“A government crackdown on cheaper copies of Ozempic and similar diabetes and weight-loss drugs was intended to shut the door on that booming market. It hasn’t exactly worked out that way,” Alex Janin writes over at The Wall Street Journal. “Instead, some compounding pharmacies and telehealth companies that make the copies have found new ways in. They are making and selling dosages slightly different from the standard, F.D.A.-approved amounts or including additives such as vitamins B3 and B12. Others have changed how the drug is taken, switching from injectables to under-the-tongue drops or pills. These providers are relying on a law that allows bespoke versions of drugs that are unavailable commercially. Though some patients report delays in receiving the compounded medications, many are still getting them — at least for now — said patients and industry professionals. Patients originally turned to these less-expensive alternatives not approved by the Food and Drug Administration because their insurance didn’t cover the brand-name drugs. But the F.D.A. recently set spring deadlines for compounders to stop providing the copycat drugs. Jessica Nelson, 28 years old … turned to a telehealth platform called Emerge for a compounded version of tirzepatide last fall, when her health plan denied coverage of the branded versions, Mounjaro and Zepbound. This spring, Emerge notified her that it was switching pharmacies and adding niacinamide, a form of vitamin B3, and then levocarnitine, an amino acid, to the formulations. Nelson, who has lost 50 pounds on the medication, said she would prefer that there weren’t any additives. ‘But if it’s that or nothing, then I would still take it,’ Nelson said. She pays $379 a month, less than half of what brand-name alternatives cost until recently. … A long-running shortage of blockbuster obesity drugs allowed compounding pharmacies to make cheaper copies over the past few years — and the market for them to explode. … Now that the F.D.A. has declared an official end to the shortages, providers are required to stop making the compounded copies in bulk. A section of the Federal Food, Drug and Cosmetic Act still permits compounding if the drug is changed in a way that makes a significant difference’ for the patient compared with the commercially available drug. … In March, the telehealth site Clover Meds emailed customers to say that its compounded tirzepatide would soon be prescribed only to people who had excessive nausea with standard formulations. Patients would be prompted to answer a question to determine eligibility, the email said. The drug would change to a twice-weekly injection with vitamin B6 to mitigate nausea. Southend, a compounding pharmacy, emailed its patients to say that it was tweaking several dose concentrations to avoid being considered a ‘copy.’ Southend said that it now prescribed the drug only to patients who couldn’t tolerate the dosages of the brand-name drugs and that its prescription volumes had fallen as a result.” Alex Janin, “Ozempic knockoffs survive crackdown thanks to loophole,” The Wall Street Journal.
