The Pharmaceutical Research and Manufacturers of America (PhRMA) has endorsed the FDA Safety Over Sequestration Act of 2013. PhRMA represents U.S. biopharmaceutical research and biotechnology companies devoted to discovering and developing medicines that enable patients to live longer, healthier and more productive lives.
Sascha Haverfield, Ph.D., PhRMA vice president of scientific and regulatory affairs, has released a statement on ongoing efforts in Congress to resolve the sequestration of prescription drug user fees.
“PhRMA remains concerned about the impact of sequestration on the FDA’s ability to fulfill its critical public health mission by fostering timely patient access to safe and effective new medicines and advancing regulatory science.
“PhRMA supports the FDA Safety Over Sequestration Act of 2013, which would exempt future FDA user fees from sequestration. We commend representatives Leonard Lance (R-NJ), Anna Eshoo (D-CA), Mike Rogers (R-MI) and Doris Matsui (D-CA) for their leadership on this issue.
“We also appreciate the efforts of members of the House and Senate Appropriations Committees to find a bipartisan resolution which would restore the FDA’s access to prescription drug user fees which have already been sequestered.
“Prescription drug user fees cannot, by law, be used for any purpose other than to support FDA’s human drug review program. Their sequestration does not decrease the nation’s deficit, but only serves to exacerbate the severe budgetary constraints of a historically underfunded agency. This is detrimental to patients, regulatory science and public health.”
Since 2000, PhRMA member companies have invested approximately $550 billion in the search for new treatments and cures, including an estimated $48.5 billion in 2012.