Senate HELP Committee examines submitted user fee agreements with FDA center directors following hearing with industry leaders
Today, the Senate Health, Education, Labor and Pensions (HELP) Committee held a hearing titled, “FDA User Fee Agreements: Advancing Medical Product Regulation and Innovation for the Benefit of Patients, FDA Center Directors.” This is the Committee’s second hearing to examine the commitment letters submitted by the Food and Drug Administration (FDA) and industry leaders for the reauthorization of the prescription drug, generic drug, biosimilar, and medical device user fee agreements. The first hearing was held on April 5, 2022, with industry leaders.
In his opening statement, Ranking Member Richard Burr (R-NC) underscored the FDA’s responsibility to meeting the terms of its commitments in each user fee program and reiterated Congress’ critical role in holding the agency accountable to Americans.
Ranking Member Burr’s full prepared opening statement:
“Madam Chair, I’d also like to take a moment to reflect on the passing of former Chairman Hatch.
“When the Reagan Revolution came to the Senate, Orrin Hatch became this committee’s Chair. He was a remarkable Senator and a good friend to so many of us in the Senate.
“His work in this committee, and others, is something we should all be proud of.
“Without Orrin Hatch, we wouldn’t have the generic drug industry.
“Think of how many lives have been saved because of that and how many billions have been saved on lower-cost drugs.
“He was also the author of the Americans with Disabilities Act, helping improve the lives of millions of Americans with disabilities, giving them opportunities and freedoms to live good quality lives.
“The list of what he accomplished could go on and on. I am saddened by his passing, and my heart and prayers go out to his beloved Elaine and their children, and to his friends and the staff who worked for him because I know they are hurting today, too.
“Thank you for holding this second hearing today on FDA’s user fee programs, and for working with my staff and me on policies that have the potential to go along with legislation to reauthorize them.
“The user fee reauthorizations provide one of those rare opportunities in Congress for true bipartisan work, and should be seen as a time to take a hard look at policies that affect the daily lives of Americans.
“I would bet that each person watching and participating in this hearing has already used several products today that are regulated by the FDA.
“That is why it is so important for the agency to keep pace with the advancements in the products that it regulates.
“If today’s hearing had a theme, it would be accountability. You are here today to be held accountable to the Congress and the American people.
“During the COVID-19 pandemic, FDA leveraged its authorities and responded swiftly to help private sector partners develop and bring tests, treatments, and vaccines to Americans in record time.
“I was thrilled that the agency embraced the letter and spirit of the law.
“But this seems to be the exception, reserved for emergencies, and not the rule. COVID-19 was a crisis, and you acted fast, but a diagnosis of cancer and or Alzheimer’s is also a crisis for families facing this news each day.
“The agency needs to apply practices it used during the COVID response to its every day operations to help speed not only the review of products, but their development as well.
“Why shouldn’t we expect you to treat more things with the same urgency you applied to the pandemic?
“As we learned during the pandemic, FDA has a fractured framework for clinical tests. It has blind spots where some of the most important tests for patients and their doctors are concerned – like genetic tests.
“I want to work on updating FDA’s regulation of diagnostic tests, and I am working with the Chair to update the regulation of other products like cosmetics and dietary supplements, too.
“I am glad the chair is interested in rolling up her sleeves with me on each of them.
“But there is an elephant in the room. The FDA has a responsibility to meet the terms of the commitments it has made for the user fee programs.
“Based on my evaluation, you have not fully delivered.
“During the last two decades, I have legislated major reforms at FDA across almost all of its programs:
“The 1997 user fee bill was my bill, FDAMA. It brought needed reform to streamline drug review, established risk-based regulation of medical devices, and required the agency to be more flexible with the types of evidence it considers for the products it regulates.
“In 2010, I worked with Senators Judd Gregg, Ted Kennedy, Lamar Alexander, and others to write the Food Safety Modernization Act, aimed at reducing foodborne illness and deaths, and modernizing the food safety programs at the agency.
“In 2012, I worked with late Senator Tom Coburn to hold FDA more accountable, reduce product review times, and address culture challenges at the agency to reinforce that review speed matters – especially to patients with a ticking clock.
“In 2013, this Committee worked to provide regulatory certainty for compounded drugs, and I worked to ensure the agency had the track and trace authorities it needed improve its ability to detect unsafe, counterfeit medicines.
“However, I have also been the roadblock to many proposals when I feared the agency was not ready for the role Congress wanted it to play, or its mission was at risk.
“I have also objected to giving FDA new or expanded authorities that they shouldn’t have, especially when FDA fails to address my concerns about accountability.
“I fought against the passage of the 2009 tobacco law, because I knew the FDA didn’t have what it takes to regulate these products.
“Thirteen years and more than $7.5 billion later, and it has authorized only one vapor product. Only one potentially less harmful alternative for life-long smokers.
“I held the 2012 user fee bill on the Senate floor and spoke for hours to run through my longstanding concerns with the user fee programs, and FDA’s posture that a user fee bill could be dropped in the lap of the U.S. Senate and passed without question.
“I have fought to uphold FDA’s gold standard of review, including when other agencies thought they could perform FDA’s function better.
“I deeply value and believe in the mission of the Food and Drug Administration, which is why the commitments that FDA makes are so important, and the goals it misses are so concerning.
“The user fee legislation that will come before this Committee for a vote in just a few weeks must hold the FDA accountable for its actions and inactions.
“Accountability is not an option. You don’t get to set goals you know you can meet and pretend that’s accountability.
“Each of the new agreements this Committee is evaluating reflect major new commitments. More money, more staff, more government.
“But what are we to do about previous commitments that went, or remain, unfulfilled?
“For the drugs program: In fiscal years 2019 and 2020, FDA missed 12 out of 14 user fee goals in the new drug program related to product development meetings with sponsors – leaving the innovators in limbo.
“Meeting only two of 14 goals is a 15 percent success rate. I believe that would be an ‘F’ pretty much everywhere.
“For the biosimilars program: In fiscal year 2020, FDA only reviewed 50 percent of applications on time. And, FDA missed seven out of 15 goals related to biosimilar product development meetings.
“Fifty percent and seven of 15 goals would also be an ‘F.’
“And, for the medical device program: Not only will FDA be three months late in finalizing an agreement, it took so long because you refused to acknowledge that the agency didn’t meet all its goals from the last time around.
“And now, the FDA wants double the money for mediocre performance improvements, and, for certain devices, longer review times.
“But the missed commitments don’t stop there.
“Missing explanations on deficiency letters, a carryover balance the size of a whole year of user fees, and the failure to finalize a guidance critical to some of the most advanced products in the field.
“More money. Lower expectations of accountability. No accountability for past failures.
“Add on top of this, a new, costly program aimed at shepherding certain devices through the review process for which FDA has zero clear deliverables. When you already essentially have this authority because I already gave it to you.
“And you expect Congress to rubber stamp these agreements? My friends, I don’t think so.
“After two transformative, challenging years at FDA, I know you can do better. The American people saw you do better, and you have an opportunity today to convince me that the agency is on the right path for patients.
“The more you use the user fees process to bully dollars out of industry, holding them hostage in the negotiating room, the less accountable FDA is to the American people and their elected representatives. Period.
“American patients deserve user fee programs that bring medicines to them on time, that keep pace with technology, that reduce the time and cost of development of treatments, and that do not grow just to put more government between patients and cures.
“I come to this process as a good faith partner to my colleagues and as a long standing advocate of the FDA, but not as a doormat.
“This Committee has never shied away from difficult FDA policy discussions.
“I promise that this process will be thorough and critical, so that the agency can rise to the challenge of the next generation of scientific advancements to improve the lives of Americans.
“I know you can do it. And with just a little more accountability added to these programs, I am optimistic that my colleagues and I will be able to get these agreements signed into law.
“But if there’s not more accountability, I see no reason why I shouldn’t stand in the way.
“I thank the chair.”