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| By David Lim and Lauren Gardner | Presented by PBM Accountability Project | | |
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Eli Lilly's diabetes and weight-loss drugs are no longer in short supply in the U.S., says the FDA. | Scott Olson/Getty Images | NEXT UP IN THE SHORTAGE WARS — The FDA on Thursday declared — again — that the two-year shortage of Eli Lilly’s diabetes and weight-loss drugs has ended. But the battle over the status of the supply of tirzepatide, the drug's generic name — and the ability of compounding pharmacies to make copies of the drugs — is far from over.
The Outsourcing Facilities Association, which represents large compounders and sued the FDA in October after it first said the shortage was resolved, signaled it will continue its legal battle. In a status report filed with a federal court in Texas on Thursday, the association and the FDA said they’d provide an update by Jan. 2 “addressing the next steps in this litigation,” which will likely involve a motion for preliminary injunction by the OFA.
“The agency’s decision to declare the shortage over based on the manufacturer’s say-so ignores the facts, violates the law, and puts patient access at risk,” Lee Rosebush, the group’s chair, said in a statement. “The OFA will continue its efforts to hold the FDA accountable for its obligations under law and duty to the patients who depend on it for access to medical treatments.”
The FDA has already suggested that, if the group files a preliminary injunction motion, it will pause enforcement of Thursday’s decision against compounders until the court resolves the case. The FDA argument: In anticipation, the FDA outlined its procedural approach in the declaratory order it sent Lilly, noting the law doesn’t “explicitly” describe how the agency can determine whether a product is in shortage — or whether a shortage has ended — and thus is “more compatible with adjudication than with rulemaking.”
Notice-and-comment rulemaking would also conflict with the FDA’s ability to keep private the existence of a shortage — which is legally permissible if the agency thinks disclosure could harm public health — and with its consideration of confidential business information when making shortage decisions, Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a letter to the company. Enforcement discretion: The FDA order includes grace periods for different-size compounders — 60 days for small pharmacies and 90 days for larger facilities whose products are subject to the agency’s manufacturing quality rules — meaning it won’t penalize them for continuing to dispense compounded tirzepatide to patients as they transition to Lilly’s products. The Alliance for Pharmacy Compounding, another industry group, applauded the “off-ramp” but questioned the completeness of the data the FDA relied on to make its decision.
“We continue to hear from pharmacies that the FDA-approved tirzepatide drugs are not attainable from wholesalers in quantities needed to meet demand by patients transitioning from compounded to commercial versions of the drug,” APC CEO Scott Brunner said. Meanwhile, a Lilly spokesperson called the decision “a critical step towards protecting patients from the dangers of counterfeit and compounded knockoffs.”
Semaglutide, the active ingredient in Novo Nordisk’s GLP-1 drugs, is still considered in shortage, but that could also soon change. IT’S FRIDAY. WELCOME BACK TO PRESCRIPTION PULSE. Have thoughts on the year-end bill? Send your thoughts and tips to David Lim (dlim@politico.com or @davidalim) and Lauren Gardner (lgardner@politico.com or @Gardner_LM).
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 Republicans revised their spending plan after Elon Musk, left, and President-elect Donald Trump signaled that they were unhappy with the GOP's original version. | Alex Brandon/AP |
ABOUT THAT HEALTH DEAL — A slew of health care provisions, including pharmacy benefit manager reforms, an extension of the FDA’s pediatric priority review voucher program and an overhaul of drug patent rules to address overlapping patents to thwart competition, were dropped in a revised spending plan unveiled by House Republicans late Thursday afternoon. But the bill failed to advance on the House floor that evening by a 174-235 vote, failing to meet a two-thirds bar for passage under a fast-track procedure. House Minority Leader Hakeem Jeffries told reporters the proposal was “laughable” before the vote.
The new bill came after President-elect Donald Trump and Elon Musk — the co-leader of the so-called Department of Government Efficiency — called on Republicans to kill a deal House Speaker Mike Johnson had negotiated with Democrats. The result? A package that simply extends a handful of health care programs until the end of March. MAHA CAUCUS LAUNCHES — Senate Republicans are launching a Make America Healthy Again caucus to promote Robert F. Kennedy Jr.’s agenda — well before the chamber votes to install him as HHS secretary, POLITICO’s Daniel Payne writes. Sens. Ron Johnson (R-Wis.), Cynthia Lummis (R-Wyo.), Roger Marshall (R-Kan.), Rick Scott (R-Fla.) and Tommy Tuberville (R-Ala.) are its founding members. The group’s policy goals include promoting food and nonpharmaceutical interventions; encouraging agricultural practices that improve the nutritional value of food; and furthering efforts to research, prevent and treat chronic diseases.
| | | | A message from PBM Accountability Project:
Pharmacy benefit managers (PBMs) are taking advantage of Medicare and America’s seniors. It's time for Congress to act. Rein in PBMs by requiring them to increase transparency, share discounts with seniors, and delink PBM profits from the cost of medicines in Medicare. Congress must pass S. 2973 and S. 3430 this year. Learn more. | | | | | MORE E-CIG WARNINGS — The FDA issued warning letters to eight online retailers and one manufacturer Thursday for selling or distributing flavored disposable e-cigarettes that the agency had authorized. WHAT IS ‘HEALTHY’? The FDA wants food labeled “healthy” to be held to more rigorous nutrition standards, POLITICO’s Marcia Brown reports. The much-anticipated change, initially proposed in 2022 and the first update since 1994, will prevent products like sweetened cereals, white fortified bread and highly sweetened yogurts from using the label, despite previously qualifying.
The rule, which will be published in the Federal Register on Dec. 27, will automatically qualify certain “nutrient-dense” foods for use of the “healthy” label. Those foods include low-fat dairy products, beans, lean game meat, olive oil and avocados. Under the regulation, foods must meet specific limits on salt, added sugar and saturated fat. Public health groups largely praised the rule but noted it was voluntary. "Nearly three decades since the original designation was created, it was past time to update the requirements based on the latest nutrition science," said American Heart Association CEO Nancy Brown in a statement.
| | MASS COVID INJURY CLAIMS — A federal program created to compensate patients and families of those injured or killed by medical countermeasures, like drugs or vaccines, had many claims in response to the Covid-19 pandemic — about 27 times more claims than all the those submitted during the first decade of the program. According to a Government Accountability Office report released Wednesday, the Countermeasures Injury Compensation Program received 13,333 claims, which were related to the pandemic, compared with 491 claims in the program’s first 10 years. Why it matters: Many conservatives continue to rail against what they say were missteps in the Covid response, with some casting doubt on the safety and efficacy of the vaccine after reports of myocarditis — inflammation of the heart muscle — in some individuals. And Robert F. Kennedy Jr., President-elect Donald Trump’s pick to lead HHS, has criticized laws that protect vaccine manufacturers from liability lawsuits.
As of June, 75 percent of claims were still pending, according to the report. Of the 25 percent of claims completed, 3 percent were eligible for compensation, and 56 percent were related to Covid. HHS has paid roughly $6.5 million in compensation, mostly going toward eligible claims for serious injuries caused by the H1N1 vaccine, and $400,000 for injuries, including myocarditis, related to Covid.
According to the report, HHS officials said they had challenges processing the large number of claims due to staffing shortages, outdated information systems and limited scientific backing to base decisions on injuries related to Covid.
| | | | A message from PBM Accountability Project:
  | | | | | Dr. Bob Temple will retire from the FDA at the end of the year. He’s currently senior adviser for clinical science and senior adviser in the Office of New Drugs.
| | The Justice Department sued CVS this week, alleging the company knowingly filled invalid opioid prescriptions that contributed to the country’s ongoing epidemic. Medicaid gross spending on 12 diabetes and weight-loss drugs, including several GLP-1s, increased by 540 percent from 2019 to 2023, totaling $9.4 billion in 2023, HHS’ inspector general reports.
| | The CDC disclosed this week the first known case of severe illness from an avian flu infection in the U.S., Lauren and POLITICO’s Marcia Brown report. Tobacco giant R.J. Reynolds lost an appeal Thursday of competitor Altria’s win in a patent case, Reuters reports.
| | | | A message from PBM Accountability Project: There’s consensus in Congress – real PBM reform is needed NOW.
Both sides agree we need to: improve transparency, break the link that allows PBMs to tie their profits to the price of the drug, and force PBMs to share discounts with seniors.
Congress: It is time to finish the job and pass bipartisan senate bills 2973 and 3430. America’s seniors are counting on it. Learn more. | | | | |
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