Incentives To Research Vaccines Under Project BioShield a Priority for Congress in 2005, Lawmakers Say
Legislation that would create more incentives for pharmaceutical companies to research and develop vaccines as an extension of the Project BioShield initiative will be a priority of the 109th Congress, members of the Senate Health, Education, Labor and Pensions and Judiciary committees said Wednesday at a joint hearing, CQ Today reports (Schuler, CQ Today, 10/6). BioShield (PL 108-276), enacted in July, authorizes $5.6 billion over the next 10 years to encourage pharmaceutical and biotechnology companies to work with NIH to develop antidotes, vaccines and other products to treat and protect against anthrax, smallpox, botulism, plague, Ebola virus and radiation from "dirty bombs."
Under the law, the federal government guarantees the purchase of such products, which likely would not have a high demand in the private market, to provide companies with incentive to invest in research and development. The law also allows for the emergency distribution of such products before they receive FDA approval (California Healthline, 7/22). Sens. Joseph Lieberman (D-Conn.) and Orrin Hatch (R-Utah) said at the hearing they would introduce a bill called BioShield II early next year that would "provide tax incentives, intellectual property protections and some liability shields to encourage firms to undertake the costly research needed to develop antidotes and vaccines," CQ Today reports. The intellectual property measure would allow a drug maker that has successfully created a bioterror countermeasure to extend for two years a patent on an existing commercial product of the company's choosing.
Senate HELP Committee Chair Judd Gregg (R-N.H.) said there has been an "anemic response" from companies to BioShield. "Less than 100 companies have actually come forward and said they have an interest in pursing biologics," he said. Officials from pharmaceutical companies, who spoke at the hearing, raised concerns about their liability if products developed for the government had adverse side effects.
"The issue of potential liability for any entity that provides, or performs research and development related to, bio-defense countermeasures absolutely must be addressed in order to stimulate private sector interest," Aventis Pasteur Vice President Christine Grant said.
Generic Pharmaceutical Association President Kathleen Jaeger said the proposed intellectual property provision under BioShield II "adds significant uncertainty regarding access to affordable medicines for our nation's health care system" (CQ Today, 10/6). Sen. Charles Schumer (D-N.Y.) said if the patent extension provision is adopted, a company could do "$20 million worth of research on an existing drug" as a bioterrorism vaccine, "then claim a $3 billion patent extension on one of its blockbuster drugs" (Rovner, CongressDaily, 10/6).
Sen. Patrick Leahy (D-Vt.) said he has "serious concerns about the wide-ranging consequences of this bill. It strikes me as giving everything but the kitchen sink away to the brand pharmaceutical industry" (CQ Today, 10/6). Jaeger added that the measure would give brand-name drug makers "a blank check." Former president of the Infectious Disease Society of America John Bartlett said any follow-up bill should contain incentives for companies to develop antibiotics, which under the current BioShield law are disqualified from funding because they have commercial value (CongressDaily, 10/6).