WASHINGTON, March 8 /PRNewswire-USNewswire/ -- 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
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
"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.