Alexander: Senate Health Committee Advances “Critical” Bipartisan FDA User Fee Agreements

Posted on May 11, 2017

WASHINGTON, May 11 — The Senate’s health committee today overwhelmingly approved—by a vote of 21 to 2—the bipartisan Food and Drug Administration (FDA) Reauthorization Act of 2017—legislation sponsored by Chairman Lamar Alexander (R-Tenn.) and Ranking Member Patty Murray (D-Wash.) that includes four different user fee agreements that must be reauthorized by Sept. 30. The legislation is now ready for consideration by the full Senate.

“Today our committee took an important step in the timely reauthorization of the user fee agreements that fund the FDA, the agency that is responsible for making sure the promising research supported by the 21st Century Cures Act actually reaches patients,” said Senate health committee Chairman Lamar Alexander (R-Tenn.). “I am encouraged by today’s progress and look forward to renewing these agreements on time to bring certainty to the agency, and most importantly, to the patients and families that rely on medical innovation.”

The Food and Drug Administration Reauthorization Act of 2017, renews FDA's authority to collect user fees from the makers of prescription brand drugs, medical devices, generic drugs and biosimilars. These user fees account for over a quarter of all funding for the FDA.  The 2012 prescription drug user fee amendments (PDUFA), medical device user fee amendments (MDUFA), generic drug user fee amendments (GDUFA), and biosimilar user fee act (BsUFA) all must be updated and reauthorized by Congress before the current user fee agreements expire on September 30.

In addition to reauthorizing the four user fee programs, the legislation as passed by committee today contains over 20 provisions that were adopted in committee and were priorities for HELP Committee members, including an amendment from Sens. Collins (R-Maine) and Franken (D-Minn.) and an amendment from Sen. Hatch (R-Utah).

If the agreements are not reauthorized before the August work period, the agency will be forced to send layoff notices to more than 5,000 FDA employees. A delay in reauthorizing these agreements would delay the reviews of critical drugs and devices, while threatening America’s global leadership in biomedical innovation.

Over the last 15 months, the HELP Committee has held 15 bipartisan briefings, including some with the House Energy and Commerce Committee, to hear from FDA and industry about the reauthorization. The HELP Committee held two bipartisan hearings, on March 21 and April 4, on the medical device and drug user fees.  

The committee also passed the RAISE Family Caregivers Act (S.1028), sponsored by Sens. Collins (R-Maine), Baldwin (D-Wis.), Murkowski (R-Alaska) and Bennet (D-Colo.), which will help develop a strategy to coordinate federal programs to better support the millions of Americans who are caregivers for a family member.

The Senator’s full prepared opening remarks from the markup are below: 

So today we are marking up two bipartisan pieces of legislation:

S. 1028, Sen. Collins and Baldwin, Recognize, Assist, Include, Support, and Engage Family Caregivers Act of 2017 or the RAISE Act

S.934, the Food and Drug Administration Reauthorization Act of 2017, led by Senator Murray and me.

S.1028: The RAISE Family Caregivers Act

Senator Collins, Senator Baldwin, Senator Murkowski, and Senator Bennet –all members of this committee -- sponsored the RAISE Family Caregivers Act, and I look forward to their remarks.

This is legislation to help the federal government better support the millions of Americans – including about a million Tennesseans – who are caregivers for a family member.

Once Senator Murray and I have given our opening statements, Senators Collins, Baldwin, Murkowski and Bennet will have an opportunity to speak on their RAISE legislation.

S. 934, FDA Reauthorization Act of 2017

We 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.

The year before that, we worked in a bipartisan way to fix No Child Left Behind. That legislation passed the committee unanimously.

We have followed the same sort of bipartisan process on how we continue funding the FDA, the agency responsible for making sure the promising research supported by 21st Century Cures actually reaches patients.

We are talking about user fees – paid by manufacturers of drugs and medical devices –that account for $8 to $9 billion over 5 years and over a quarter of all FDA funding.

The reauthorizations are based on recommendations from industry and FDA after a thorough public process.

FDA posted meeting minutes after every negotiation, and held public meetings before discussions began and to hear feedback on the draft recommendations last fall.

In Congress, over the last 15 months, the HELP Committee had 15 bipartisan briefings, some of which were with the Energy and Commerce Committee as well, to hear from FDA and industry about the reauthorization.

This committee held two bipartisan hearings earlier this year on the Food and Drug Administration medical device and drug user fees, and released a discussion draft April 14th that provided two weeks for public comment.

Since then, we have worked in a bipartisan way to incorporate comments from the public and members of this committee.

The FDA Reauthorization Act, sponsored by me and Senator Murray, reauthorizes the four user fee agreements that expire at the end of September:

Prescription drug user fee act (PDUFA): accounted for over 70 percent of the brand drug review budget in FY2016

Medical device user fee amendments (MDUFA): accounted for 36 percent of the medical device review budget in FY2016

Generic drug user fee amendments (GDUFA): accounted for over 75 percent of the generic drug review budget in FY2016

Biosimilar user fee act (BsUFA): accounted for 29 percent of the biosimilar review budget in FY2016.

The manager’s amendment released Monday includes many priorities that were broadly bipartisan, and I appreciate all the members of the committee working with us to include those.

A few examples are:

Legislation from Sens. Isakson and Bennet to improve the medical device inspection process.

A provision from Sen. Hassan and Sen. Young to improve communication about abuse-deterrent opioid products.

We can discuss more about the manager’s amendment later.

We will be voting today on a few additional ideas as well.

I want to reiterate something I talked about in the first hearing – the need to keep this legislation broadly bipartisan and non-controversial to make sure we can get this done by August recess.

That means we need to report this legislation to the Senate floor today.

There are controversial items on both sides that I know members of this committee would normally be excited to support, but I ask that when examining these amendments in committee on this legislation, members keep in mind that any controversial policies that may be added here today could slow down the entire legislation, and I think none of us wants that outcome.

As we have done in the past, I will ask Senators to keep working with us to try to find a way to move forward that is not as controversial or wait until the floor to ask for a vote.

Here is the problem with missing the goal of having this to the President’s desk before August recess:

FDA will be forced to begin sending layoff notices to more than 5,000 employees to notify them that they may lose their job in 60 days. 

A FDA reviewer who gets started reviewing a cancer drug submitted to the agency in April could be laid off on October 1, before the reviewer is able to finish his or her 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.

I am glad we are taking the first step in the HELP Committee today to advance this bipartisan legislation. Today’s markup is critical to remaining on track to reauthorize the user fees before August recess. 

I look forward to our discussion and I urge support for this important legislation.