Underscoring the importance of a fully funded U.S. Food and Drug Administration (FDA) in advancing progress in cancer, the American Association for Cancer Research (AACR),the world?s oldest and largest professional organization dedicated to advancing cancer research, earlier this week called on the U.S. Congress to support the agency?s budget increase recently approved in the U.S. Senate.
?The Food and Drug Administration is the vital nexus between discoveries in cancer research and continued improvements in patient care,? said AACR President Judy Garber, M.D., M.P.H. ?We need to ensure the FDA has the resources to integrate advances in science and technology into the regulatory process to keep pace with medical product innovation. Patients will be the ones who suffer if the FDA budget falls victim to shortsighted budget cuts.?
The FDA currently operates on annual appropriations of about $2.4 billion. In early November, the Senate passed a FY2012 appropriations measure that boosted the FDA?s budget by $50 million, which contrasts sharply with the $285 million cut to the agency passed by the House earlier this year. House and Senate members are now negotiating a compromise between the two versions. Meanwhile, there are also concerns that the FDA may be a target for the Joint Select Committee on Deficit Reduction, which is tasked with releasing a plan by Nov. 23 to identify $1.2 trillion in deficit reduction over 10 years.
Concern
These funding uncertainties will be a looming topic of concern as thousands of academics, scientists and representatives from the pharmaceutical industry convene in San Francisco this weekend for the AACR-NCI-EORTC International Conference: Molecular Targets and Cancer Therapeutics to discuss innovations in drug development, target selection and the impact of new discoveries in molecular biology.
Modernizing the regulatory process
?Rapid advancements in molecular biology and genetics are leading to an abundance of new targets for cancer therapies,? said Frank McCormick, Ph.D., FRS, chair of the AACR Task Force on Regulatory Science and Policy, which was established with the goal of supporting FDA efforts to improve and modernize the regulatory process. ?The excitement in this field is palpable, but it is tempered by anxiety over what is happening on Capitol Hill. These discoveries won?t advance to patients quickly enough unless Congress adequately funds the FDA.?
According to a recently released FDA report, the agency has approved 35 new medicines during the past 12 months, among the highest number of approvals in the past decade and surpassed only by 2009. Seven of the new medicines represent major advances in cancer treatment.
?The science underlying these new innovations is expanding at an incredible speed, as we will see at the upcoming AACR-NCI-EORTC conference,? said Margaret Foti, Ph.D., M.D. (h.c.), chief executive officer of the AACR. ?It is absolutely essential that Congress provide the FDA the resources needed to keep pace and continue to drive new breakthroughs quickly through the drug development pipeline to patients.?
