WASHINGTON, DC – Patients For Affordable Drugs President and founder David Mitchell will urge the Food and Drug Administration (FDA) to take action to boost generic competition and help fix out-of-control drug prices. At a public meeting today, Mitchell will share his story about how the out-of-pocket cost for Revlimid, a cancer drug he took for five years, increased by 500 percent during his treatment. Meanwhile, the maker of Revlimid refused to provide samples to companies seeking to develop a less expensive generic competitor.

“The importance of innovative, affordable drugs is not theoretical for me – it’s life and death,” said Mitchell. “But drugs don’t work if people can’t afford them. We hear from patients across the country about skipping doses, cutting pills in half, choosing between food and the drugs they need. I’m tired of people not being able to afford medicine because drug corporations block lower cost generic competition.”

Revlimid’s maker, Celgene Corporation, used its Risk Evaluation and Mitigation Strategy (REMS) as a pretext to refuse to provide samples. And it patented its REMS to avoid sharing information with generic companies.

Mitchell’s testimony (attached) encourages the FDA to:

• Request immediate congressional action. FDA should be explicit in support of solutions such as the bipartisan CREATES Act and FAST Generics Act, which aim to correct distortions of the law and require provision of samples.
• Forbid companies from declaring information about Risk Evaluation and Mitigation Strategies to be proprietary. After all, REMS are a public good. They are not intended to protect corporate monopolies.
• Collect and issue best practices for REMS so all manufacturers—brand and generic alike—can draw upon previous learnings and easily setup systems. If a drug corporation refuses to share REMS information with a generic manufacturer, the FDA should use its authority to waive the requirement for a single shared system.

FDA Commissioner Scott Gottlieb recently warned of the barriers to generic drug competition and said, “I want to take steps to address these concerns, to make sure that we are facilitating appropriate competition.”

The public meeting—titled The Hatch-Waxman Amendments: Ensuring a Balance Between Innovation and Access—will take place all day today at the FDA’s White Oak Campus in Silver Spring, MD.

Patients For Affordable Drugs is the only national patient organization focused exclusively on policies to lower prescription drug prices. It works to amplify the voices of Americans struggling under crushing drug prices to make policymakers and elected officials see the heavy toll of high priced drugs and take action. Patients for Affordable Drugs does not accept contributions from any organizations that profit from the development or distribution of prescription drugs.