Alexander: Timely FDA User Fee Reauthorization is “Integral to Helping Patients, Delivering on the Promise of 21st Century Cures”

WASHINGTON, D.C., April 4 — At the Senate health committee’s second hearing on the reauthorization of the Food and Drug Administration (FDA) user fee agreements, Chairman Alexander (R-Tenn.) said that a timely reauthorization is “integral to helping patients and delivering on the promise of 21^st Century Cures.”

“After reviewing the recommendations from industry and the FDA, I believe these are good agreements for patients,” Alexander said. “I look forward to working with Senator Murray and our other members to approve these agreements here in committee and move them to the floor in a timely manner, so patients and the agency and the industry have some certainty.”

Today’s hearing features witnesses representing the manufacturers of drugs and medical devices, and the patients who rely on the products they make. It follows the committee’s March 21 hearing on the user fee agreements where experts at the FDA testified about the consequences of failing to reauthorize the agreements on time.

At that March hearing, Dr. Janet Woodcock, head of FDA’s drug center, agreed that drugs to treat cancer may be delayed; Dr. Jeffrey Shuren, the head of the device center, said the center could lose about a third of its staff; and Dr. Marks, head of the biologics center, said ongoing medical research would be slowed if Congress does not reauthorize the agreement by the end of July.

“That is what the experts from FDA told us two weeks ago,” Alexander said today, “and why I am committed to working with Ranking Member Murray and members of this committee to reauthorize these 4 different user fee agreements before the August recess. … [T]he user fee agreements and ‘commitment letters’ – part of the agreements between FDA and industry that establish the agency’s commitments in exchange for the fees Congress authorizes – have gone through an extensive process.

“In Congress, while we were working on 21^st Century Cures and after it was signed into law, 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. The first of those briefings was back in late 2015. Outside of Congress, FDA posted meeting minutes after every negotiation, and held public meetings before discussions began and to hear feedback on the draft recommendations last fall.”

He continued, “Patients were involved in developing the commitment letters, and we have already begun receiving support from patient groups asking us to reauthorize the agreements expeditiously.”

Alexander’s full prepared remarks are below:

We are having our second hearing on the reauthorization of the Food and Drug Administration medical device and drug user fees.

FDA is the agency responsible for making sure that patients benefit from the promising research driven by the 21^st Century Cures Act, which this committee worked on last year in a bipartisan way, and which Majority Leader McConnell called “the most important piece of legislation” that year.

And two weeks ago, this committee heard from experts at the FDA who told us that a timely reauthorization of these user fee agreements is integral to helping patients and continuing implementation of 21^st Century Cures Act.

I asked the witnesses at the last hearing what will happen if we do not reauthorize by the end of July, 60 days before the authority to collect user fees expires, and here is what they said:

Dr. Janet Woodcock, head of FDA’s drug center, agreed that cancer drugs may be delayed, and said that patients developing resistance to existing cancer drugs may not have innovative ones approved soon enough to help them.

Dr. Jeffrey Shuren, the head of the device center, said: “We’d lose about a third of our people, and it’s not just that reviews will take longer, but the industry, which now is starting to bring their innovative technologies to the US early, sometimes first as you heard with the artificial pancreas, they’re going elsewhere.”

Dr. Marks, head of the biologics center, talked about how ongoing research would be slowed if FDA did not have the staff to provide feedback to companies and scientists:  “We have literally hundreds of investigational new drug applications that are a part of user fee programs, the ability to hold meetings in a timely manner, the ability to make sure those approvals happen in a timely manner, to get products to patients with medical needs would be adversely impacted severely.”

That is what the experts from FDA told us two weeks ago, and it is why I am committed to working with Ranking Member Murray and members of this committee to reauthorize these 4 different user fee agreements before the August recess.

As I said two weeks ago, the user fee agreements and “commitment letters” – part of the agreements between FDA and industry that establish the agency’s commitments in exchange for the fees Congress authorizes – have gone through an extensive process.

In Congress, while we were working on 21^st Century Cures and after it was signed into law, 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. The first of those briefings was back in late 2015.

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

The panel today, representing the manufacturers of drugs and medical devices, and the patients who rely on the products they make, can speak to this process.

Each of the industries represented here – prescription drug, generic drug, medical device, and biosimilar - agreed to increase the user fees going to FDA over the next five years.

I am interested in hearing why this is a good agreement for you and the companies you represent.

Patients were involved in developing the commitment letters, and we have already begun receiving support from patient groups asking us to reauthorize the agreements expeditiously.

The National Organization of Rare Diseases and Friends of Cancer Research wrote me and Senator Murray, saying: “The cancer and rare disease patient communities rely on FDA to ensure that innovative, safe, and effective treatments reach those in need. We thank the HELP and E&C Committees for moving forward with these critical funding mechanisms, and look forward to their swift and unimpeded passage.”

I look forward to hearing from the Alliance for Aging Research today on how the user fees benefit patients as they age.

After reviewing the recommendations from industry and the FDA, I believe these are good agreements for patients.

I look forward to working with Senator Murray and our other members to approve these agreements here in committee and move them to the floor in a timely manner – so patients and the agency and the industry have some certainty.

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