Subcommittee Chair Guthrie Opening Remarks at Hearing with FDA Center Directors

and the chair I will now recognize myself for five minutes for an opening statement so uh today three important center directors for the US Food and Drug Administration are here with us to share updates about the work they oversee with their respective divisions and really appreciate you being here with the agency now collecting the highest number of user fees on record it is critical we hear from the center directors about the ongoing challenges the agency and Industry face in getting safe and effective uh products to patent patients faster in addition to reauthorizing the user fee agreements Congress granted FDA a suite of additional authorities that were signed into law in December of 2022 these include updates to ensure clinical trials are reflective of the broader patient population greater transparency for sponsors to collaborate with payers to decrease the time from a novel products approval to coverage reforms to strengthen the accelerated approval pathway and streamline processes for manufacturers to update their software without unnecessary regulatory hurdles I'm proud of the bipartisan work the subcommittee has accomplished throughout the last user fee auth reauthorization since then FDA has approved and cleared hundreds of new products our work collectively enabled the review and approval of 55 novel drugs in 2023 and the approval of almost 1,000 generic drug applications during that same time there were 23 biologics device applications in 20 biologics license applications approved in over a 100 novel devices cleared by the FDA celling gene therapy is of particular importance and interest to me and others in Congress we're on the precipice of a Renaissance in healthc care in which personalized medicine can cure otherwise incurable diseases for example among those medicines approved in 2023 were two Cutting Edge potentially Curative Gene therapies for sickle cell disease just last summer seber also approved a therapy to address underlying cause of the disease and toan muscular distrophy in boys age four to five both examples illustrate the incredible value American innovation plays in our Health Care system and the value the FDA brings to help facilitate this remarkable work that being said I have some concerns and I hope to have address today that threaten to undermine the strides we've made missteps by the Biden Administration have already caused uncertainty among innovators in these small biotechnology companies that could impede patients ability to access innovated products the repeated attacks on the accelerated approval pathway from CMS which is second guessing fda's equities to academics and payers alike insisting that these approvals are unproven or lesser than traditional review Pathways degrades public trust and an important tool the agency has to help safely and effectively get cures to patients more quickly this is also a pathway that Congress and by part Artisan Congress has repeatedly strengthened and supported the recently release Five release 5,000 page laboratory developed test or ldt rule has been tatted as a mechanism to drive more Innovation and protect patient safety un fear this complete overall of ldt Regulation will have the opposite effect instead of driving up cost of care and delaying patient access to life-saving care test developed to treat patients at the bedside to detect early stage cancer or detect Alzheimer's sooner will be subject to honorous requirements under the new regime for proposed by CD the FDA must work with Congress on a long-term solution that balances patient safety and facilitates future Innovation last year ranking member Su and I wrote Dr Marx about clinical holds according to the Wall Street Journal there was an average of 664 clinical holds which temporarily stopped clinical research between 2017 and 2021 up from 550 7 average annual HS in Prior years in response or inquir we learned that 79% of the responses to innovators questions about their applications in the holes associated with this applications for written only responses to be clear understand the complex nature of these applications but providing written responses to complex questions with no chance for a true dialogue isn't AC acceptable it is imperative for the agency to literally come to the table and work through these issues with innovators or else patients will be left left without answers and without life-saving care uh in closing I want to thank the witnesses for being here today I know your works not easy I know that our job is ass sure and your job is that we have safe and effective medications but we must know that patients are counting sometimes months if you're a parent with a child with the shange muscular distrophy the race to keep them out of a wheelchair before they get access to to medicines is real it's important and accelerated path throughs is real and important and it's been by partisan and we want to work together that's our pledge to work together to bring these Innovative Technologies uh to Mark to Market and I will yeld back and recognize the