FDA user fee reauthorization inches forward

Presented by Campaign for Sustainable Rx Pricing: Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy.

May 10, 2022 View in browser   By Lauren Gardner and David Lim Presented by Campaign for Sustainable Rx Pricing On Tap — The House E&C Health Subcommittee schedules a markup of user fee legislation and other health care bills. — Congress is moving ahead with a nearly $40 billion aid package for Ukraine, but it does not include new funds to combat the Covid-19 pandemic. — FDA's top vaccine regulator signals the tentative vaccine advisory panel meetings could be moved up on pediatric Covid-19 vaccines. It's Tuesday. Welcome back to Prescription Pulse. New York's Guggenheim is the latest institution to drop any mention of the Sackler name. Send tips and feedback to David Lim (dlim@politico.com or @davidalim), Lauren Gardner (lgardner@politico.com or @Gardner_LM) or Katherine Ellen Foley (kfoley@politico.com or @katherineefoley). A message from the Campaign for Sustainable Rx Pricing: As one in four Americans face financial hardship affording their prescription drugs, Big Pharma's out-of-control price hikes and bogus blame game are worsening the crisis of affordability. Big Pharma – and Big Pharma solely – is to blame for egregious drug prices. Don't be fooled by their multi-million dollar blame game to deflect attention and evade accountability. It's time for lawmakers to keep their promise to hold Big Pharma accountable in order to lower drug prices. →   In Congress Reps. Anna Eshoo (pictured) and Frank Pallone announced the House E&C Health Subcommittee will mark up H.R. 7667 on Wednesday. | Getty Images 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."   DON'T MISS DIGITAL FUTURE DAILY - OUR TECHNOLOGY NEWSLETTER, RE-IMAGINED:  Technology is always evolving, and our new tech-obsessed newsletter is too! Digital Future Daily unlocks the most important stories determining the future of technology, from Washington to Silicon Valley and innovation power centers around the world. Readers get an in-depth look at how the next wave of tech will reshape civic and political life, including activism, fundraising, lobbying and legislating. Go inside the minds of the biggest tech players, policymakers and regulators to learn how their decisions affect our lives. Don't miss out, subscribe today.     Coronavirus Peter Marks, FDA's top vaccine regulator, said FDA is willing to move up the dates of its VRBPAC meetings on pediatric Covid vaccines if agency reviewers finish their work sooner than expected. | Getty Images MARKS TO CONGRESS: FDA COULD MOVE UP VRBPAC ON KID VAX — FDA is open to moving up the tentatively held meeting dates of its independent vaccine advisory panel, the Vaccines and Related Biological Products Advisory Committee, should agency reviewers complete their work on pediatric Covid-19 vaccines more quickly than expected, Select Subcommittee on the Coronavirus Crisis Chair Jim Clyburn (D-S.C.) said Monday. Clyburn released portions of comments that Peter Marks, the agency's top vaccine regulator, made during a Friday briefing to subcommittee staff on the vaccines for the youngest kids, underscoring the pressure on FDA to move quickly to authorize shots for the only age group left without their protection. "We're not going to delay one or the other vaccines in order to take them together," Marks said, per the subcommittee. But he also acknowledged the advisory panel could consider the two vaccines together if the reviews are completed "within a short time — such as a week," the subcommittee said. Parents protest outside FDA HQ: Meanwhile, a grassroots group of parents and doctors rallied outside FDA's White Oak headquarters Monday, calling on the agency to move expeditiously to authorize Moderna's vaccine for kids under 6. The company had been expected to complete its data submission Monday for that age group. FDA declined to comment on the protest. "While the FDA has typically taken 17-20 days to conduct a review of vaccine data for all other age groups, there have been signals from the agency that it will delay review and the approval process for Moderna so that Pfizer can catch up, giving a strong appearance of the government agency giving preferential treatment and playing favorites at the cost of young children's lives," the group, Protect Their Future, said in a statement. Counterpoint: FDA officials have signaled the reviews for the youngest pediatric shots could take longer than its predecessors, given greater concerns around the adverse events that could affect the tiniest children and the impact of the Omicron variant, which didn't exist during previous vaccine trials, on the data. FDA: MESA BIOTECH RECALLS SOME PCR TESTS — FDA announced Monday that Mesa Biotech has recalled more than 6,000 of its Accula SARS-CoV-2 PCR test because certain lots have "an increased risk of giving false positive results due to contamination at the manufacturing facility."   A message from the Campaign for Sustainable Rx Pricing:   Eye on FDA PAPER LOBBY SQUARES OFF WITH DRUGMAKERS — Specialty paper mills and drug companies are squaring off as the debate over whether prescribing information should move from hard copy to online is reignited on Capitol Hill, POLITICO's Megan Wilson reports. In 2014, FDA proposed a rule to create a "single electronic labeling repository for prescribing information" and phase out the paper booklets that accompany drugs shipped to pharmacies nationwide. Congress has stopped the rule from taking effect by inserting provisions into larger spending bills to prevent the proposed rule from moving ahead or defeating amendments that would have ushered it forward.   STEP INSIDE THE WEST WING: What's really happening in West Wing offices? Find out who's up, who's down, and who really has the president's ear in our West Wing Playbook newsletter, the insider's guide to the Biden White House and Cabinet. For buzzy nuggets and details that you won't find anywhere else, subscribe today.     Coming Up in Pharma TUESDAY: FDA vaccine regulator Peter Marks talks to the Alliance for a Stronger FDA at 1 p.m. EDT. Pharma Moves Mia Keeys is joining Hologic as director of government affairs in a few weeks. She is Rep. Robin Kelly's (D-Ill.) chief of staff. Quick Hits A scientist at a China-based company warned of potential contamination risks a year before a recall of certain blood pressure pills, Bloomberg's Anna Edney reports. Document Drawer FDA issued draft guidance Monday outlining how the agency uses benefit-risk considerations when evaluating product quality-related issues. A message from the Campaign for Sustainable Rx Pricing: Let's set the record straight: Big Pharma is solely responsible for setting and hiking prescription drug list prices — and then games the system to extend exclusivity on their products, undermine competition from more affordable alternatives in the market and keep prescription drug prices high. Americans can't afford to wait any longer. Now is the time for lawmakers to keep their promises. Let's hold brand name drug companies accountable and advance market-based solutions that lower prescription drug prices once and for all. Don't let Big Pharma off the hook →     Follow us on Twitter David Lim @davidalim Lauren Gardner @Gardner_LM   Follow us

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