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Mikulski Applauds Senate Passage of FDA Reauthorization of User Fee Agreements to Ensure Access to Lifesaving Drugs and Medical Devices

Press Release

Location: Washington, DC

U.S. Senator Barbara A. Mikulski (D-Md.) a senior member of the Senate Health, Education, Labor and Pensions (HELP) Committee, today announced the Senate's passage of the Food and Drug Administration (FDA) Safety and Innovation Act which reauthorizes and establishes user fee agreements between the FDA and pharmaceutical and medical device industries to ensure the availability of safe and effective medical treatments and cures. The bill passed 92-4. Now that the Senate and House have approved the FDA Safety & Innovation Act, it will move to the White house for President Obama's signature into law.

"Life science jobs are the life blood of Maryland's economy," Senator Mikulski said. "Today, we passed a bipartisan bill that will support these jobs, bring life-saving treatments to patients in need, ensure the safety of our nation's drugs and medical devices, combat prescription drug shortages, and protect the jobs of thousands of hard-working employees at the Food and Drug Administration. This bill balances 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 therapies more safe and effective. This bill demonstrates what Congress can do when we work together for the common good."

The FDA Safety & Innovation Act reauthorizes the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee Act (MDUFA), public-private partnerships that support the FDA's drug and medical device review programs, which reduce the time between the submission of a drug or device application and the FDA's ultimate decision. Since PDUFA's passage in 1992, 1,500 new drugs have been approved by the FDA. The bill also creates two new user fee programs, the Generic Drug User Fee Act (GDUFA) and the Biosimilars User Fee Act (BSUFA).

The legislation also combats drug shortages, improves the safety of our nation's drug supply chain, improves our medical device program, and incentivizes the development of new antibiotics to treat unmet medical needs.

The User Fee Agreements allow the FDA to collect fees from companies within these industries so that the FDA has the resources necessary to ensure the safety of our nation's drugs and medical devices, promote innovation, and support well-paying American jobs. They play an important role in supporting oversight of the industry while ensuring availability and affordability of new drugs, devices and treatments.

As a member of the bipartisan Drug Shortage Working Group, Senator Mikulski fought for the inclusion of provisions that will work to combat the epidemic of prescription drug shortages. She held a drug shortage roundtable which focused on the causes of our nation's prescription drug shortages, the consequences to patients and community safety, and possible solutions to prevent, reduce, and better prepare for shortages. She heard directly from Maryland hospitals, doctors, nurses and patients about the need for safe and effective treatments that are both readily available and affordable.

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