Four of the six multiple sclerosis treatments are biologic drugs that cost between $16,500 to more than $30,000 per year. Biologic drugs are produced from living cell cultures rather than synthesized chemically as in traditional drugs. No generic (or follow-on versions) of biological therapies are available because the Food and Drug Administration (FDA) does not yet have the authority to review those drugs.
Congress must pass legislation in order to create a regulatory pathway for the FDA to approve safe and effective follow-on versions of biologic drugs. As Congress prepares health care reform legislation, now is the time to make a difference.
- Click here to send your Member of Congress an e-mail to encourage them to include legislation for follow-on biologics in the broader health care reform package.
- Mention the Promoting Innovation and Access to Life-Saving Medicine Act (H.R. 1427 and S. 726) as an ideal model for this legislation.
The FDA does not have the authority to review applications for generic or follow-on alternatives to biologic drugs like other counties do. Because no generic versions of these drugs exist, the cost of biologic treatments can keep them out of reach for those who need them. More affordable follow-on versions could provide safe alternative treatment options and help alleviate the cost burden on families living with chronic diseases.
Legislation to introduce a competitive pathway for follow-on biologics can help spur new innovation within the medical research field. With affordability being a key component in the health care reform debate, it is necessary to contact Members of relevant committees and encourage them to include follow-on biologics in the comprehensive health care reform package.