| | | | |  | | By David Lim and Lauren Gardner | | | | | | | 
The House and Senate on Thursday passed a stopgap spending bill to fund the government. | Sarah Silbiger/Getty Images | FDA FUNDED, FOR NOW — The nation’s Food and Drug Administration will have enough funding to continue operating at full strength until at least March 1 after the Senate and House on Thursday passed another continuing resolution. The bipartisan accord, which prevents a partial government shutdown Saturday that would have impacted the FDA immediately, passed the Senate by a 77-18 vote and the House by a 314-108 margin. Maintaining funding levels means the FDA generally won’t be able to kick-start new programs using taxpayer funds. But the FDA receives slightly less than half of its revenues through drugmaker user fees, which insulates the agency from budgetary showdowns to some extent. Steven Grossman, executive director of the Alliance for a Stronger FDA, said the funding stopgap will let the FDA “fulfill its responsibilities,” but noted it doesn’t allow agency leaders to “do proper budget and program planning.” “The best and proper way to run an agency like FDA is to know how much money is available over the course of 12 months so that it can be spent wisely, efficiently and foresightfully,” Grossman said. House and Senate leaders reached an agreement to spend nearly $772 billion on nondefense programs. But subcommittee allocations remain uncertain, meaning it is not known how much money the FDA will receive if lawmakers reach a deal in late February on fiscal 2024 spending. IT’S FRIDAY. WELCOME BACK TO PRESCRIPTION PULSE. Snow in D.C., round two? Send news and tips to Lauren Gardner (lgardner@politico.com or @Gardner_LM) or David Lim (dlim@politico.com or @davidalim).
| | | | A message from the Coalition for Affordable Prescription Drugs: A new report from Matrix Global Advisors (MGA) found that 9 of the 10 prescription drugs with the highest price increases since 2018 DO NOT have rebates. This new data adds to a growing body of work refuting drug companies’ claims that rebates drive up drug prices. The report concludes that to combat high and rising prescription drug prices, Congress should focus on policies that promote drug competition. Read the full report. | | | | | FDA BLOWS PAST DIVERSITY PLAN DEADLINE — The FDA missed a congressionally mandated Dec. 29 deadline to issue or revise guidance for how and when drug and device companies must submit diversity action plans for clinical trial research. Congress has made clinical trial diversity one of its top priorities for the FDA, addressing it in legislation passed in recent years. An FDA spokesperson said the agency “is actively working on drafting these recommendations.” “Ensuring clinical trials for medical products are reflective of the product’s intended population is imperative to FDA’s review of a product’s efficacy and safety,” the spokesperson said. CMS, FDA LINK ARMS ON LDT STANCE — The FDA and CMS want clinical laboratories to know they are on the same page when it comes to laboratory-developed test regulation. Top officials from the two agencies issued a joint statement on Thursday, noting that CMS supports the FDA’s proposal to subject tests developed and used within a single laboratory to greater oversight. The statement comes as certain industry players argue CMS is equipped to oversee an overhaul of lab test regulations. CMS oversees quality standards for lab testing, but an expansion of that program is not the right approach and would result in “more government bureaucracy and inconsistencies,” the agencies said. “CMS does not have the expertise to assure that tests work; the FDA does,” Dora Hughes, CMS acting chief medical officer and Jeff Shuren, FDA medical device director, wrote. “Applying the same oversight approach to laboratories and non-laboratories that manufacture tests would better assure the safety and effectiveness of LDTs and would remove a disincentive for non-laboratory manufacturers to develop novel tests that can be available to and used by many laboratories for many patients.” The joint statement comes on the heels of the retirement of top diagnostics regulator Timothy Stenzel, who left the FDA at the end of 2023. Courtney Lias, director of the FDA’s Office of Gastrorenal, ObGyn, General Hospital and Urology Devices, is serving as acting director of the agency’s diagnostic office while the agency conducts a national search to fill the role.
| | | | JOIN 1/31 FOR A TALK ON THE RACE TO SOLVE ALZHEIMER’S: Breakthrough drugs and treatments are giving new hope for slowing neurodegenerative diseases like Alzheimer’s disease and ALS. But if that progress slows, the societal and economic cost to the U.S. could be high. Join POLITICO, alongside lawmakers, official and experts, on Jan. 31 to discuss a path forward for better collaboration among health systems, industry and government. REGISTER HERE. | | | | | | | | | 
Justice Elena Kagan brought up the FDA during oral arguments. | J. Scott Applewhite/AP Photo | KAGAN NODS TO FDA IN CHEVRON CASE — A Supreme Court justice cited a decades-old FDA lawsuit during Wednesday’s oral arguments challenging the future of Chevron deference, a legal doctrine that’s allowed federal agencies to fill in the gaps left by Congress when writing regulations that implement laws. Justice Elena Kagan pressed Roman Martinez, an attorney for a fishing company challenging a Commerce Department rule at the heart of the case, to tell the court whether “a new product designed to promote healthy cholesterol levels” is “a dietary supplement or a drug.” He said it would be a legal question for the court to decide rather than the agency. Kagan’s question was a callback to cholestin, which the FDA determined in 1998 was an unapproved drug due to the presence of statin compounds. Cholestin’s maker challenged the agency in court, arguing the product was actually a supplement. “That’s one of probably thousands of examples of why Congress paints with a broad brush in statute and delegates administrative agencies to put the leaves on the trees,” Marc Scheineson, an Alston & Bird law firm partner and former FDA associate commissioner under George H.W. Bush, told Prescription Pulse. Eliminating that deference to agencies, Scheineson said, would “paralyze” the FDA. “The more certainty, the better” for companies to get their products to market, he said.
| | | | A message from the Coalition for Affordable Prescription Drugs:   | | | | | SANDERS SETS PHARMA CEO SUBPOENA VOTE — The Senate HELP Committee is expected to vote on Jan. 31 whether to subpoena two pharma CEOs to testify before the panel on prescription drug prices, Lauren reports. Bristol Myers Squibb CEO Chris Boerner has agreed to testify before the committee "alongside at least one of the other pharmaceutical CEOs," the committee said in a statement. But the leaders of Johnson & Johnson and Merck haven’t committed to doing so, spurring Chair Bernie Sanders to announce the votes on Thursday. “As the HELP Committee considers legislation to lower prescription drug prices, it is critical that these CEOs explain how they determine the price of medicine in the United States,” the Vermont independent said in a statement. Companies strike back: In a letter sent to the committee last week, a lawyer for J&J took issue with the hearing’s structure, noting that the Democratic majority invited representatives of three companies that are suing the federal government over Medicare’s first drug price negotiation program. The company had offered another senior executive to testify instead. The committee’s focus "raises significant concerns that the hearing is intended as retribution for the companies’ decisions to exercise their rights to challenge a statute that inappropriately infringes on constitutionally protected freedoms,” Covington & Burling attorney Brian D. Smith wrote to Sanders. An attorney for Merck made similar arguments in a separate letter sent to Sanders, the company said Thursday. CARTER GETS A SUBCOMMITTEE — Rep. Buddy Carter (R-Ga.) — the House Energy and Commerce Committee’s resident pharmacist — has a new title. E&C Chair Cathy McMorris Rodgers (R-Wash.) announced Thursday that Carter will take over as chair of the Environment, Manufacturing and Critical Materials Subcommittee with Rep. Bill Johnson (R-Ohio) departing Congress at the end of the month.
| | | | Enter the “room where it happens”, where global power players shape policy and politics, with Power Play. POLITICO’s brand-new podcast will host conversations with the leaders and power players shaping the biggest ideas and driving the global conversations, moderated by award-winning journalist Anne McElvoy. Sign up today to be notified of new episodes – click here. | | | | | | | | | Apple will sell its smartwatch without a blood-oxygen measurement feature after losing a patent dispute, The New York Times’ Tripp Mickle reports. List prices on 775 brand drugs were raised in the first half of January according to an analysis by 46brooklyn Research, The Wall Street Journal’s Jennifer Calfas reports.
| | The Pharmaceutical Research and Manufacturers of America is hiring a senior vice president for policy and research. Elizabeth Carpenter joined the trade lobby in September as its executive vice president for policy and research.
| | | | A message from the Coalition for Affordable Prescription Drugs: A new report from Matrix Global Advisors (MGA) found that 9 of the 10 prescription drugs with the largest list price increases DO NOT have rebates. Among the drugs with the highest list price increases, drugs with no rebates saw increases as high as 413% – with an average price hike of 93%. Among the top drugs with rebates, price increases were much lower – 44% on average. This data clearly refutes drug companies’ claims that rebates drive up drug prices. To combat high and rising prescription drug prices, Congress should focus on policies that promote drug competition, not limit Americans’ pharmacy benefits. Read the full report. | | | | | | | Follow us on Twitter | | | | Follow us | | | | |
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