By Robin Foster HealthDay Reporter<\/b>
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TUESDAY, Oct. 15, 2024 (HealthDay News) — Pharmacists may continue making compounded versions of the weight-loss medication tirzepatide while the U.S. Food and Drug Administration revisits its Oct. 2 decision to remove the medicine from a national drug shortage list.<\/p>\n
What prompted the FDA to reconsider its decision<\/a>? On Oct. 7, a compounding trade group filed a lawsuit<\/a> challenging the agency’s action, saying there was still a shortage of the wildly popular drug. On Friday, the FDA responded in a court filing that compounding pharmacies could continue making the drug while the agency re-evaluates its finding, NBC News<\/em> reported.<\/p>\n Shortages of tirzepatide, sold as a diabetes drug (Mounjaro) and a weight-loss medication (Zepbound), have fueled demand for compounding pharmacies to make their own versions of the medicine, which patients say are cheaper and easier to get. <\/p>\n During FDA-declared drug shortages, compounding pharmacies can make versions that are copies of the brand-name drugs in shortage.<\/p>\n But the agency\u2019s Oct. 2 announcement said pharmacies that produce large batches of medications would no longer be able to accept new orders of tirzepatide<\/a> and had 60 days to fill their existing orders.<\/p>\n The agency’s Friday filing said its latest move was \u201ceffectively the relief that Plaintiffs sought in their motion.\u201d In the filing, the agency said it wouldn\u2019t \u201ctake action\u201d against the plaintiffs and their members making compounded versions of the drugs as it re-evaluates its decision, NBC News<\/em> reported. <\/p>\n To meet demand, drug maker Lilly has taken steps to ramp up production of tirzepatide, committing billions to a new manufacturing plant dedicated to producing more of the drug, the company announced<\/a> in May. <\/p>\n Michael Ganio<\/a>, senior director of pharmacy practice and quality at the American Society of Health-System Pharmacists, said the group is still hearing reports from patients and caregivers suggesting tirzepatide continues to be hard to find.<\/p>\n \u201cThis can be the kind of thing that just takes a couple of weeks for supply to even out,\u201d he told NBC News<\/em>. \u201cDistribution centers get replenished and then they send it out to pharmacies. The pharmacies probably all have back orders and they have customers that maybe have been getting it from the compounding pharmacy and are now trying to get it from a retail pharmacy and community pharmacy.\u201d<\/p>\n Meanwhile, Lilly says tirzepatide is no longer in shortage. <\/p>\n In a statement issued Monday, Lilly spokesman Jared Shapiro<\/a> told NBC News<\/em> that all doses of Mounjaro and Zepbound are available, warning that it\u2019s important that patients \u201cnot be exposed to the risks in taking untested, unapproved knockoffs.\u201d<\/p>\n \u201cNothing changes the fact that, as FDA has recognized, Mounjaro and Zepbound are available and the shortage remains \u2018resolved,\u2019\u201d Shapiro added. <\/p>\n The FDA didn\u2019t respond to a request for comment on its reversal.<\/p>\n Meanwhile, Lee Rosebush, chairman of the Outsourcing Facilities Association, which filed the lawsuit, said in a statement<\/a> that it was \u201crelieved, for our members and the many patients that they serve.\u201d <\/p>\n \u201cWe believe that this is a fair resolution in light of the agency\u2019s rash decision to take the drug off the list at a time when the agency has acknowledged \u2018supply disruptions,\u2019\u201d Rosebush said. \u201cMost important, should the FDA repeat its removal decision when a shortage still genuinely exists, we will return to court.\u201d<\/p>\n More information<\/strong><\/p>\n Drugs.com has more on weight-loss drugs<\/a>.<\/p>\n SOURCE: U.S. District Court for the Northern District of Texas, court filing<\/a>, Oct. 7, 2024; NBC News<\/em><\/p>\n