Green Statement at Hearing on PDUFA Reauthorization
Energy and Commerce Health Subcommittee Ranking Member Gene Green (D-TX) spoke about the success of the Prescription Drug User Fee Agreement (PDUFA) and the need to quickly reauthorize the agreement at a subcommittee hearing titled, "Examining the Prescription Drug User Fee Agreement Reauthorization:"
Thank you Mr. Chairman. And thank you to our witnesses for being here this morning.
Today we are examining the sixth Prescription Drug User Fee Agreement or PDUFA VI.
I think it is fair to say that we all support a strong FDA that is responsive to the needs of the patient community and the innovations of scientific research and health care delivery.
I am pleased that Congress is moving judiciously through the process of reauthorizing the user fee programs and to honoring the negotiations that led to the agreements.
The Prescription Drug User Fee Act, or PDUFA, is the most mature of the user fee programs having first been enacted in 1992.
Law lays out a detailed process for reauthorization that requires FDA to negotiate with industry to develop recommendations, and that the agency solicit public input and hold public meetings, and consult with Congress and patient, consumer advocates, and other relevant parties.
The recommendations that are the result of this process must also be available publicly for a period of public comment, and ultimately are required by statute to be transmitted to Congress.
I was disappointed to see the line in the Administration's testimony that they do not stand behind these agreements and hinted towards reopening the painstakingly negotiated products.
As we know, where we are today is the results of months of work between FDA and stakeholders to examine the program, figure out what is working and what can work better, and come to an agreement on how the program should be for the next five years through a public, drawn out process.
This progress is a long one, and the statutory deadline for reauthorization is coming up quickly.
Congress has never flirted with neglecting its obligation to reauthorize in a timely, responsible manner.
I sincerely hope that holds true for the sixth reauthorization of PDUFA, along with the other user fee programs that must be reauthorized so FDA can do its work and patients maintain access to new therapies without a major disruption to the medical product ecosystem.
PDUFA was first enacted as a way to reduce the time it took FDA to review new drugs and biologics and improve access to medical treatments more quickly.
Over the years, the user fees provided under PDUFA have allowed FDA to hire additional staff, and improve the efficiency and predictability of the review process.
Prior to the first PDUFA, the median total time for FDA to approval a standard application was 28 months.
Today, the median total time to approval for a standard application has been reduced to 12 months and first cycle approval rates are at 95 percent. And the US remains the gold standard for drug approval and evaluation of safety and efficacy.
The commitment letter for PDUFA VI includes a number of performance goals meant to help the agency with recruiting and retaining the scientific and professional staff needed to keep pace with science.
For the first time, PDUFA VI also includes specified agency hiring goals.
This builds off of the hiring provisions included in 21st Century Cures that will help the agency to compete with the private sector in terms of competitive salary, and gives the agency authority to hire the scientific and technical staff needed to support medical product review.
There have been some that have criticized FDA for being a barrier to access to innovator new drugs.
This is inaccurate.
Contrary to the description by the President and others who want to roll back patient safety measures, the FDA's approval process is not slow and burdensome.
Today, more than two-thirds of novel drugs are approved first by the FDA rather than anywhere else in the world.
It is clear that PDUFA has been successful in meeting the goal of improving the efficiency of the drug review process at FDA and ensuring patients have access to novel therapies.
The policies and goals included in the agreements reflect what these stakeholders value and will help ensure advancements and improvements within the FDA and ultimately health care more broadly.
I want to thank the agency and stakeholders for their leadership on this agreement that will continue the trajectory of patient-centered innovation at the FDA.
21st Century Cures did great work to advance such reforms and help get new cures from the lab table to the bedside.
I look forward to hearing from FDA and our other witnesses about how this agreement will build on those successes and continue to advance a modern, efficient FDA and a healthy pipeline of medical breakthroughs.
Thank you and I yield back.
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