Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy.
| | | | |  | | By Lauren Gardner and David Lim | | | | | 
Sen. Bernie Sanders was able to get Novo Nordisk's CEO to testify before the HELP Committee without having to issue a subpoena. | Francis Chung/POLITICO | SANDERS NOTCHES ANOTHER PHARMA WIN — Senate HELP Chair Bernie Sanders (I-Vt.) scored another win in his latest battle with the drug industry, getting Novo Nordisk’s CEO to agree to testify about his company’s pricing for in-demand diabetes and weight-loss drugs. Flying solo: Sanders spokesperson Anna Bahr said the Health, Education, Labor and Pensions Committee’s big win was CEO Lars Fruergaard Jørgensen agreeing to testify solo instead of with pharmacy benefit manager representatives and other pharma executives. Novo agreed to send Jørgensen to the Hill in early September, a retreat from the company’s initial bid to have him testify during the last days of the Senate session before lawmakers hit the campaign trail. Still, this was a compromise from Sanders’ original bid to bring a company official before the panel on July 10. The background: The deal announced late Friday avoids a subpoena vote that had been scheduled for Tuesday and will bring Jørgensen to Capitol Hill as the sole witness at a hearing on the drug class that includes Novo’s Ozempic and Wegovy, which are both in short supply in the U.S. because of high demand. Patients in European countries pay 10 to 15 times less for the drugs, though the cost of American consumers’ prescription meds also depends on rebates and other discounts negotiated among drugmakers, pharmacy benefit managers and insurers. Sanders likely had sufficient Democratic support to issue a subpoena to compel testimony, which was targeted toward a different Novo executive who leads the company’s North American operations. Some level of GOP backing also wasn’t out of the question; Sen. Mike Braun (R-Ind.) indicated to Lauren that he was open to supporting the subpoena, and he expressed similar sentiments when Sanders threatened action against other pharma executives earlier this year. What’s next: When asked whether Sanders will turn his attention to Eli Lilly, the company behind competitor GLP-1s Mounjaro and Zepbound, Bahr said Sanders has nothing to announce yet. But she noted that he’s said his efforts to uncover why the diabetes and weight-loss drugs are so expensive aren’t targeted specifically at Novo Nordisk. IT’S TUESDAY. WELCOME BACK TO PRESCRIPTION PULSE. We can’t say that we are welcoming the return of D.C. summer heat and humidity. Send news and tips to David Lim (dlim@politico.com or @davidalim) and Lauren Gardner (lgardner@politico.com or @Gardner_LM).
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The FDA has issued long-delayed guidance for medical gases. | Manuel Balce Ceneta/AP | NEW MEDICAL GAS REGS — The FDA published new regulations Monday aimed at providing clear labeling and safety information for medical gases. Congressional pressure: The action comes about a month after Sen. Cindy Hyde-Smith (R-Miss.) pressed FDA Commissioner Robert Califf on why the agency hadn’t yet taken final action on the policy years after Congress required medical gas regulations to be updated in July 2016. “This rule involves every single part of FDA, and there has been a lot of negotiation to make sure we get it right as it affects things like veterinary health and biologics and devices and drugs,” Califf told Hyde-Smith at a Senate Appropriations Committee hearing on the Biden administration’s budget request. The final rule also creates so-called current good manufacturing practices specific to medical gases, which the FDA says will remove certain facility requirements, easing certain maintenance and cleaning requirements. “These regulations include many of the same categories of requirements as the general drug product CGMP regulations but are tailored to reflect differences in how medical gases are manufactured, packaged, labeled, stored and distributed,” the final rule states. “We are not including time limitations on production because medical gases are generally not expected to expire or degrade,” it adds. Costs and benefits: The FDA said the annual benefits from the final rule will be approximately $3.5 million and the annualized costs will be about $3 million.
| | A NEW RULE UNDER OMB REVIEW — A forthcoming tobacco regulation that will likely increase the minimum age from 18 to 21 for places with vending machines that sell tobacco products is undergoing review at the White House Office of Management and Budget. The pending final rule stems from a 2020 appropriations bill that increased the minimum age of sale for tobacco products to 21 years old. The new regulation is also slated to increase the minimum verification age for tobacco sales from under 27 to under 30, according to the description in the Fall 2023 Unified Agenda.
| | IRA BACK ON THE DOCKET — Boehringer Ingelheim takes its arguments against the Biden administration’s Medicare drug price negotiation program to federal court on Thursday. The drugmaker will argue in U.S. District Court in Connecticut that the law violates the Fifth Amendment’s due process and takings clauses, as well as the First and Eighth amendments’ protections for free speech and against excessive fines. BI alleges the program also violates the unconstitutional conditions doctrine for ordering any drugmaker that doesn’t participate to leave Medicare and Medicaid. BI makes the blockbuster diabetes drug Jardiance, one of the 10 products subject to the first tranche of negotiations. It’s the last pharma company to have its case against the law heard at the district court level.
| | OVERDOSES IN MEDICARE POPULATION — Federal researchers found that the chances of Medicare beneficiaries dying from subsequent drug overdoses significantly dropped if they received opioid use disorder medications or behavioral health services after an initial overdose. The study, published Monday in JAMA Internal Medicine, determined that among 137,000 Medicare enrollees who overdosed in 2020 and lived, more than 17 percent experienced a subsequent nonfatal overdose and 1 percent died from an overdose the following year. Despite medications like methadone and buprenorphine lowering the odds of dying from overdoses, researchers found that just 4.1 percent of the study population received opioid use disorder drugs and 6.2 percent filled a naloxone prescription.
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| | A Congressional Budget Office presentation to the American Society of Health Economists noted that spending in the 340B drug discount program grew 19 percent annually from 2010 to 2021. The FDA announced that Merit Medical Systems initiated a recall “in direct response” to another firm’s recall of unauthorized plastic syringes because they were included in some of its kits. The FDA approved Merck’s Keytruda with carboplatin and paclitaxel, followed by single-agent pembrolizumab, for adults with primary advanced or recurrent endometrial cancer. The FDA issued final guidance outlining how it plans to assign goal dates for Generic Drug User Fee Amendments, taking into consideration facility readiness. | | | | Follow us on Twitter | | | | Follow us | | | | |
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