New Dems: Swift and Safe Approval Process is Needed to Sustain Medical Industry Innovation

May 30, 2012 Issues: Health Care

Washington, D.C. –Today, leaders of the New Democrat Coalition, chaired by Rep. Joseph Crowley (NY-7), released the following statement in support of H.R. 5651, legislation reauthorizing the Medical Device User Fee Act (MDUFA) and the Prescription Drug User Fee Act (PDUFA), which expire on September 30, 2012.

“These agreements are good for patients, good for industry and good for the FDA.  American companies have led the world in manufacturing biomedical and pharmaceutical breakthroughs, and we know that in order to build on this success we must have a safe and predictable approval process.  Today’s legislation ensures that Americans will receive high-quality, cutting-edge care as a result of an efficient and diligent approval process.” 

The MDUFA agreement increases predictability and consistency in the Federal Drug Administration’s (FDA) device review process, provides for greater agency accountability, and increases the resources available to FDA. In 2009, the medical technology industry generated $197 billion in revenue and employed over a half million workers according to Ernst & Young’s Pulse of the industry: Medical technology report

The PDUFA agreement makes similar improvements to the prescription drug approval process. In FY2012, PDUFA fees will fund 52% of the Human Drugs Program, which enables the FDA to carry out its important work reviewing new drugs. Without the approval of PDUFA, the program will lose 2,222 PDUFA-funded full-time equivalent employees, obstructing the program’s efficiency and our nation’s safe access to new, improved drugs. 

Along with the reauthorization of MDUFA and PDUFA, New Dem leaders support approval of the Generic Drug User Fee Act and Biosimilars User Fee Act, which are newly established by this legislation.

In December of last year, the New Dem’s Health Care Task Force, chaired by Rep. Allyson Schwartz (PA-13) and Rep. Kurt Schrader (OR-5), called for modernization of the FDA approval process to foster innovation, growth through competition, and timely patient access to new treatments and technologies with the help of more explicit and transparent guidelines for drug and device manufacturers. For an in-depth look at the New Democrat Coalition’s Principles for Supporting Innovation in our Nation’s Health Care System, please click here.


Statement supported by New Dem Leadership Members, led by Chair Representative Joseph Crowley (NY-7), and Vice-Chairs Representative Jim Himes (CT-4), Representative Ron Kind (WI-3), Representative Rick Larsen (WA-2), and Representative Allyson Schwartz (PA-13).

The New Democrat Coalition is dedicated to maintaining America’s standing as the world’s strongest, most successful nation. Founded in 1997, the New Dems believe firmly in the power of American ingenuity and innovation, and are focused on finding ways to foster and harness this creativity to grow our economy, create new American jobs, and ensure a safer and more secure future for our country.  For more information on the 42 member Coalition, visit the New Dems website at