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Health Care
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Health Care
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Novo Nordisk wants its drug out of the compounding space
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The maker of Ozempic and Wegovy wants the FDA to block compounding pharmacies from making their own, markedly cheaper versions of the drugs.
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Novo Nordisk says the medications it produces are too complex for compounding pharmacies to make safely.
Novo asked the Food and Drug Administration (FDA) to add semaglutide to a list of “complex medications” that compounders are not allowed to make, regardless of shortages, pointing to potential safety risks.
The drugmaker argued in a statement that the risks of copied versions on patient health “far outweigh any benefits.”
Remember: Compounding pharmacies are legally allowed to make their own versions of drugs that are in shortage.
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Semaglutide, the active ingredient in Ozempic and Wegovy, has been in shortage for over two years now. In that time, compounding pharmacies and the telehealth companies that own or contract with them have been able to circumvent Novo Nordisk’s exclusive hold on the drug.
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Ozempic and Wegovy carry a cost of about $1,000 a month before any discounts, and many insurance plans don’t cover semaglutide for weight loss. Compounded versions sell for a fraction of the price, making them an affordable alternative.
But: Novo says those versions aren’t safe because the compounded drugs are not FDA-approved. The request to the FDA is an escalation of the company’s attempts to stop what it says is unsafe compounding, after previously filing dozens of lawsuits against compounders and telehealth companies.
Another fight: Novo’s request follows an ongoing dispute between Eli Lilly (the maker of Mounjaro and Zepbound) and compounding pharmacies.
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Earlier this month, the FDA removed tirzepatide, the active ingredient in Mounjaro and Zepbound, from its shortage list. Lilly then sent out a spate of cease-and-desists to pharmacies and medical spas selling compounded tirzepatide.
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Compounders in turn argued the shortage wasn’t over and filed a lawsuit, leading FDA to say it is currently reconsidering the move.
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Welcome to The Hill’s Health Care newsletter, we’re Nathaniel Weixel, Joseph Choi and Alejandra O’connell-Domenech — every week we follow the latest moves on how Washington impacts your health.
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Did someone forward you this newsletter? Subscribe here.
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How policy will be impacting the health care sector this week and beyond:
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FDA recalls thousands of antidepressant bottles due to cancer-causing chemical
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The Food and Drug Administration (FDA) issued a Class II recall of more than 7,100 bottles of the antidepressant duloxetine due to the possible presence of a carcinogen. Duloxetine belongs to a group of drugs called selective serotonin and norepinephrine reuptake inhibitors that are used to treat depression and anxiety, according to the Mayo Clinic. A recall of the common antidepressant drug, also sold under the brand name …
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Bird flu infects 4 in Washington state; CDC deploys team
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Bird flu has possibly infected four agricultural workers in Washington state, according to its health department. In a press release Sunday, the Washington State Department of Health said the “workers tested presumptively positive for avian influenza after working with infected poultry at a commercial egg farm in Franklin County.” Franklin County is in the eastern half of the Evergreen State, which is known for its agriculture. …
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Democrats urge appeals court to uphold hospitals’ emergency abortion care
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Nearly every House and Senate Democrat is calling on a federal appeals court to affirm that hospitals participating in Medicare must provide emergency abortion care to patients when necessary. In a brief to the U.S. Court of Appeals for the 9th Circuit on Tuesday, 259 Democrats wrote that the federal Emergency Medical Treatment and Labor Act (EMTALA) makes clear that hospitals must provide abortion as a stabilizing …
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Local and state headlines on health care:
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Under an L.A. freeway, a psychiatric rescue mission (The New York Times)
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‘Angel financier’ is funding legal effort to throw abortion off the Florida ballot (Miami Herald)
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Delta-8 hemp and Texas medical marijuana industries to face off in the upcoming legislative session (Texas Tribune)
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Health news we’ve flagged from other outlets:
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Crackdown on homeless encampments raises public health questions (The Washington Post)
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U.S. study on puberty blockers goes unpublished because of politics, doctors say (The New York Times)
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FDA approves Pfizer’s RSV vaccine for adults with increased risk of the disease (CNBC)
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Most read stories on The Hill right now:
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Nate Silver: ‘My gut says’ Trump will win
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Veteran pollster Nate Silver said his “gut” right now is that former President Trump will win the election in less than two weeks, but he cautioned … Read more
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Democrats fear race may be slipping away from Harris
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There is growing fear in Democratic circles that the presidential race could be slipping further away from Vice President Harris. To be sure, Democrats … Read more
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Opinions related to health submitted to The Hill:
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DeSantis’s latest abortion move crosses another red line of public health
- California leads the way on regulation of food additives
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