Q & A with Senator Alexander on FDA User Fee Agreements

Last week, the Senate health committee took the first step in renewing the Food and Drug Administration’s (FDA) user fee agreements by approving by a vote of 21–2 the bipartisan FDA Reauthorization Act of 2017 — legislation I sponsored along with our committee’s top-ranking Democrat, Sen. Patty Murray (D-Wash.). These agreements are essential to the FDA’s ability to review life-saving drugs and medical devices to make sure they are safe for patients. I’m encouraged by the overwhelming support for these agreements in our committee, and want to share a little on why it’s so important that the Senate and House finish our work and vote on reauthorization before the August recess.

First, what are the FDA User Fee Agreements?

There are four different agreements between the FDA and makers of (1) prescription drugs, (2) medical devices, (3) generic drugs, and (4) biosimilars. These agreements are all set to expire on Sept. 30 and must be renewed by Congress. These agreements allow the agency to collect fees from the makers of drugs and medical devices in exchange for more timely and predictable reviews. The legislation the committee passed last week updates and reauthorizes the current agreements, based on recommendations from industry and FDA after a thorough public process and 15 months of bipartisan work in Congress. I believe these are good agreements for patients. They include new provisions to:

· Involve patients in the drug and medical device development process to make sure innovative new drugs and devices address what patients think are most important;

· Dedicate staff to assist in the development and review of rare disease drugs;

· Improve timelines and increase guidance for drug and device combination products, such as heart stents with drugs; and

· Modernize the clinical trial process so we can start to shorten the 8–10 years it takes to develop new drugs and get them to medicine cabinets.

Why are they important?

If you have a family member with cancer, or Alzheimer’s or diabetes, you want the FDA to move as quickly as it can to get drugs and devices through the investment and regulatory process into patients’ medicine cabinets and doctors’ offices. The user fees pay one out of every four dollars that make the FDA’s work possible.

Congress ended last year passing the 21st Century Cures Act, which Leader McConnell called “the most important piece of legislation” that year. 94 Senators voted for the legislation, which also had the support of President Obama and Vice President Biden. Again, these user fee agreements fund the FDA, the agency responsible for making sure the promising research supported by 21st Century Cures actually reaches patients.

What are the consequences if there is a delay in the reauthorization of the FDA user fee agreements?

If these agreements are not renewed by the end of July, the FDA will be forced by law to send layoff notices to more than 5,000 FDA employees to notify them that they may lose their jobs in 60 days. Someone who is reviewing a new cancer drug could be laid off on October 1, before the reviewer is able to finish their work. In addition to harming patients and families that rely on medical innovation, a delay in reauthorizing the user fees would threaten biomedical industry jobs and America’s global leadership in biomedical innovation. That’s why Senator Murray and I have been working together in a bipartisan way for 15 months to get this done. We want to show the American people we can fulfill the pledge that we made with our 21st Century Cures Act, which funded life-saving research and took steps to move it to patients more rapidly.

What happens next?

I’m glad the Senate health committee took the first step in passing these agreements, which I believe are good for patients. Next, they will go to the Senate floor, where the sooner we pass the agreements, the better — to give patients, doctors, FDA reviewers, and companies certainty.

To read more about the FDA Reauthorization Act of 2017, click here.