E&C PANEL TO MARK UP USER FEE PACKAGE — The House Energy and Commerce Health Subcommittee announced Monday it will mark up bipartisan legislation, H.R. 7667 , to reauthorize FDA’s medical product user fee programs on Wednesday at 10:15 a.m. EDT. Lawmakers on both sides of the aisle have pushed to keep the House version of the package limited to uncontroversial proposals to move it quickly through committee before August. “We must ensure the agency has the resources it needs to provide FDA’s gold standard of safety and efficacy in a timely manner for the American people,” E&C Chair Frank Pallone (D-N.J.) and Health Subcommittee Chair Anna Eshoo (D-Calif.) said in a statement. But the Senate is still finalizing its version of the must-pass user fee package and exploring attaching regulatory reforms targeting the diagnostics, dietary supplements and cosmetics sectors, according to four sources familiar with the ongoing discussions. Several other health bills will be considered at the House markup, including the Advanced Research Project Agency–Health Act and the Restoring Hope for Mental Health and Well-Being Act of 2022. Legislative luggage: Your hosts took a spin through the House bill’s section targeting “transparency, program integrity, and regulatory improvements” — a.k.a. rider land — and came across this barnburner: “Public docket on proposed modifications to approved strategies.” Under that provision, HHS would have to hold a public comment period on “factors related to patient access to a drug that is subject to a risk evaluation and mitigation strategy and the administration or prescribing of such drug by health care providers that should be taken into consideration when a proposed modification to such strategy is reviewed” by FDA. The provision is “a priority for dermatologists and psychiatrists,” E&C spokesperson CJ Young said, pointing to a wintertime debacle with a patient verification website for isotretinoin — the generic name for Accutane — acne treatment users. The website crashed, leaving patients without access to their prescriptions for weeks at a time. We wonder how this might apply to other drugs — like abortion pill mifepristone — subject to Risk Evaluation and Mitigation Strategies. An amendment is planned for Wednesday that would ensure it more closely addresses vendor issues, Young told POLITICO. NEW COVID FUNDS NOT PART OF UKRAINE AID PACKAGE — Democrats in Congress have agreed on a $39.8 billion package to support Ukraine, POLITICO’s Sarah Ferris and Burgess Everett report. But the agreement leaves out new pandemic preparedness dollars the Biden administration has argued are necessary to prepare for new Covid-19 surges. President Joe Biden informed congressional leaders that he wanted Ukraine and Covid aid to move separately because of Republican threats of voting down a package of those two rolled together, according to another person familiar with the request who also spoke on condition of anonymity. That person said Biden still wants to pass a Covid aid package as a separate bill that would originate in the House. “Without timely COVID funding, more Americans will die needlessly,” Biden said in a statement. “We will lose our place in line for America to order new COVID treatments and vaccines for the fall, including next-generation vaccines under development, and be unable to maintain our supply of COVID tests.”
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