HORSE TRADING LEADS TO BIODEFENSE FUNDING, NIH REAUTHORIZATION
Both chambers of Congress passed legislation providing funding for biodefense programs and reauthorizing the NIH after a last-minute deal between Senate negotiators and Rep. Joe Barton (R-Texas), an industry source says.
The Senate and House had reached an impasse late last week on these bills as Barton refused to accept the Senate version of biodefense legislation without the Senate adopting his plan for NIH reauthorization. But negotiators in the Senate and House agreed to pass each other's bills, a Biotechnology Industry Organization (BIO) spokesman said. Meanwhile, legislation extending R&D tax credits and requiring reporting of adverse events associated with OTC drugs and dietary supplements also passed out of Congress. All four bills await the president's signature before becoming law.
Industry groups lauded these bills as important to bolster drug and biotech research and accelerate the development and introduction of new treatments. "At a time when it takes 10 to 15 years to research and develop one new drug at an average cost of $1 billion, it is important to have this key research incentive in place," Billy Tauzin, PhRMA's president and CEO, said in a statement about the R&D bill.
The biodefense legislation will help support biotechnology firms' efforts to develop new vaccines to prevent or treat pandemics and fend off bioterrorism, the BIO spokesman added. For instance, the bill, S.3678, provides grants for product testing and to facilitate manufacturing of these treatments. The market is better defined under the bill, making it "easier to attract investors to back these projects," he said.
Barton's NIH reauthorization bill, H.R.6164, authorizes the agency's budget and launches a new electronic reporting system to track NIH research. The legislation also limits the size of the agency to its current 27 institutes and centers and creates the Scientific Management Review Group to evaluate the NIH's structural organization at least once every seven years. The panel would propose potential restructuring plans for the agency.
The final bill, the "Dietary Supplement and Nonprescription Drug Consumer Protection Act," S.3546, requires manufacturers and distributors of dietary supplements and OTC drugs to report all serious adverse events associated with the use of their products to the FDA. It also requires them to keep records of other adverse events. It passed the Senate Dec. 6 and the House in the early hours of Dec. 9.