Murray, Burr: Senate still ironing out user fee package

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 13, 2022 View in browser   By Lauren Gardner and David Lim Presented by Campaign for Sustainable Rx Pricing On Tap — The House's FDA user fee reauthorization bill could get a full Energy and Commerce Committee markup next week. But the Senate is still working on its own offering. — The GOP champion of the CURES 2.0 bill says portions of the legislation may move with the Senate's pandemic preparedness measure. — World leaders pledge $3.1 billion in new funding to fight Covid-19 worldwide. It's Friday. Welcome back to Prescription Pulse. Are we in the middle of the first quarter of the FDA legislative Super Bowl or nearing halftime? Send your thoughts 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 House E&C Chair Frank Pallone (D-N.J.) delivered opening remarks on Thursday at the Health Subcommittee markup on user fees, mental health, ARPA-H and other legislation. | AP Photo/Mel Evans HOUSE E&C HEALTH PANEL ADVANCES USER FEE PACKAGE — The House Energy and Commerce Health Subcommittee advanced legislation Wednesday that would establish an Advanced Research Projects Agency for Health and reauthorize Food and Drug Administration medical product user fee programs, as well as certain mental health and substance use disorder programs. One of the more contentious debates of the subcommittee markup centered on regulation of third-party servicers of medical devices, demonstrating the lack of appetite by committee leadership to open the user fee package to any amendments that lack broad consensus. The policy battle, which does not split down party lines, is whether Congress should define what constitutes remanufacturing of medical devices — potentially narrowing which firms can repair medical devices. "I just don't think that the policy on remanufacturing has reached a level of consensus, and it's not going to reach a level of consensus by next week," E&C Chair Frank Pallone (D-N.J.) said. "So if we tried to define remanufacturing, we would probably delay this bill weeks, if not months." Health Subcommittee Chair Anna Eshoo (D-Calif.) disagreed, arguing that members could work with FDA on potential legislative language in the next week to address the issue. Eshoo also took issue with a bill provision that would effectively overturn a court decision decided against FDA in April 2021. She told POLITICO she wasn't given a heads-up that the language — which would stipulate that contrast agents, radioactive drugs and over-the-counter monograph drugs should be regulated as drugs — would be included in the draft bill text. A potential "unintended consequence" of the provision, she said, is that it would treat eye-dropper medications as both devices and drugs for purposes of FDA regulation. "I think you pay a price when you don't have hearings to develop a foundation and understanding of what an issue is," Eshoo said after the markup. "I'm not happy about it, that language. It needs to be addressed." Lawmakers, including Pallone, told POLITICO the full committee could mark up the bill as soon as next week. Eshoo indicated she's optimistic more issues will be resolved before the next markup. "I don't anticipate big fights," she said. SENATE UFA BILL STILL TBD — The Senate HELP Committee's top Democrat and Republican told Lauren Thursday that work was continuing on their user fee package. The chamber is in session for two more weeks before recessing for Memorial Day. "We're working on the final parts of it now," Chair Patty Murray (D-Wash.) said. "Hopefully fairly soon." Ranking Republican Richard Burr of North Carolina said there haven't been early discussions yet with House lawmakers on user fees to iron out any issues pre-conference. Whither baby formula: Your morning hosts understand the user fee reauthorization process doesn't encompass the food side of FDA. But given its must-pass nature, Lauren wondered whether lawmakers might wade into legislating on the baby-formula shortage issue given its connection to FDA oversight of manufacturing facilities. Murray said she didn't know yet, while Burr questioned what specifically Congress should legislate on the issue. "The plant has petitioned the FDA to reopen. They're waiting on the FDA to sign off on that. If anybody else wanted to get into it, they'd still have to go through an FDA process that would be good manufacturing assessments, facility assessments," Burr told Lauren. "The fastest way is for the FDA to act on the request to open the Michigan facility." UPTON UPDATES ON CURES 2.0 — Rep. Fred Upton (R-Mich.) told Lauren on Wednesday that "there's been a little conversation" between House and Senate members on how to advance CURES 2.0, his legacy legislation with Colorado Democrat Diana DeGette, pieces of which have been grafted onto the user fees package. "Their vehicle is going to be probably [Richard] Burr and Patty Murray's bill on the pandemic," he said. "So we're looking ultimately to fold these together, is what I'd like to do. Those discussions have started." A spokesperson for Murray didn't respond to a request for comment. Upton said he and DeGette are receiving technical assistance for their bill from the Biden administration "and it wasn't quite ready for markup" on Wednesday. "We won't be ready by full committee next week, but in the next couple of weeks, we'll have … a new version that's reflective of the changes that took place today and over the next week, and I'm encouraged that we'll ultimately get a product by the end of the session," he said.   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.     Eye on FDA FDA POSTS MDUFA V PERFORMANCE GOALS — FDA posted the final commitment letter Tuesday for the fifth iteration of the Medical Device User Fee Amendments. The document contains performance goals and procedures for the program if it is reauthorized for fiscal years 2023 through 2027. MORE VUSE E-CIG PRODUCTS GREENLIT — FDA Thursday issued marketing granted orders to the R.J. Reynolds Vapor Company for its Vuse Vibe and Vuse Ciro e-cigarette devices and their associated tobacco-flavored e-liquid pods. The company first received marketing allowance for its Vuse Solo device in October. "All tobacco products are harmful and potentially addictive," FDA said in a press release. "Those who do not use tobacco products shouldn't start."   A message from the Campaign for Sustainable Rx Pricing:   Coronavirus GLOBAL SUMMIT COMMITMENTS — The U.S. and world leaders announced Thursday $3.1 billion in new funding for the global Covid fight during the Biden administration's second global Covid summit, POLITICO's Erin Banco, Carmen Paun and Daniel Payne report. NEARLY 1 MILLION IN U.S. DEAD — In the 27 months since the first recorded U.S. death, nearly 1 million people in the U.S. have succumbed to the coronavirus, POLITICO's Dan Goldberg and Annette Choi report. The toll is based on death certificates, but most experts believe it is an undercount, given how many diagnoses were likely missed in spring 2020 when the virus was poorly understood and testing was scarce. EMERGENT'S VACCINE WOES GREATER THAN PREVIOUSLY UNDERSTOOD — Millions more AstraZeneca and Johnson & Johnson vaccines — 400 million in total — were destroyed as a result of the lack of standards at Emergent's Bayview facility in Baltimore, according to an investigation by the key pandemic oversight congressional committees, POLITICO's Erin Banco and Sarah Owermohle report. GAO WEIGHS IN ON FDA REGULATION OF COVID TESTS — The Government Accountability Office released a reportThursday examining FDA's approach regulating Covid-19 tests throughout the pandemic. The report is generally favorable toward the FDA, noting the agency "exercised enforcement discretion" for several tests before emergency use authorization to speed test availability. "FDA officials told GAO they had concerns about the lack of review for these unauthorized tests, and as the number grew, the risks of this policy began to outweigh the benefits," the report states. GAO recommended that "FDA develop a policy for the use of enforcement discretion regarding unauthorized tests in future public health emergencies."   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.     Around the Agencies DEMOCRATS GET FTC MAJORITY — The Senate's confirmation of Georgetown University law professor Alvaro Bedoya on Wednesday ends a 2-2 partisan deadlock that kept many of Federal Trade Commission Chair Lina Khan's priorities on ice since October, POLITICO's Emily Birnbaum reports. In a recent appearance, Khan said she would revisit a study into the pharmacy benefits manager industry once Bedoya is in place. CDC OVERDOSE DATA REINFORCES OPIOIDS' DEADLY GRIP — More than 107,000 Americans died from drug overdoses in 2021, more than three-quarters of which were tied to opioids, the Centers for Disease Control and Prevention said Wednesday. The rapid jump in overdose deaths, which have risen nearly 50 percent in two years, presents another serious challenge to the Biden administration as it continues to manage dual public health crises — the Covid-19 pandemic and the opioid epidemic, POLITICO's Krista Mahr writes. Advocates for non-opioid pain-management approaches point to that record number as additional evidence that Congress and regulators should act to remove barriers to those therapies, citing the millions of Americans who begin misusing opioids after routine medical procedures. Voices for Non-Opioid Choices is urging the Senate Finance Committee to include legislation, S. 586, to provide Medicare reimbursement for non-opioid pain treatments used in outpatient settings in a mental health care package it's developing. "This problem is not going away on its own," said Chris Fox, the coalition's executive director. Pharma Moves Moderna's latest chief financial officer, Jorge Gomez, left the company shortly after joining this week because of an ongoing investigation at his former employer Dentsply Sirona into "certain matters, including financial reporting." David Meline, Moderna's former CFO, will return to the role while the vaccine maker searches for a new financial executive. Quick Hits The U.S. government is not reporting detailed data on how many or which individuals are receiving Covid-19 antiviral Paxlovid, Kaiser Health News' Hannah Recht reports. Document Drawer The Centers for Medicare and Medicaid Services on Thursday published a proposed decision memo for home use of oxygen. 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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