New Bioterrorism Bill Would Bust Health Care Budgets, GPhA

Main Category: Bio-terrorism / Terrorism
Article Date: 30 Apr 2005 - 9:00 PDT


The US Generic Pharmaceutical Association (GPhA) today said that while new Senate legislation aimed at improving America's security includes promising incentives, several provisions in the bill would dramatically increase health care costs for consumers and the federal government and deliver windfall profits to brand pharmaceutical companies.

"We support efforts to encourage the production of countermeasures, but not measures that would threaten the economic viability of our health care system," said GPhA President and CEO Kathleen Jaeger. "Outrageous measures to extend brand monopolies like 'wild cards' and overly generous patent extensions will only delay consumers' access to affordable medicines. Such measures have been soundly rejected by Congress in the past as catering to special interests at the public's expense. These measures should still be rejected today."

Senators Joseph Lieberman, Orrin Hatch and Sam Brownback introduced the "Project BioShield II Act of 2005," legislation intended to strengthen America's preparedness to bioterrorism through measures that accelerate the research, development and manufacture of novel countermeasure agents. The bill contains promising incentives, such as needed product liability protections, expanded tax incentives, and fast track Food and Drug Administration review of drug applications, which GPhA supports. However, it also includes provisions that would provide substantial and unnecessary windfalls to the brand pharmaceutical industry and impose a tremendous and needless burden on the nation's health care system.

"Brand pharma is playing off of Americans' fears to extend their product monopolies and keep affordable medicines off the market," Jaeger said. "In its current form, this legislation is little more than a giveaway to the brand pharmaceutical industry."

Among other measures, GPhA remains opposed to

-- The overly broad definition of a countermeasure, which could be extended to already approved products. Because the legislation fails to limit the term to novel medicines, which are clinically superior or fill a security priority void, patent extensions could be applied to a wide range of already approved drugs.

-- Extending product monopolies up to 13 years through inappropriate market exclusivity provisions.

-- Unlimited and uncapped patent extensions on any countermeasure product. Under this bill, multiple patents claiming the brand product could be extended.

-- "Wild card" provisions that could be applied to any product in a company's portfolio, thus providing a windfall to brand pharmaceutical companies for products wholly unrelated to bioterrorism.

"GPhA is looking forward to working with Congress to develop sound legislation that supports the overall goal of securing America," said Jaeger. "No industry is more committed than the generic drug industry to protecting public safety, ensuring access to affordable, high-quality pharmaceuticals, and rewarding true innovation."

GPhA represents the manufacturers and distributors of finished generic pharmaceuticals, manufacturers and distributors of bulk active pharmaceutical chemicals, and suppliers of other goods and services to the generic drug industry. Generics represent 53% of the total prescriptions dispensed in the United States, but less than 12% of all dollars spent on prescription drugs.

The Generic Pharmaceutical Association is committed to improving lives for less. For further information, please contact GPhA at 703-647- 2480, or visit our web site at http://www.gphaonline.org.

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