Tuesday, July 21, 2009

Help Support Follow-On Biologics Legislation

Four of the six multiple sclerosis treatments are biologic drugs that can cost 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. The House Energy and Commerce Committee has jurisdiction to help provide the FDA a pathway for the review and approval of follow-on biologics.

Take Action!
  • Check to see if your Member of Congress sits on the House Energy and Commerce Committee. Click here to view the full committee list.
  • Call the Capitol switchboard at 1-800-828-0498 to be connected with your Member of Congress.
  • Mention the Promoting Innovation and Access to Life-Saving Medicine Act (H.R. 1427) as an ideal model for providing the FDA with a competitive, science based generic biologics pathway.
  • Ask them to leave the science of medicine in the hands of the FDA by providing a clear pathway free of regulatory hurdles.

For the estimated 400,000 Americans living with MS, this legislation brings the promise of safe, effective, affordable, and comparable biologic alternatives. As legislation moves forward, the Society will continue to advocate for a clear pathway that provides fair exclusivity to innovator companies.

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. Additionally, legislation to introduce a competitive pathway for follow-on biologics can help spur new innovation within the medical research field.

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