Few attend BioShield II hearing

WASHINGTON, DC—At a sparsely attended Senate hearing Wednesday (October 6) on potential improvements to the BioShield legislation signed into law in July, several pharmaceutical manufacturers pleaded for stronger liability protection, while an infectious disease expert urged a broadening of the provisions to encourage antibiotic development. Only a handful of senators attended the hearing off and on, as Congress is busily trying to finish its business before the election.Sen. Patrick Leahy (D-Vt.), who appeared for a short period and whose office received an anthrax-laced letter in 2001, said he was outraged that what he called "important" proposals to improve bioterrorism defenses were scheduled for a hearing when most senators are unavailable. The joint Health, Education, Labor and Pensions, and Judiciary committee hearing was held ostensibly to examine flaws in BioShield and to entertain suggestions for fixing the law.Bioshield allows the government to spend $5.6 billion over 10 years to develop and purchase "huge amounts" of vaccines or drugs to treat a variety of potential bioterrorism agents and also gives the National Institutes of Health (NIH) and the Food and Drug Administration (FDA) new leeway on procedures for grant and drug approval, respectively. Although it had bipartisan support in Congress, scientists had criticized BioShield, saying that funds might be squandered or wasted since there is no straightforward way to create vaccines or antimicrobials and that because bioweapons are likely to employ modified strains of biological agents, vaccines and treatments developed in advance would not be effective.That law's original author, Sen. Joseph Lieberman (D-Conn.), was due to testify yesterday but was busy with an intelligence reform bill and did not appear. In March 2003, Lieberman and Sen. Orrin Hatch (R-Utah) introduced a potential successor to BioShield—the Biological, Chemical, and Radiological Weapons Countermeasures Research Act (S 666). That bill has not received a committee hearing, but is the basis for BioShield II, said Hatch, who stopped in to make an opening statement. The bill will be reintroduced next session, he said. "We already have ample reason to believe that the July law—while an important first step—is not sufficient and that we need to enact a more comprehensive legislative strategy," Hatch said. He emphasized that neither he nor Lieberman believed the government should be in the business of providing seed or development capital to potential diagnostic, vaccine, or therapeutics manufacturers. "Direct government funding for this research is not the most effective strategy," he said.In submitted testimony, Lieberman said that BioShield II aims "to shift the risk of countermeasure research and development to the industry." But, he noted, the legislation should also assure manufacturers that "the government will be a reliable partner." Lieberman criticized the Health and Human Services Department's initial forays into procurement, saying his staff heard the agency would not guarantee a government contract unless a therapy had already received investigational new drug status from the FDA and that companies should seek initial funding from the NIH.Venture capitalists, not the NIH, should be providing that money, said Lieberman. As a sweetener for manufacturers, BioShield II would offer tax incentives and patent extensions, limited exemptions from antitrust laws, and a slight expansion of liability protection.Christine Grant, vice president of public policy and government relations for Aventis, said the company strongly backed new protections. The lack of liability protection has held up development and procurement of a next-generation anthrax vaccine, she said, adding, "We just can't get commercial liability protection anywhere near approaching reasonable prices."The Generic Pharmaceutical Association and the Coalition for a Competitive Pharmaceutical Market (a group of large corporations and other drug purchasers and generic manufacturers) said that BioShield II's patent provisions would allow brand-name manufacturers to secure extensions on products not related to biodefense, costing consumer billions. Sen. Charles Schumer (D-NY) echoed their testimony, saying he would fight the bill if it contained the patent extensions. "This is Washington at its worst," Schumer said, calling it a gift to the pharmaceutical industry.However, John Bartlett, chair of the Infectious Diseases Society of America's (ISDA's) Task Force on Antimicrobial Availability, argued that perhaps more drug categories should get special exemptions under BioShield II. Bartlett, chief of infectious diseases at Johns Hopkins University School of Medicine, said IDSA is concerned about antibiotic resistance and the lack of therapies in the pipeline. Government help is needed, he said, adding that there's little incentive for manufacturers to develop antibiotics. "The other markets in medicine are much more profitable than the antibiotics market," he said.

Few attend BioShield II hearing

Senators skip meeting on potential ways to improve $5.6 billion US biodefense program

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