Barbara A. Mikulski
U.S. Senator for Maryland
Mikulski Urges Timely Reauthorization of User Fee Agreements to Ensure Access to Lifesaving Drugs and Medical Devices
Mikulski Senior Member of Senate Committee Working to Reauthorize Pharmaceutical & Device Legislation; Biotech Industry Supports Nearly 90,000 Maryland Jobs
March 29, 2012
WASHINGTON – U.S. Senator Barbara A. Mikulski (D-Md.), a senior member of the Senate Health, Education, Labor and Pensions (HELP) Committee, today urged the Committee to reach bipartisan agreement to reauthorize and establish user fee agreements between the Food and Drug Administration (FDA) and pharmaceutical and medical device industries to ensure the availability of safe and effective medical treatments and cures. Senator Mikulski has been on a Maryland pharmaceutical and biotechnology listening tour to meet with members of the Maryland medical industry as the Senate HELP Committee examines the legislation, which supports the pharmaceutical and medical device industries that account for nearly 90,000 Maryland jobs and help keep families safe and healthy.
"We must act in a bipartisan fashion to quickly pass these laws in a way that ensures safety and timeliness for patients, supports our innovative companies, and ensures we do not have mass lay-offs at the FDA," Senator Mikulski said. "I have heard from many Maryland biotech and pharmaceutical companies about the desire to have better communication with the FDA. I believe these user fee agreements represent a good step in the right direction. I also strongly believe we must include provisions to combat the drug shortage epidemic sweeping our nation. I'm a member of the bipartisan Drug Shortage Working Group where our job is to ensure we have the right legislative framework with the right enforcement teeth in place to ensure that our nation's patients and health care providers are able to access the prescription drugs they depend upon."
The Committee is currently examining the reauthorization and establishment of several user fee agreements between the Food and Drug Administration (FDA) and health care industries. The Prescription Drug User Fee Act (PDUFA), the Medical Device User Fee Act (MDUFA), the Generic Drug User Fee Act (GDUFA) and the Biosimilar User Fee Act (BSUFA) will work to ensure that the FDA has the resources necessary to more quickly and safely bring our nation's drugs and medical devices to patients in need. Congress is working to reauthorize the existing programs before they expire on October 1, 2012.
The Committee also hopes to add a number of additional provisions intended to improve the safety of our nation's drugs and medical devices, incentivize the development of new and innovative antibiotics, and reauthorize the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA). As a member of the bipartisan Drug Shortage Working Group, Senator Mikulski has also been fighting for the inclusion of provisions that will work to combat the epidemic of prescription drug shortages.
The hearing, "FDA User Fee Agreements: Strengthening FDA and the Medical Products Industry for the Benefit of Patients," included two panels. The first panel consisted of Janet Woodcock, M.D., Director, Center for Drug Evaluation & Research, FDA; and Jeff Shuren, M.D., J.D., Director, Center for Devices & Radiological Health, FDA. The second panel included David Wheadon, M.D., Senior VP of Scientific & Regulatory Affairs, PhRMA; Sara Radcliffe, Executive VP, Health, BIO; David R. GAugh, R.Ph., VP for Regulatory Affairs, GPhA; David Nexon, Ph.D., Senior Executive VP, AdvaMed; and Allan Coukell, BScPharm, Director of Medical Programs, Pew.
Senator Mikulski's remarks, as prepared for delivery, follow:
"Thank you Chairman Harkin and Ranking Member Enzi for calling this hearing so that members of this committee can learn more about various user fee agreements that have been reached by the FDA, the drug and device industries governed by these programs, and patient advocacy organizations.
"I would also like to thank our witnesses for being here today—Dr. Shuren and Dr. Woodcock from the FDA; representatives from BIO, PhRMA, and Advamed, our nation's leading innovative industries; GPhA; and the Pew Charitable Trust.
"Today's hearing topic is particularly important to me. Not only because ensuring the safety of our nation's drug and medical device supply is of the utmost importance, but also because I have the distinct honor of representing Maryland, which is home to the FDA, including more than 7,000 dedicated, talented, hard-working, full-time employees who work there.
"I just want to say to Drs. Shuren and Woodcock, and all of the FDA's full- and part-time employees, I value the work you do. What you do is important to millions of middle class families and I will continue to fight for you.
"As one of Maryland's Senators, I also have the distinct honor of representing a state that is home to more than 400 biotech companies, which support approximately 90,000 well-paying jobs in Maryland. These companies are true innovators. They improve the lives of all Americans by developing the medical treatments that improve lives and save lives.
"We must reauthorize four massively important laws—the Prescription Drug User Fee Act (PDUFA), the Medical Device User Fee Act (MDUFA), the Best Pharmaceuticals for Children Act (BPCA), and the Pediatric Research Equity Act (PREA).
"We must also create two new user fee programs—the Generic Drug User Fee Act (GDUFA) and the Biosimilar User Fee Act (BSUFA). These laws work to ensure that the FDA has the resources necessary to more quickly and safely bring our nation's drugs and medical devices to patient needs.
"We must act in a bipartisan fashion to quickly pass these laws in a way that ensures safety and timeliness for patients, supports our innovative companies, and ensures we do not have mass lay-offs at the FDA.
"I am pleased that all four user fee agreements represent a strong and unified commitment from the FDA, drug and device industries, and patient groups to reduce overall review times so we can get drugs and devices to patients more quickly and better monitor post-market safety of medical products.
"If we want to reduce review times and ensure safety we must have the appropriate and expert staff at the FDA to carry out these programs. I am pleased the user fee agreements include money for the FDA to hire more review and managerial staff and train more employees.
"I am pleased that these user fee agreements acknowledge the importance of communication between the FDA, patient groups, and unregulated industries. I have heard from many Maryland biotech and pharmacy companies about the desire to have better communication with the FDA. I believe these user fee agreements represent a good step in the right direction.
"I also strongly believe we must include provisions to combat the drug shortage epidemic sweeping our nation. I'm a member of the bipartisan Drug Shortage Working Group where our job is to ensure we have the right legislative framework with the right enforcement teeth in place to ensure that our nation's patients and health care providers are able to access the prescription drugs they depend upon. Our discussion draft will be released shortly and I look forward to stakeholder feedback.
"Over the past decade the U.S. has increasingly depended upon other countries to manufacture, produce, and import the drugs that American families rely upon every day. An estimated 40 percent of all finished pharmaceuticals and 80 percent of all active pharmaceutical ingredients in medications sold in the U.S. come from foreign counties.
"The question is whether the FDA—the federal agency tasked with ensuring the safety of these drugs—has the resources and authorities necessary to do their job. I believe the recently-released bipartisan discussion draft represents a good start. I look forward to discussing that proposal today.
"I am confident that Congress can build upon the good work already done by the FDA, drug and device industries, and patient groups in putting together these user fee agreements. To put together and pass bipartisan reauthorization bills that balance the needs of our innovative industries, which are working to cure the diseases and conditions that touch all of our lives in some way with the mission and charge of the FDA to protect the public health and speed innovations that make medicines more effective and safe. Thank you."