FDA needs authority to approve generic biologics

Mar 8 2007

AARP called on Congress today to give the Food and Drug Administration (FDA) the authority to approve safe, cost-effective generic versions of often expensive biologic drug therapies.

Safe, generic alternatives to brand name drugs have existed for more than 20 years, but there is currently no pathway for FDA approval of generic versions of biologic therapies. Millions of Americans depend on biologic therapies, however many are prohibitively expensive. For example, Epogen, a drug used to treat anemia, can cost as much as $10,000 per year and Cerezyne, used to treat Gaucher disease, can cost as much as $200,000 per year.

"A therapy is only helpful to the patient who has access to it. Biologics hold great promise for treating serious diseases such as cancer, multiple sclerosis, anemia and rheumatoid arthritis, but when some treatments cost thousands of dollars per dose, many patients cannot afford to fill their prescriptions," said AARP President Erik Olsen.

AARP endorsed the bipartisan "Access to Life-Saving Medicine Act of 2007" (S. 623/H.R. 1038). Under current law, after the patent of a brand-name prescription drug expires, a generic manufacturer can market a generic version of the drug. No such provision is in place for biologics. S. 623 and H.R. 1038 would direct the FDA to establish a process for bringing these treatments to market. It would ensure that Americans have improved access to generic biological drugs.

"Science has progressed to the point where it is possible to create generic biologics and to do so safely. All FDA lacks is the authority to approve these therapies. AARP urges that for the sake of patients, Congress can come together, pass this bill and give the FDA the authority to provide a better life to millions of Americans," Olsen added.