 Health Care |
Health Care |
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Compounding pharmacies can make tirzepatide again |
In a reversal, the Food and Drug Administration (FDA) said it will allow some compounding pharmacies to temporarily make their own versions of tirzepatide, the active ingredient in Eli Lilly's blockbuster weight loss and diabetes drugs. |
The move is a significant victory for the compounding pharmacies that sued FDA over what they said was the agency's sudden decision to remove tirzepatide from the agency's official drug shortage list earlier this month. Tirzepatide is sold as Mounjaro for diabetes and Zepbound for obesity. In a court filing late Friday, the FDA said it would reconsider its Oct. 2 decision to remove the drug from the shortage list and wouldn't pursue regulatory action against the plaintiff compounding pharmacies for making copies of it while the process is underway. During drug shortages, it is legal for compounding pharmacies to make versions of a branded drug that are essentially the same, but drugmakers argue the practice isn't safe. Major demand for anti-obesity drugs has fueled unprecedented demand, and the compounded versions of the drugs have allowed companies not normally in the drug business to start selling their own, much cheaper versions to fill the gap. The lawsuit by compounding pharmacies and a trade organization representing compounding pharmacies argued the FDA was taking away that access. In the lawsuit, the Outsourcing Facilities Association claimed that the drug is still in short supply and should therefore remain on the shortage list. Tirzepatide had been in shortage for nearly two years. Lilly has taken steps to ramp up production, and the company said all doses of Mounjaro and Zepbound are available. A spokesperson reiterated the industry's view that compounded versions are risky for patients. However, the company acknowledged that patients' experiences looking for a particular dose of medicine in their local pharmacies may vary, and specific pharmacies may not necessarily have a particular dose of the medicine in stock. |
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How policy will be impacting the health care sector this week and beyond: |
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Lawmakers on both sides of the aisle in the House and Senate are calling for COVID-era flexibilities on telemedicine services to be extended to ensure access to “necessary and life-saving treatments,” and are speaking out against a proposed rule reportedly being advanced by the DEA that would limit telemedicine prescribing. Sens. Sheldon Whitehouse (D-R.I.), Lisa Murkowski (R-Alaska), Mark Warner (D-Va.) and Marsha … |
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Coca-Cola has recalled thousands of cans of Minute Maid Zero Sugar Lemonade that were improperly labeled and actually contained the regular formula of lemonade with 40 grams of sugar, according to the Food and Drug Administration (FDA). The recall, which Coca-Cola issued in September but didn't announce publicly, applied to 13,152 cases, each with 12 cartons of 12 cans of 12 ounces of lemonade. The mislabeled product was shipped … |
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The U.S. Department of Agriculture's internal watchdog has opened an investigation into the agency's handling of violations at a Boar's Head plant that led to a multi-state listeria outbreak, according to a Democratic lawmaker. Sen. Richard Blumenthal (D-Conn.) said USDA Inspector General Phyllis Fong is looking into how the agency handled numerous reports of alleged unsanitary conditions at the plant in Jarratt, … |
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Get the Most from Your 2025 Medicare Drug Benefits | Sign up Join The Hill on Oct. 22 as we convene Open Enrollment experts, policymakers and advocates to address key changes and updates expected from 2025 Medicare open enrollment. Speakers include: Tom Kornfield, founder & CEO, MAST Health Policy Solution; Amy Niles, Chief Mission Officer, PAN Foundation; and Julia Schreiber, Program Director, Maryland Department of Aging. |
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Branch out with a different read: |
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Vice President Harris and her campaign aides swiped at former President Trump on Tuesday after the Republican presidential nominee cut short a town hall event in Pennsylvania to play songs from his playlist for the crowd. "Hope he's okay," Harris posted on the social platform X, responding to a post from her campaign that included a clip of the rally and described Trump as appearing "lost, confused, and frozen on stage." |
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Local and state headlines on health care: |
- Yes on abortion, no on Tester? A Democratic senator's struggle underscores his party's conundrum (STAT)
- Nebraska is the only state with two abortion measures on the ballot. Confusion is the point (Vox)
- This mobile clinic is bringing birth control to rural South Texas (Texas Tribune)
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Health news we've flagged from other outlets: |
- After Pfizer's coronavirus vaccine success, CEO targeted for revenue slump (The Washington Post)
- Millions of aging Americans are facing dementia by themselves (KFF Health News)
- Crisis pregnancy center's forms give rare insight into anti-abortion practices (NBC)
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Most read stories on The Hill right now: |
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Former President Trump on Tuesday sat down with the editor-in-chief of Bloomberg News for an expansive and at times confrontational interview. The … Read more |
| Former President Trump clashed with the editor-in-chief of Bloomberg News during an economic forum in Chicago on Tuesday over the GOP nominee's insistence … Read more |
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