Legislation Aims to Support R&D, Vaccine Development, and Adverse Event Reporting

Washington, DC (Dec. 13)-After considerable debate and negotiation, Congress this week passed four bills poised to affect pharmaceutical and biotechnology research, development, and manufacture. All are currently awaiting signature by the President.

Bill S.3678, entitled “Pandemic and All Hazards Preparedness Act” and sponsored by Senator Richard Burr (R-NC), amends the Public Health Service Act regarding the security of public health. Among its objectives, the legislation would support efforts to develop new vaccines to prevent or treat diseases rising from pandemics or from bioterrorism, including monetary aid for product testing and manufacture in hopes of stimulating investor support.

Bill H.R. 6164, short titled “The National Institute of Health Reform Act of 2006” and sponsored by Rep. Joe Barton (R-TX), not only authorizes the agency’s budget but also sets into motion an electronic system “to uniformly code research grants and activities of the Office of the Director and all of the national research institutes and national centers.”

Bill S.3546, entitled the “Dietary Supplement and Nonprescription Drug Consumer Protection Act” and sponsored by Sen. Orrin G. Hatch [R-UT], would amend the Federal Food, Drug, and Cosmetic Act by requiring that manufacturers, packers, and distributors report to FDA all serious adverse events for their dietary supplements and over the counter drug products. Reports would be required to be submitted within 15 days of being received by the firm.

The final bill aims to extend research and development tax credits for drug and biotechnology research, according to a report by Drug Daily Bulletin.

All bills may be viewed on www.congress.gov