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Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy. | | | | |  | | By Katherine Ellen Foley and David Lim | With Megan R. Wilson
| | |  Commonly used chemotherapies are in severely short supply in the U.S. | Gerry Broome/AP Photo | IT’S THE ECONOMY, STUPID — Razor-thin margins for generic drugmakers are behind critical drug shortages, say FDA officials, drugmakers and supply chain experts. But it appears unlikely Congress will financially support the industry — even as smaller supply-chain policy bills are mired in a partisan brawl. Republicans and Democrats say they want to pass legislation this year to address historically severe shortages of commonly used chemotherapy therapies, which has led the FDA to allow the importation of certain cancer drugs from China. More than 135 drugs are in short supply, a higher number than has been observed in several years, according to an FDA drug shortage database. Some lawmakers support granting the FDA new authority, including the ability to require drugmakers to alert the agency if demand spikes for a drug. Still, it’s unclear whether there is Republican support for the measures. The economics: The issue is particularly acute for sterile injectable drugs that require high-quality manufacturing — the most common cause of drug shortages, according to the FDA. Many generic drug manufacturers lose money on generic sterile injectable drugs, according to Lori Reilly, chief operating officer at the Pharmaceutical Research and Manufacturers of America. “We have got to fix the core economics if we are going to get the situation fixed,” FDA Commissioner Robert Califf told the House Energy and Commerce Oversight and Investigations Subcommittee last month. The White House view: A senior White House official granted anonymity to discuss the Biden administration’s efforts on drug shortages told POLITICO that lawmakers have raised “concerns about Chinese dominance in this space and what that means for American interests” when asked whether there is the legislative appetite to subsidize generic manufacturing. The FDA’s perspective: The FDA cannot force a manufacturer to manufacture a drug or compel companies to notify the agency of surges in demand that they can’t keep up with. “Something we encourage companies to do is to look at their supply chain and have built resiliency and redundancy into that system,” Valerie Jensen, the associate director of the drug shortages staff in FDA’s Center for Drug Evaluation and Research, told POLITICO. “That costs money. Unfortunately, for some of these older, cheaper drugs, that’s challenging for companies to do, but it’s something that would really help in the long run.” IT'S FRIDAY. WELCOME TO PRESCRIPTION PULSE. The USDA approved the first chicken grown from cells for sale this week — will you be giving it a try? Let us know, and send news and tips to David Lim (dlim@politico.com or @davidalim) or Katherine Ellen Foley (kfoley@politico.com or @katherineefoley). TODAY ON OUR PULSE CHECK PODCAST, Alice Miranda Ollstein and Megan Messerly take stock of what the abortion landscape looks like one year after the landmark Supreme Court ruling overturning Roe v. Wade — and you might be surprised at some of the developments that defied predictions.
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Sen. Martin Heinrich (D-N.M.) said the FDA spending bill that the Senate Appropriations Committee approved Thursday involved tough decisions, but he believes it's a "good bill." | Francis Chung/E&E News | FDA BUDGET ADVANCES — The FDA’s budget increase in fiscal 2024 will fall well short of inflation under a spending bill approved unanimously by the Senate Appropriations Committee on Thursday, POLITICO’s Ben Leonard reports. The 1 percent increase, to $6.63 billion, is in line with the amount approved by House appropriators earlier this month. It came after Democrats advanced topline spending totals on party lines — $25.9 billion for the Agriculture-FDA bill. The relatively small increase in FDA funding would go toward cosmetics oversight ($7 million), food safety programs and device and drug shortages ($3.75 million), neuroscience research ($3 million) and ALS research ($2.5 million). User fees would make up $3.07 billion of the total compared with $3.55 billion in appropriation, similar to the House plan. “We had to make tough decisions under an austere topline number, but I believe we have written a good bill,” said Sen. Martin Heinrich (D-N.M.), chair of the Appropriations Agriculture, Rural Development, Food and Drug Administration and Related Agencies Subcommittee. What’s next: House and Senate appropriators have until Sept. 30 to pass a bill or extend current funding levels to avoid a partial government shutdown.
| | | | SUBSCRIBE TO POWER SWITCH: The energy landscape is profoundly transforming. Power Switch is a daily newsletter that unlocks the most important stories driving the energy sector and the political forces shaping critical decisions about your energy future, from production to storage, distribution to consumption. Don’t miss out on Power Switch, your guide to the politics of energy transformation in America and around the world. SUBSCRIBE TODAY. | | | | | | | | | $3.2M FOR DMD’S FIRST GENE THERAPY — The FDA granted accelerated approval Thursday to Elevidys, a one-time gene therapy from Sarepta Therapeutics for Duchenne muscular dystrophy for boys ages 4 and 5 who can still walk. Sarepta CEO Doug Ingram later said in a call with investors that the first-of-its-kind treatment for the rare, fatal condition would come with a $3.2 million price tag, though it’s only administered once. In Phase II trials, the therapy generated the intended proteins, but the company is conducting an ongoing Phase III trial to see how much it benefits patients. “Nearly all infusions will be subject to a statutory discount for Medicaid or 340B discounts,” Ingram added, noting that the company also plans to ask the agency to expand the drug’s access to all patients as soon as its Phase III clinical trial concludes in September. FIRST FALL BOOSTER FILED — On Thursday, Moderna said it filed its booster shot against the XBB.1.5 sublineage of SARS-CoV-2 to the FDA for authorization, making it the first vaccine manufacturer to do so. According to the company, early clinical trial data shows its booster could generate protection against all the XBB variants of concern — though it declined to provide further details. “We have been working diligently for months to build ample supply, with doses ready to ship in time for the fall vaccination season in the Northern Hemisphere,” Stéphane Bancel, Moderna’s CEO, said in a statement. That was fast: The FDA officially recommended that manufacturers tailor their booster against the XBB.1.5 strain exactly a week ago.
| | CDC: VAPE SALES SOARED DURING THE PANDEMIC — Retailers went from selling 15.5 million e-cigarettes a month in January 2020 to 22.7 million a month in December 2022, according to a study published Thursday by the CDC. The number of disposable and sweet-flavored e-cigarettes — which the agency stressed are popular among youth — also increased during this period. The study didn’t capture online or specialty tobacco shop sales or distinguish between adult and youth e-cigarette users. The agency said more than 11 million adults vape regularly, as do roughly 2.6 million middle and high school students. The top-selling brands at the end of 2022 were (1) Vuse, (2) Juul, (3) Elf Bar, (4) NJOY and (5) Breeze Smoke. Vuse and NJOY are the only two products with some marketing orders, though the FDA is still considering whether the most popular Vuse brand product can be sold. Any e-cigarette without marketing orders is illegal, though the agency has not been taking action against many vapes still under review. Still, the FDA issued 189 warning letters on Thursday to retailers selling Elf Bar and Esco Bar products, which are sweet, disposable vapes without marketing orders.
| | PATIENT REGISTRY UNVEILED — The Centers for Medicare and Medicaid Services said Thursday that it has prepared its registry for Medicare beneficiaries to receive the Alzheimer’s drug Leqembi should the FDA grant it traditional approval. The agency requires that patients be enrolled in a database that tracks their progress over time to cover the $26,500-a-year drug. Patient advocates and some doctors have pushed back, saying a registry is unnecessarily cumbersome and would bar access to some beneficiaries. CMS says the registry will be simple and include a handful of clinical questions that providers would collect from patients anyway, including:
- The patient’s official diagnosis
- Whether they are on blood thinners or anti-clotting therapies
- Test results confirming they have the protein Leqembi targets
- Whether they have evidence of brain swelling or bleeding as a result of treatment
- Cognitive test results
July 6 is the deadline for the FDA to decide whether to grant Leqembi traditional approval.
| | Pfizer warns of a looming shortage of the only antibiotic cleared to treat syphilis in pregnant individuals, Bree Iskandar and Abdullahi Tsanni report for STAT. For Vox, Nicole Narea breaks down what happens now that the Titan search has ended in tragedy.
| | CMS proposed a plan Thursday to cover certain “breakthrough” devices under Medicare.
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