Biopharmaceutical Industry Supports a Strong, Sufficiently-Resourced FDA

Biopharmaceutical Industry Supports a Strong, Sufficiently-Resourced FDA

01.07.14 | By

This is the second blog post in a series of responses to Luke Timmerman’s Xconomy article, “12 Things the Pharma Industry Can Do to Rebuild Real Public Trust,” in which he says the pharmaceutical industry isn’t doing enough to deliver “big health advances.”


Contrary to Luke Timmerman’s call in his recent Xconomy article for the biopharmaceutical industry to do “something big” to support the Food and Drug Administration (FDA), PhRMA and our member companies have partnered with the FDA for more than 50 years to ensure the safety, efficacy, and integrity of medicines before and after they are approved for patient use.   We continuously strive to make the system even better and are committed to keeping the agency’s resources intact.

We stand behind an empowered Agency that is adequately resourced through enhanced Congressional appropriations. PhRMA is a founding member of the Alliance for a Stronger FDA, a diverse coalition of more than 200 patient organizations, consumer advocates, health professionals and trade associations dedicated to increasing federal appropriations so that the Agency has resources necessary to fulfill its ever-growing responsibilities.

In order to supplement scarce federal funding, the biopharmaceutical industry pays user fees on most human drug and biologic applications through the Prescription Drug User Fee Act (PDUFA).  In the last 20 years, PDUFA has resulted in timelier patient access to more than 1,500 new drugs and biologics, decreasing review times for these treatments by more than 60 percent.  These user fees have steadily increased (to more than $2 million per application in FY 2014) so that biopharmaceutical companies now fund approximately 60-65% of the cost of human drug review. 

PhRMA has been active in voicing concern over the harm of sequestration to the FDA’s ability to fulfill its critical public health mission, and joined with other trade associations to support legislation to exempt FDA user fees from sequestration.  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 to the detriment of patients, regulatory science and public health.

It may seem counterintuitive for an industry to want a strong regulator, but there is no question that the FDA’s public health oversight is essential to the patients our member companies exist to serve.  

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