AARP Urges Congress to Act on Generic Biologics

Generics to treat cancer, MS, and other debilitating diseases could save patients billions of dollars

Source: AARP Press Center |  | March 26, 2007

In testimony before the U.S. House Committee on Oversight and Government Reform, AARP today called on Congress to pass legislation that will allow the Food and Drug Administration (FDA) to approve safe, cost-effective generic versions of often expensive biologic drug therapies. AARP has endorsed the bipartisan bill, “The Access to Life-Saving Medicine Act of 2007” (S. 623/H.R. 1038).

Safe, generic alternatives to traditional 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.

“Biologics hold great promise for treating serious diseases such as cancer, multiple sclerosis, anemia and rheumatoid arthritis. But these treatments are only helpful to patients who can access them. Most Americans cannot afford to pay the thousands of dollars a year that a brand-name biologic drug can cost. Safe, cost-effective generic biologics are a common sense alternative,” said AARP Board Member Nelda Barnett who testified before the committee today.

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. The FDA simply lacks the authority to approve these therapies. AARP urges Congress to come together, pass this bill and give the FDA the authority to help provide a better life to millions of Americans,” Barnett added.