When Congress comes back in session this September, some heavy lifting is needed to ensure that two agencies vital to advances in biomedical research have adequate resources.
The FDA appropriations process for fiscal year 2008 continues. We appreciate the Senate’s 11% increase above the enacted 2007 budget, and see this as a first step towards a five-year effort to increase the FDA budget. We were happy to see an increase, and hope that the House will accept the Senate number. It is vital that the agency be given more funding, end of story.
Other important work on drug safety will need action in September. The Prescription Drug User Fee Act (PDUFA) reauthorization needs to be addressed since it expires at the end of September. The PDUFA reauthorization contains some key initiatives to move us forward on drug safety and address some of the concerns outlined in the IOM’s report on the topic released almost a year ago. Two areas covered in PDUFA that we are paying close attention to are the FDA Critical Path Initiative which needs more resources, and the proposed Reagan-Udall Foundation which needs to be launched immediately. We believe this Foundation can serve as the research arm of the FDA. There is a wealth of information that resides within the FDA that can be brought to bear on drug safety analysis and drug development issues.
Finally, bills for NIH appropriations will also be considered when Congress returns to session in September. The House and Senate numbers offer slight increases, and there is great concern that NIH will continue cost-cutting if more funds aren’t appropriated.
We certainly need to continue investing in medical research now, in order to accelerate medical solutions for later.
Margaret Anderson, COO, FasterCures