Promoting CountermeasuresOne main goal of the Bush administration is to encourage private sector development of new vaccines and treatments to protect against biological warfare. After almost two years of disputes and delay, Congress approved Project BioShield in July, and President Bush signed the bill soon after. The legislation provides $5.6 billion over 10 years to stockpile vaccines and other countermeasures to biological and chemical warfare. The bill also permits the National Institutes of Health (NIH) to expedite approval of grants for countermeasure R&D, gives FDA authority to allow emergency use of not-yet-approved treatments, and encourages speedy FDA approval of these products. FDA is urging manufacturers with investigational new drugs (INDs) that may be bioterror countermeasures to come in for "pre-pre-IND" meetings to ensure that researchers conduct necessary analyses in early studies.
Legislators and industry are discussing a BioShield II bill to provide liability protection for manufacturers and additional incentives for product development. Sens. Joseph Lieberman (D-Conn) and Orrin Hatch (R-Utah) expect hearings this fall on new tax and patent provisions, such as a proposal to offer companies that develop countermeasures "wild card" patent extensions — the opportunity to apply a two-year patent extension to an unrelated patent. Lieberman also suggested adding incentives for developing new antibiotics, and other critical treatment categories may be included in the next bill.
Development of counter-terrorism treatments also may become a campaign issue. In June, Democratic presidential nominee Sen. John Kerry (D-Mass) called for building a "medical arsenal of democracy" by speeding the transition from basic discovery to clinical trials for new drugs and vaccines. Kerry has accused the Bush administration of failing to address weaknesses in the nation's bioterrorism defenses, but his proposals for responding to biological threats appear similar to the president's.