NY's request for comment, Catalyst said it would address the letter from Sanders "in a timely manner."

"Catalyst's top priority is improving patient care in the LEMS community and potentially elsewhere within the neuromuscular community," the company said. "We will respond… provide information about Firdapse and the programs that we have in place to raise awareness of LEMS, facilitate accurate and timely diagnosis, and broaden affordable patient access to an FDA-approved treatment."