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Critics See Higher Drug Prices in Bioshield II

By Emily Heil
CongressDaily

WASHINGTON - A coalition including employers and generic drug makers on Friday launched a pre-emptive strike against the "Bioshield II" bill that Senator Richard Burr (R-N.C.) is slated to introduce this week, saying the patent extensions it would grant to prescription drugs could suppress generics and raise costs for employers, consumers and the government (see GSN, June 10).


The bill, which is in draft form, would allow brand drug makers to classify a broad range of drugs as "countermeasures" to potential bioterrorism attacks, a category that would allow them to extend patents for drugs that have little to do with biodefense, according to members of the Coalition for a Competitive Pharmaceutical Market, which includes generic drug makers, employers, manufacturers and pharmacy benefit managers. That in turn would raise costs for employers who provide drug benefits to employees, government programs such as Medicare, and to consumers who would be denied access to generic versions of pricey brand drugs, they said.

"Hopefully, senators concerned about the federal budget deficit and about the ability of the federal government to provide drug benefits will appreciate the direct and significant impact this will have on drug costs," said Kathleen Jaeger, president of the Generic Pharmaceutical Association.

The legislation is still being negotiated, a Burr spokesman said.

"It's premature to criticize legislation that hasn't been introduced," he said. "But Senator Burr has made clear that whatever bill is introduced, it will provide for more and better countermeasures to market faster - that's his No. 1 priority."

The Bioshield bill might be marked up in the Senate Health, Education, Labor and Pensions Committee as soon as this week. Project Bioshield is the administration's effort to develop and secure commercial countermeasures to bioterrorism threats.

Under the program, the Health and Human Services Department is to identify threats and encourage industry to produce medical countermeasures. The theory is companies will develop vaccines and other products for which the government would be the only likely purchaser, as long as they know the demand exists. Without incentives, the government might lack a sufficient supply of treatments or vaccines for bioterrorism threats such as anthrax, botulism and Ebola.

In this second installment of Bioshield legislation, Burr is planning to expand the program and ease liability for the makers of bioterror countermeasures. In the latest draft of the bill, Jaeger said, the committee dropped the "wild card" exclusivity that previous drafts of the bill had included, which she called "the most egregious" patent extension. Under the wild-card provision, companies that develop countermeasures could receive additional patent life for any product they chose.

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