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HEALTH CARE: Murray Presses FDA Officials about Implications of not Reauthorizing User Fee Program

Mar 29 2012

Murray: I believe we need to work together to strengthen our FDA user fee system to make sure our companies can continue innovating, expanding, adding jobs, and most importantly—helping patients

WATCH the hearing.

(Washington, D.C.) – Today, U.S. Senator Patty Murray, a senior member of the Health, Education, Labor and Pensions Committee, attended a hearing addressing reauthorization of the FDA user fee agreements and strengthening the FDA and medical products industry for the benefits of patients. In Washington state, biotech companies are critical to the local economy, and employ nearly 18,000 workers directly and almost 50,000 more through the economic activity they generate. Medical device companies employ close to 9,000 Washingtonians—and support the employment of another 20,000. These industries are providing high-skilled stable jobs for many Washingtonians.  Senator Murray remains committed to ensuring the federal government continues to encourage the success and growth of these industries in her home state and across the country.

During the hearing, Murray questioned Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research, on the implications of failing to reauthorize the user fee program, and the impact this would have on employees at the FDA involved in the drug review process.  The Senator also asked Dr. Woodcock to elaborate on these implications both for the industry and for patients.  Senator Murray also questioned Dr. Jeffrey Shuren, Director of the Center for Devices at Radiological Health, to highlight some of the products or disease categories where the FDA is committed to leading the world in advancing innovation and bringing cutting edge products to patients in the U.S., and how reauthorization of the user fee agreements can support these advances.     

The full text of Senator Murray’s remarks, as prepared:

“Thank you Chairman Harkin.  And I want to thank our witnesses for taking the time to be here to discuss this important issue.

“The medical device, pharmaceutical, and biotechnology industry is working hard to find cures to diseases affecting millions of Americans.

“But the companies in this industry are also critical to local economies in communities across America.

“In my home state of Washington, biotech companies employ almost 18,000 workers directly—and almost 50,000 more through the economic activity they generate.

“And medical device companies employ close to 9,000 Washingtonians—and support the employment of another 20,000.

“And these aren’t just jobs—many of them are high-skilled, stable jobs that pay good wages.

“In other words, exactly the kind of 21st century careers we are fighting to create here in America.

“That’s why I’ve been so encouraged by the success and growth of this industry.

“It’s why I am very focused on making sure the federal government is doing what it can to make sure that success continues.

“And as we are here today discuss, it’s why I believe we need to work together to strengthen our FDA user fee system to make sure our companies can continue innovating, expanding, adding jobs, and most importantly—helping patients.

“So my first question is for Dr. Woodcock.

“If the user fee program is not reauthorized, employees at the FDA involved in the drug review process would likely be laid off. 

“If that happens, it seems to me that patients will wait longer to get more innovative products to treat their diseases that they have –and companies in Washington state and elsewhere would have even more difficulty having their products reviewed.

“Can you speak a little bit about these potential issues and what implications they would have on patients and the industry?

“Dr. Shuren—can you talk about some of the products or disease categories where FDA is committed to leading the world in advancing innovation and bringing cutting edge products to patients in the U.S.?  And how will the MDUFA agreement before us support these advances that will help patients across the country?”