medscape.com
Backers of Generic Drugs Cry Foul Over Bioterror Bill
By Julie Rovner
WASHINGTON (Reuters Health) Oct 06 - Witnesses at a U.S. Senate hearing Wednesday accused the pharmaceutical industry of trying to increase its profits under the guise of helping protect the nation from a potential bioterrorist attack.
At issue before a joint hearing of the Senate Judiciary and Health, Education, Labor and Pensions Committees was a bill known as "BioShield II," a follow up to legislation signed by President Bush in July to give drug and vaccine makers incentives to produce "countermeasures" for potential bioterrorist weapons such as anthrax, Ebola or plague.
So far, said HELP Committee Chairman Judd Gregg, R-N.H., response to the $5.6 billion made available in the original BioShield bill has been "very anemic. Less than 100 companies have come forward" with products, he said.
A key reason, testified Christine Grant, Vice President for Public Policy for vaccine-maker Aventis Pasteur, is the original law's lack of liability protections. "For example, the absence of liability protection was a major obstacle in the recent procurement by NIH for development of the next-generation anthrax vaccine and continues to be a major hurdle for our company."
But several witnesses -- and a few Senators -- said the proposed bill overreaches with some of its incentives.
For example, said Sen. Charles Schumer, D-N.Y., a provision granting "wildcard exclusivity" could potentially allow a drugmaker to "conduct $20 million worth of research on one drug, then take a 2-year patent extension on one of its blockbusters." Schumer said the provision is "taking a noble purpose and sneaking in provisions which have nothing to do with protecting us from chemical or biological attack. It's Washington at its worst."
Carlos Angulo of the Coalition for a Competitive Pharmaceutical Market, which represents employers, insurers, and generic drugmakers, said the bill in its current form "would dramatically delay generic drugs from coming to market and cause a crippling increase in prescription drug costs for America's employers, health plans, and consumers." |
