PhRMA Statement on Sequestration of PDUFA User Fees

PhRMA Statement on Sequestration of PDUFA User Fees

WASHINGTON, D.C. (June 7, 2013) – Pharmaceutical Research and Manufacturers of America (PhRMA) Vice President of Scientific and Regulatory Affairs Sascha Haverfield, Ph.D., issued the following statement today:

“PhRMA remains deeply concerned about the impact of sequestration on the Food and Drug Administration’s (FDA) ability to fulfill its critical public health mission by fostering timely patient access to safe and effective new medicines. 

“PhRMA continues to work with lawmakers of both parties through the ongoing appropriations process towards the release of sequestered FY2013 prescription drug user fees and to prevent the sequestration of these fees in the future.”

“These 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.”


 

The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading innovative biopharmaceutical research and biotechnology companies, which are devoted to discovering and developing medicines that enable patients to live longer, healthier, and more productive lives. 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 alone.

Find PhRMA Online:

For information on how innovative medicines save lives, visit: http://www.innovation.org

For information on the Partnership for Prescription Assistance, visit: http://www.pparx.org

For information on ensuring the flow of medicines during public health emergencies, visit http://www.rxresponse.org 

 

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