Two MS Medications Appear on FDA’s Shame List

Ed Tobias avatar

by Ed Tobias |

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Risk vs. benefits


Two multiple sclerosis medications that are both popular and expensive are on a new list that U.S. regulators hope will increase price competition. The medications are Ampyra (dalfampridine), made by Acorda, and Tecfidera (dimethyl fumarate), by Biogen. They’re included on a list of more than 50 medications whose manufacturers, according to the Food and Drug Administration, are putting obstacles in front of companies that want to create cheaper, generic versions. FDA Commissioner Scott Gottlieb calls it “gaming the system.”

‘Gaming’ the system

Here’s what the FDA says is happening:

A company is trying to create a generic needs to obtain samples of the brand-name medication that it’s trying to copy. According to an FDA news release, a generic drug developer generally needs 1,500 to 5,000 samples of that medication to perform various tests that the FDA requires. But the agency has been getting complaints that some pharmaceutical companies are making it hard for the generic companies to buy those samples at a fair price on the open market.

The list reveals that the FDA has received inquiries from four companies that want to make a generic version of Ampyra, but are having trouble getting enough samples. The agency has received one inquiry from a company that wants to make generic Tecfidera and is having the same problem.

Overall, the FDA says it has received more than 150 inquiries from generic developers about “gaming,” but it’s hoping that shaming the manufacturers by publicizing this list will end their gaming.

This is taking action?

In its news release, the FDA says one of its “highest priorities is advancing policies that increase competition as a way to help make drugs more affordable and improve access.” Yet, the only action the FDA seems to be taking is creating this list and passing along the complaints to the Federal Trade Commission. The news release continues: “We hope that this increased transparency will help reduce unnecessary hurdles to generic drug development and approval.”

That’s it? Does Dr. Gottlieb really believe that a pharmaceutical manufacturer is going to roll over and make things easier for its generic competitors because it appears on a list posted to the FDA’s website? There’s legislation in Congress that would help generic medication producers obtain the samples they need, and the Congressional Budget Office estimates that legislation could save the federal government $3.8 billion over 10 years by lowering what Medicare, Medicaid, and other health programs would pay for prescription medications. Yet, there was no support for that, or even a mention of it, in Dr. Gottlieb’s recent statement.

As a TV commercial used to ask, “Where’s the beef?”

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Note: Multiple Sclerosis News Today is strictly a news and information website about the disease. It does not provide medical advice, diagnosis, or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website. The opinions expressed in this column are not those of Multiple Sclerosis News Today or its parent company, BioNews Services, and are intended to spark discussion about issues pertaining to multiple sclerosis.

Comments

Jill avatar

Jill

Biogen made 9.7 BILLION dollars profit the first year of Techfidera.
But it cost them "millions to develop it, and they took the risks" I believe is what they said. That was 4 years ago. I always felt there were a whole lot of zeros between million and billion. My annual salary would buy me 2-3 months of medication as it costs $6,000 for a months supply. They do offer a co-pay relief program. How sweet.

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Lauren avatar

Lauren

I get mine from FL (Skip's) as well. Used to get my Ampyra free from Acorda.

Medicare is billed $7500 for myTecfidera. I've been taking it for 5 years. Had to hustle to find grants to pay copays several years.

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Dorothy Kane avatar

Dorothy Kane

Aminopyridine-4, which is Ampyra, but not slow-release, has been made at compound pharmacies long before Ampyra was available. However, Acorda has been attempting to prevent pharmacies from doing this. I get mine from a very reputable compound pharmacy in Florida. And it's way less expensive than Ampyra.

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Ed Tobias avatar

Ed Tobias

Thanks for the info, Dorothy. I'm a little shy about using a compound pharmacy but it may be worth investigating.

Ed

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Dorothy Kane avatar

Dorothy Kane

Ed, the compound pharmacy I have used for years is Skip's in Deerfield Beach, Fla. I have at least two friends with MS who also have been using Skip's.
Dorothy

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Ed Tobias avatar

Ed Tobias

Thanks.

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Dianne Foltz avatar

Dianne Foltz

What do you pay Dorothy ?

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Cindy avatar

Cindy

I too get it compounded. $60 a month.

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Cynthia Fagen avatar

Cynthia Fagen

I just got Ampyra after I asked for it, 2 years after diagnosis. It is a big improvement. I suspect that they are not paying for nurses for speeches since it will be going generic and that is why it was not offered to me before, but I can't tell because nurses are still Sunshine Act exempt.

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CynF avatar

CynF

Toward the end of my brand name Ampyra, I mistakenly told them that I had some extra doses left from not taking the second one in the afternoon andthat I would use those until I got to the Dr to ask for the generic my insurance was demanding. This generated an official email wanting an explanation in writing, I wonder it had something to do with the trade secret thing?

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