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Biodefense Promotion Bill Moves Toward Senate Floor By David Ruppe and David Francis WASHINGTON — Democrats this week again were unable to amend a Senate bill intended to encourage corporate and academic investment in biological defense vaccines and drugs (see GSN, Oct. 19). The Senate Health, Education, Labor and Pensions Committee last week approved the Biodefense and Pandemic Vaccine and Drug Development Act of 2005. Despite continued negotiations, panel members on Monday reported the legislation out of committee without significant changes to address Democratic objections. The bill is now set to go to the Senate floor. Senator Richard Burr (R-N.C.), who chairs the Bioterrorism and Public Health Preparedness Subcommittee that developed the bill, intends to continue negotiating with Democrats as the bill heads for a yet-unscheduled floor vote. “Some Democrat members had some concerns that he wanted to address and that’s what’s currently being done … with the hope of it being a bipartisan bill,” said Burr spokesman Doug Heye. The bill calls for creation of the “Biomedical Advanced Research and Development Agency” — a new Health and Human Services office to help organize government biodefense investment. Democrats last week signaled support for creating such an agency. However, they have criticized a provision in the bill that would exempt it from Freedom of Information Act, Federal Advisory Committee Act, and congressional cost accountability requirements. “Exempting BARDA from FOIA is just ridiculous. Even intelligence agencies are subject to FOIA requests,” said Nick Schwellenbach, an investigator for the Project on Government Oversight in Washington, D.C. “Suspicions on the part of nations about the intent of each other’s biodefense activities can lead to an arms race in biological weapons,” wrote Alan Pearson, director of the Center for Arms Control and Nonproliferation’s Program on Biological and Chemical Weapons, and Lynn Klotz, a senior fellow at the center, in a joint statement. Democrats also oppose a component of the bill stating that the Health and Human Services secretary must approve any liability lawsuits against drug and vaccine manufacturers for treatments used in a declared biological public health emergency. There should be at least an alternative arrangement for public compensation through the federal government, according to critics of the provision. The bill also would allow Health and Human Services to sign exclusive sales contracts with manufacturers for a particular product. It would forbid government purchases of generic versions of such new drugs or vaccines as well as public sales of the products for use as countermeasures. Democrats have said that provision would drive up the price of treatments that would be vital in a national emergency. Democrats also have criticized the bill for not addressing short-term U.S. needs to battle a potential avian flu pandemic, while instead focusing on measures to address longer-term research and development of drugs and vaccines. After approving the bill’s text last week, the committee’s Republican leaders vowed to work with Democrats to try to address their concerns before reporting it out. However, little of the text appeared to have changed by Monday, perhaps with one exception. Potentially Reduced AuthorityA change in the bill’s language appears to reduce the proposed new agency’s authority for organizing federal biological defense research and development efforts. It would change the proposed role of the Biomedical Advanced Research and Development Agency from “directing and coordinating” to “facilitating.” “‘Facilitating’ is significantly weaker,” Pearson said. Otherwise, he said, “The bill does not change anything one way or the other now.”
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