A broad coalition of groups pushing for generic biologic drugs sent a letter Thursday to House Energy and Commerce Chairman Henry Waxman (D-Calif.) urging him to drop the matter entirely if the House health care bill provides brand-name companies with a dozen or more years of market exclusivity.
This week, the Senate Health, Education, Labor and Pensions Committee approved a bill that included a pathway to approving generic, or follow-on, biologics with 12 years exclusivity.
AARP, the AFL-CIO, Consumers Union, Generic Pharmaceutical Association, Pharmaceutical Care Management Association and the Service Employees International Union, among others, signed the letter to Waxman.
Waxman has said he supports only a handful of years of market exclusivity for brands, but a competing bill sponsored by Rep. Anna Eshoo (D-Calif.) has been gaining far more momentum.
The groups letter states that with great regret, we respectively request that you move to drop any consideration of legislation to establish a biogeneric pathway UNLESS the exclusivity provisions in the Senate HELP Committee bill and the even more flawed Eshoo-Barton legislation can be notably improved in the health reform process.
The letter added that, In all frankness, we cannot be supportive of any generic biologics legislation that would be an empty promise to the Americans we represent and serve.
Biologics are expensive and complex therapies, typically given by injection, that are often used to treat serious illnesses such as cancer, multiple sclerosis and rheumatoid arthritis.
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