| | | | |  | | By David Lim and Lauren Gardner | Presented by Blue Cross Blue Shield Association | With Megan R. Wilson
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Senate HELP Committee ranking member Bill Cassidy (R-La.) said he is unsure of the status of a bipartisan health package this Congress. | Francis Chung/POLITICO | CASSIDY TAKES AIM AT HELP CHAIR — The typical cross-aisle sniping on the Senate HELP Committee seems a tad more heated than usual ahead of a Thursday hearing on the high cost of prescription drugs. “The majority made it clear they weren’t interested in working with us to hold a serious hearing that could inform serious legislation to address this problem,” Sen. Bill Cassidy (R-La.), the committee’s ranking member, is expected to say in his opening remarks, which David obtained Monday. CEOs from drugmaker giants Johnson & Johnson, Merck and Bristol Myers Squibb are scheduled to testify after caving late last month on a subpoena threat led by HELP Committee Chair Bernie Sanders (I-Vt.). A staunch opponent of pharmaceutical industry practices, Sanders has repeatedly questioned why Americans pay more for the same drugs than other high-income nations, such as the United Kingdom and France. “The committee has devolved into CEO whack-a-mole with little to show for it,” Cassidy’s previewed opening statement says. In an interview, he told POLITICO that Sanders hasn’t “done the spadework” to understand what drives prescription drug pricing. “What about [pharmacy benefit managers], what about 340B [safety-net discounts], what about Medicaid best price, what about VA pricing, what about the hydraulic effect from those getting a discount?” Cassidy told David. Sanders did not respond to a request for comment Monday. But the latest barrage from Cassidy depicts a testy relationship between the two lawmakers as Democrats tout the first Medicare drug price negotiations. The hearing also reflects Sanders’ belief that congressional scrutiny of corporate behavior — even from the bully pulpit — can turn into tangible impact. Six months ago, Cassidy said he thought a bipartisan health care package was “absolutely” going to happen. But efforts to pull together a legislative package — which was rumored to include PBM practices, non-Medicare insulin pricing and possibly patent reform — didn’t happen. “A lot of stuff changed in the last six months,” Cassidy said. “I can’t tell you if it is coming out or when it is coming out, I used to know and I don’t anymore.” IT’S TUESDAY. WELCOME BACK TO PRESCRIPTION PULSE. Your host inquires what he should visit in Indianapolis — a city described to him as “a great American city.” Send news and tips to Lauren Gardner (lgardner@politico.com or @Gardner_LM) or David Lim (dlim@politico.com or @davidalim).
| | | | A message from Blue Cross Blue Shield Association: Make hospital pricing more fair and reasonable. It’s time for solutions that rein in health care costs, like making hospital pricing more fair and reasonable – which could save nearly $500 billion over 10 years. Learn more. | | | | | CDER GUIDANCE AGENDA — The FDA’s Center for Drug Evaluation and Research has quietly refreshed its guidance agenda for the year, adding a document on artificial intelligence. The forthcoming guidance, “Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drugs and Biological Products,” is due out sometime this year and will focus on what drugmakers should consider when using AI to generate data that supports applications for drug or biologic products, an agency spokesperson told Prescription Pulse. AI-specific guidance is notable given industry interest in deploying advanced technologies more widely — and within the Washington political establishment to get a handle on the regulatory impact of AI. Other documents of note we’ll be watching for: — An update to guidance with considerations for when complex medicines can be exchanged for copycats — Race and ethnicity data collection in clinical trials — Non-opioid drug development to treat chronic pain — A variety of guidances for compounded drugs — Patent information submissions for the Orange Book, which identifies patents on drugs approved by the FDA.
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Two high-powered House committees are weighing FDA policy this week. | Francis Chung/POLITICO | A BUSY WEEK — On the Hill, FDA policy will be front of mind the next few days. This morning, the House Ways and Means Committee will hear about chronic drug shortages, and the House Energy and Commerce Subcommittee on Oversight and Investigations is set to examine the FDA’s foreign drug inspection program. Allan Coukell, senior vice president for public policy at nonprofit generic drugmaker Civica Rx, and Julie Gralow, chief medical officer at American Society of Clinical Oncology, are among those testifying on what causes and could be done to ameliorate drug shortages. Notably, there is no FDA witness scheduled to testify on its foreign drug inspection program. But Mary Denigan-Macauley, director of public health at the Government Accountability Office, and John Claud, an FDA attorney at Hyman, Phelps and McNamara, are on the panel. Foreign inspections of makers of drugs and biologics fell precipitously during the Covid-19 pandemic, creating a backlog that the agency is working to mitigate. While the agency is ramping back up its foreign inspection program, 722 drug and biologics inspections were conducted overseas in 2023 compared with 1,258 in 2019, according to an FDA database. “This backlog could both extend the interval between inspections and reduce the resources FDA has available for other high-priority inspections,” Denigan-Macauley’s prepared remarks state.
| | | | A message from Blue Cross Blue Shield Association:   | | | | | A QUIET DEVELOPMENT IN IVERMECTIN CASE — A federal judge issued an order Monday granting in part and denying in part a sealed motion to dismiss a case challenging FDA communications against ivermectin as a Covid-19 treatment. It’s unclear what impact the decision in the U.S. District Court for the Southern District of Texas will have on the case, in which three doctors claim the FDA interfered in the practice of medicine by warning against the off-label use of an agency-approved medication. The motion, which the Department of Justice filed in December, is under seal due to confidential personal information included in the record. A DOJ spokesperson declined to comment, citing the lack of a publicly available version of the order.
| | | | FDA PANEL: BOOST PULSE OX QUALITY — An outside expert panel urged the FDA late Friday to move to improve the performance of pulse oximeters in people with darker skin tones. The advisory committee meeting on the devices that monitor blood oxygen levels is the second in recent years. Jeff Shuren, director of FDA Centers for Devices and Radiological Health, said the panel’s feedback would inform changes the agency might make to its device guidance or how it considers new applications for the products. The agency is weighing a clinical trial proposal that would require studies to include at least 24 people across a skin-tone scale. The FDA also is considering defining performance metrics for prescription and over-the-counter pulse oximeters.
| | | | DON’T MISS POLITICO’S GOVERNORS SUMMIT: Join POLITICO on Feb. 22 to dive into how Governors are wielding immense power. While Washington remains gridlocked, governors are at the center of landmark decisions in AI and tech, economic development, infrastructure, housing, reproductive health and energy. How are they setting the stage for the future of American politics, policies and priorities? How are they confronting major challenges? Explore these questions and more at the 2024 Governors Summit. REGISTER HERE. | | | | | | | | Waltz Health has joined the Pharmaceutical Care Management Association, bringing its total membership to 18 companies, Megan reports. Vernessa Pollard is now a partner and co-chair of DLA Piper’s FDA practice. She previously was a partner and FDA practice leader at McDermott Will & Emery, hat tip to POLITICO Influence.
| | | A drugmaker is researching whether an obesity drug candidate can be given at lower or less frequent doses over time while effectively helping patients lose weight and maintain it, STAT reports. A class-action lawsuit filed Monday claims that Johnson & Johnson mismanaged its workers' prescription-drug benefits program, POLITICO’s Kelly Hooper writes.
| | The FDA’s Oncologic Drugs Advisory Committee will meet on March 15 to discuss Janssen’s supplemental biologics license application for Carvykti to treat certain adult patients with relapsed or refractory multiple myeloma.
| | | | A message from Blue Cross Blue Shield Association: Commonsense solutions for more affordable health care.
Blue Cross and Blue Shield companies are committed to commonsense solutions for more affordable health care. Lower prices mean lower costs for consumers and taxpayers – and could save nearly $500 billion. Learn more. | | | | | | | Follow us on Twitter | | | | Follow us | | | | |
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