Two MS Medications Appear on FDA’s Shame List

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.