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Donkees

(31,413 posts)
Thu Feb 28, 2019, 12:15 PM Feb 2019

Senator Sanders urges FDA to allow older versions of $375K drug

HEALTH NEWS FEBRUARY 28, 2019
Yasmeen Abutaleb, Deena Beasley

Excerpt:

(Reuters) - 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.

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 spokeswoman Jennifer Rodriguez, in an emailed statement, said the FDA has received the letter and will respond directly to the senator. HHS also said it has received the letter and will respond.

“Catalyst may be the most recent company to exploit their monopoly after receiving FDA approval for an inexpensive old drug, but they were certainly not the first,” Sanders said in the letter.

He noted the prices of very old and inexpensive drugs like colchicine, vasopressin, neostigmine, and others have been raised substantially by drugmakers following FDA approval, causing needless suffering and adding to the cost of health care.

https://www.reuters.com/article/us-usa-healthcare-catalyst/senator-sanders-urges-fda-to-allow-older-versions-of-375k-drug-idUSKCN1QH1LK

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zaj

(3,433 posts)
1. What does "older drug" mean?
Thu Feb 28, 2019, 12:21 PM
Feb 2019

Are these remaining old inventory of the same drug?
If it's old formulations of a drug outside of patent, can't anyone make and sell those drugs today?
What role is the FDA taking to block these old drugs? What justification would they make to do that?
Why is Sanders (or anyone) only now fighting this battle?

Something doesn't add up here.

Donkees

(31,413 posts)
3. Some background: This Life-Saving Drug Just Went From $0 to $375,000
Thu Feb 28, 2019, 12:51 PM
Feb 2019


Published on Feb 4, 2019
For two decades, LEMS patients have received a drug for free from Jacobus Pharmaceutical under the Food and Drug Administration’s compassionate use program. Recently, Catalyst Parmaceuticals bought the drug and announced to investors it would set the list price at $375,000 per year. Rebecca, one of the many patients who does not know how she will afford it, talked to Sen. Bernie Sanders about what's going on.


Sanders Asks What Impact $375,000 Drug Will Have on Taxpayers

Wednesday, February 6, 2019

WASHINGTON, Feb. 6 – Sen. Bernie Sanders (I-Vt.) demanded answers Wednesday from the Department of Health and Human Services and the U.S. Centers for Medicare and Medicaid Services about the cost to taxpayers of Catalyst Pharmaceuticals' drug Firdapse. Catalyst recently announced an annual list price of $375,000 for the medication, which patients previously received for free from Jacobus Pharmaceutical.

"I am writing to request information regarding the price Catalyst Pharmaceuticals will charge Medicare and Medicaid for Firdapse...and the impact this price will have on patients with LEMS and taxpayers," Sanders wrote to Alex Azar, the secretary of Health and Human Services, and Seema Verma, the administrator of the Centers for Medicare & Medicaid Services. "It is abundantly clear that Catalyst expects taxpayers, primarily through Medicare and Medicaid, to foot the bill for its price gouging,"

According to Securities and Exchange Commission filings for 2018, Catalyst conducted market research and determined that "most LEMS patients have insurance coverage," including approximately "40 percent Medicare, Medicaid, [and] 10 percent dually eligible for both Medicare and Medicaid."

Earlier this week in response to fear from patients that they would no longer be able to afford the life-saving medication that has been available for decades, Sanders demanded that Catalyst explain its decision to set the price of Firdapse, a drug used to treat a rare neuromuscular disease called Lambert-Eaton myasthenic syndrome (LEMS), at $375,000 per year.

Catalyst publicly said that it will reply to Sanders’ request, but the company has not yet provided any information.

Last week, Sanders spoke via Skype with a patient impacted by the price increase, Rebecca Hovde of Wellman, Iowa, who told him about the incredible anxiety people with LEMS are living with as a result of Catalyst’s decision to increase the price. “I have friends saying that it’s too much. They know they can’t afford it. And they’re just going to go to bed when their 3,4 DAP runs out,” Hovde told Sanders. (Watch the full conversation here.)

Read Sanders' letter to HHS and CMS here.
https://www.sanders.senate.gov/newsroom/press-releases/sanders-asks-what-impact-375000-drug-will-have-on-taxpayers

Donkees

(31,413 posts)
5. Catalyst bought the U.S. rights to the drug in 2012 and got approval to sell it in the US in Nov.
Thu Feb 28, 2019, 01:10 PM
Feb 2019
For years, patients were able to get Firdapse for free from Jacobus Pharmaceuticals, a small New Jersey-based drug company that offered the drug through a U.S. Food and Drug Administration (FDA) program called Compassionate Use.

The program allows patients with rare diseases and conditions access to drugs not yet approved outside of a clinical trial, when there is no viable alternative.

Catalyst bought the U.S. rights to the drug in 2012 and got approval to sell it in the US in November last year.

"Now, for the first time, LEMS patients have confidence their therapy is FDA approved and is safe and effective," Catalyst's Chief Executive Officer Patrick McEnany said in a letter (https://bit.ly/2NkmIRU).

The company said that Firdapse's price was similar to other medicines that provide a significant clinical benefit in treating ultra-rare diseases, adding it believed the drug would be widely reimbursed by insurers for the small population it treats.

https://www.streetinsider.com/General+News/Catalyst+Pharmaceuticals+defends+%24375%2C000+drug+price+after+Bernie+Sanders+rebuke/15162558.html

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