“Project BioShield II Act of 2005” was introduced by Sens. Joseph Lieberman (D-Connecticut), Orrin Hatch (R-Utah) and Sam Brownback (R-Kansas), and is intended to strengthen U.S. bioterrorism preparedness through measures that accelerate the development novel countermeasure agents.
The bill includes product liability protections, expanded tax incentives and fast-track FDA review of drug applications.
What gives generic manufactures pause is a “wild card” provision in the legislation that would allow a company a two-year patent extension.
Generic makers worry that if this were applied to a blockbuster drug, two years could translate into hundreds of millions – perhaps billions – of dollars in revenue without additional research or direct investment by the company.
The provision was intended to entice large pharmaceutical firms to develop countermeasures against bioterrorism weapons, rather than pursuing more traditionally profitable drugs.
It is expected that the wild card provision will be modified in response to opposition from the generic pharmaceutical manufacturers and new language was being considered, according to a report in The Washington Post.
The first BioShield was enacted last year. It was a $5.6 billion program designed to expand public- and private-sector research incentives to develop treatments, antidotes and vaccines that may not otherwise find a viable commercial market. The second iteration is an attempt to make the development of these niche drugs even more attractive to companies.