| | | | |  | | By Lauren Gardner, David Lim and Katherine Ellen Foley | Presented by The Pharmaceutical Care Management Association | | | | — Talks to reauthorize FDA user fee programs stretch into the weekend. — The FDA and the National Institutes of Health have teamed up on a public-private partnership to focus on neurodegenerative diseases. — A House panel advances legislation to update the Vaccine Injury Compensation Program for the first time in nearly four decades. It's Friday. Welcome to Prescription Pulse. Your hosts are reacquainted with the Capitol basement. Send tips, feedback and sunlight 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 Pharmaceutical Care Management Association: On behalf of 266 million Americans, Pharmacy Benefit Managers, PBMs, negotiate discounts on prescription drugs and improve patient outcomes. According to the GAO, 99.6% of rebates, or discounts, for certain Medicare-covered drugs pass through to health plan sponsors to lower costs for beneficiaries. Patients shouldn't have to worry about high manufacturer drug prices. With a PBM on her side, Brittany's monthly medication costs went from $350 to $5. Learn more about how PBMs protect patients. | | | | | | | 
Sen. Patty Murray, D-Wash., speaks during a news conference Thursday, Sept. 15, 2022, on Capitol Hill in Washington. | Mariam Zuhaib/AP Photo | FDA USER FEES TALKS DRAG ON — Lawmakers are still working to hammer out a deal to reauthorize FDA user fee programs, with negotiations slated to continue into the weekend, your hosts report. Senate Republicans are pressing for a clean five-year bill, but policy riders are still in play as the clock winds down on the number of days left on the House calendar — and as the Sept. 30 fiscal year-end deadline approaches. "I have put forward a number of fair options," Senate HELP Committee Chair Patty Murray (D-Wash.) told POLITICO Thursday. "I am working to get everyone to an agreement." FDA spokesperson Lauren-Jei McCarthy told POLITICO "it would be a shame" if Congress did not advance other provisions in the package "that would benefit public health." Lay of the land: Both chambers are wrestling over a broader stopgap measure to fund the government into December, an undertaking that's complicated by an agreement between Senate Majority Leader Chuck Schumer (D-N.Y.) and Sen. Joe Manchin (D-W.Va.) to pass a major energy-permitting package by the end of September. Industry lobbyists and some lawmakers said this week they expect the user fee package to be attached to the continuing resolution by the end of the month, meaning the timeline for an FDA deal could be influenced by other legislative priorities. The rumor mill is in full swing: Several people familiar with the negotiations suggested Thursday lawmakers were close to a deal on a clean five-year reauthorization. But information about the state of talks is being closely held by the four corners and discussions drag on. "Everyone I've heard seems to agree clean is the default — if they can come up with a rider deal, great — otherwise, it's clean," said an industry lobbyist granted anonymity to discuss the talks on Thursday afternoon. HOUSE PANEL ADVANCES VACCINE INJURY BILL — The House Energy and Commerce Health Subcommittee approved legislation, H.R. 3655 (117), on Wednesday to advance the first update to the Vaccine Injury Compensation Program in 35 years. The bill by Reps. Lloyd Doggett (D-Texas) and Fred Upton (R-Mich.) would set a minimum number of special masters appointed to the federal claims court that hears vaccine injury claims, requiring at least 10 compared to the current maximum of eight, to ease a two-year-long case backlog. But the bill was amended during the markup to remove provisions that would have raised the minimum compensation level for claimants and would have sped up the amount of time HHS has to add a vaccine to the injury table once the CDC officially recommends it. Republicans also said they want to ensure the bill's cost, which has yet to be calculated by the Congressional Budget Office, is offset before it's considered on the floor. Doggett applauded the legislative progress in a statement to POLITICO but added that more should be done. "This late in the session it was essential to have Republican support to reduce the backlog, and some were unwilling to include all of the needed reforms," 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. | | | | | | | | FDA, NIH CREATE PARTNERSHIP FOR NEURODEGENERATIVE DISEASES — Two federal health agencies announced on Wednesday are creating the Critical Path for Rare Neurodegenerative Diseases, or CP-RND. The agencies selected the Critical Path Institute, a non-profit created by the FDA as part of its Critical Path Initiative program in 2005, to convene the public-private partnership focused on bringing together experts and patients to develop therapies for ALS and other neurodegenerative conditions.
| | | | A message from The Pharmaceutical Care Management Association:   | | | | | | HHS LAUNCHES BIOMANUFACTURING EFFORT WITH FDA FOCUS — HHS launched a National Biotechnology and Biomanufacturing Initiative on Wednesday to implement President Joe Biden's executive order from earlier this week to promote domestic biomanufacturing. The effort will support the development of several FDA-specific programs, including advanced manufacturing research at the agency's drugs and biologics centers and the Advanced Manufacturing Innovation Hub in the Office of Counterterrorism and Emerging Threats.
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This image provided by the National Institute of Allergy and Infectious Diseases (NIAID) shows a colorized transmission electron micrograph of monkeypox particles (red) found within an infected cell (blue), cultured in the laboratory that was captured and color-enhanced at the NIAID Integrated Research Facility (IRF) in Fort Detrick, Md. | NIAID via AP Photo | BIDEN ADMIN STUDYING TPOXX EFFICACY FOR MONKEYPOX — The Biden administration is working to figure out how effective a treatment approved in 2018 for smallpox is when administered to monkeypox patients, POLITICO's Krista Mahr reports. Last week, a clinical trial backed by the National Institute of Allergy and Infectious Diseases began to evaluate how Tpoxx, made by the New York firm SIGA Technologies, works in people. Another trial will soon begin in the Democratic Republic of Congo, where monkeypox has circulated for decades.
| | | Anne Zink, the Alaska Department of Health's chief medical officer, is now president of the Association of State and Territorial Health Officials. She succeeds Nirav Shah, director of the Maine CDC. Kristen Klesh has joined Loeb & Loeb to work on FDA and FTC regulatory issues. She previously worked for Venable LLP.
| | | | Join POLITICO Live on Tuesday, Sept. 20 to dive into how federal regulators, members of Congress, and the White House are seeking to write the rules on digital currencies, including stablecoins. The panel will also cover the tax implications of crypto, which could be an impediment to broader adoption and the geopolitical factors that the U.S. is considering as it begins to draw regulatory frameworks for crypto. REGISTER HERE. | | | | | | | | Twenty-five Republican senators wrote to HHS Secretary Xavier Becerra and CMS Administrator Chiquita Brooks-LaSure Wednesday with questions about how the new Medicare drug price negotiation program will be implemented and assessed. The FDA on Tuesday published a final rule that sets annual summary reporting requirements for the Right to Try Act. The FDA is holding an advisory committee meeting on Nov. 1 to discuss the accuracy of pulse oximeters in people with darker skin tones.
| | | | A message from The Pharmaceutical Care Management Association: For 266 million Americans, Pharmacy Benefit Managers, PBMs, work to negotiate discounts on prescription drugs and improve patient outcomes. According to the GAO, 99.6% of rebates, or discounts, for certain Medicare-covered drugs pass through to health plan sponsors to lower costs for beneficiaries.
In the face of rising manufacturer drug prices, PBMs lower drug costs by nearly $1,000 per patient every year. PBMs also enable seamless prescription drug delivery to patients, reduce drug interactions and help patients stay on their medication.
With a PBM on her side, Brittany can afford to live a healthier, happier life. Brittany's monthly medication costs went from $350 to just $5.
"My life changed from just existing to living. I was able to form meaningful relationships. I was able to keep jobs long-term and actually move up in companies because my true self was able to shine," Brittany said.
Learn more about how PBMs protect patients. | | | | | | | Follow us on Twitter | | | | Follow us | | | | |
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