Final month, the U.S. Meals and Drug Administration (the “FDA”) introduced in a Declaratory Order the decision of the scarcity of semaglutide injection merchandise Wegovy and Ozempic (the “February Declaratory Order”). On March 10th, the FDA issued steering clarifying that 503A and 503B drug compounders should quickly stop compounding semaglutide injection merchandise[i] or danger enforcement motion.[ii] This has a major influence on compounding pharmacies as, beneath the Federal Meals, Drug, and Beauty Act (the “FD&C”), drug compounders are permitted to compound their very own copies of a patented drug if the FDA determines it’s in scarcity. Attributable to excessive demand for the medication, Wegovy was added to the FDA’s drug scarcity listing in March 2022, and Ozempic in August 2022.[iii] Wegovy and Ozempic are the one FDA-approved semaglutide injection merchandise.[iv]
Authorized Challenges and Sensible Impacts of the FDA’s Declaratory Order
After the February Declaratory Order was issued, the Outsourcing Amenities Affiliation (the “OFA”) promptly filed a lawsuit towards the FDA over its determination and a movement for a preliminary injunction to stop the FDA from eradicating semaglutide from the drug scarcity listing.[v] U.S. District Courtroom Decide Mark Pittman, who’s listening to the case in a federal courtroom in Texas, accepted Novo Nordisk’s renewed movement to intervene within the case to help its declare that the corporate can meet the excessive demand for its merchandise.[vi]
In gentle of the OFA’s lawsuit, the FDA issued clarifying steering on when compounders should stop compounding semaglutide. For compounders which have relied on the drug scarcity to compound semaglutide, the FDA indicated that it’s going to delay any enforcement motion till the next dates, with a purpose to keep away from pointless disruption to affected person therapy:
- For state-licensed pharmacists or physicians compounding beneath Part 503A of the FD&C: April 22, 2025, or till the District Courtroom points a call on the OFA’s preliminary injunction movement, whichever is later; and
- For outsourcing amenities compounding beneath Part 503B of the FD&C: Could 22, 2025, or till the District Courtroom points a call on the OFA’s preliminary injunction movement, whichever is later.
The FDA famous that this delay in enforcement will permit sufferers an inexpensive period of time to switch their prescriptions to totally different pharmacies to acquire the FDA-approved drug in addition to to permit native pharmacies to regulate their stocking and ordering patterns to account for shifts in affected person demand.
Bases for the FDA’s Choice
The FDA is required to “preserve an up-to-date listing of medication which are decided by [the FDA] to be in scarcity in america”[vii] with a “scarcity” being “a time period when the demand or projected demand for the drug throughout the United Sates exceeds the availability of the drug.”[viii] To achieve its determination, the FDA famous its consideration of knowledge from quite a few stakeholders, together with people, telehealth corporations, pharmacy compounders, associations representing pharmacy compounders, outsourcing amenities, and Novo Nordisk, the producer of Wegovy and Ozempic. Novo Nordisk offered the FDA with info associated to its manufacturing and stock of the medication, together with portions provided and demanded, projected provide and demand in future months, and wholesaler stock knowledge. The FDA concluded that Novo Nordisk efficiently demonstrated that its provide presently meets or exceeds the demand for its semaglutide injection merchandise, and Novo Nordisk has developed adequate reserves such that provide will meet or exceed projected future calls for. The choice memorandum “Decision of Semaglutide Injection Product Scarcity and Provide Standing”, dated February 21, 2025, units forth the FDA’s full authorized evaluation upon which the February Declaratory Order relies.[ix]
The FDA acknowledged that it has obtained studies that some sufferers and pharmacists aren’t capable of get hold of the semaglutide injection merchandise via the conventional provide chain. Nonetheless, the FDA reasoned these cases of inaccessibility are probably brought on “by the sensible dynamics of the a part of the availability chain between Novo Nordisk and [its] clients, together with wholesale distributors and pharmacies” quite than by a nationwide scarcity of provide.[x]
What’s Subsequent for Compounders of Semaglutide?
Whereas the OFA’s lawsuit and request for a preliminary injunction has but to be determined, current comparable lawsuits inform the possible consequence. Particularly, the OFA beforehand filed a lawsuit towards the FDA in October concerning the removing of tirzepatide from the scarcity listing. The OFA’s October swimsuit delayed enforcement for a number of months whereas the FDA reconsidered its determination, however on March 5th, the courtroom upheld the FDA’s dedication that the tirzepatide scarcity had ended.[xi] Whereas it’s doable that the OFA’s swimsuit difficult the February Declaratory Order might finish in another way, it’s prone to have an identical consequence because the OFA’s problem of tirzepatide’s removing from the scarcity listing. That’s, enforcement could also be delayed barely, however the FDA will probably affirm its declaration that the semaglutide scarcity is over.
It’s anticipated that some compounding pharmacies, regardless of the February Declaratory Order, could proceed to compound modified variations, akin to in various doses or by including extra components, taking the place that it’s totally different than the patented variations of semaglutide. Nonetheless, it is a advanced space of regulation presently being litigated with respect to tirzepatide. As well as, drug producers have been actively issuing stop and desist letters and submitting lawsuits towards compounding pharmacies that produce tirzepatide. It’s cheap compounders of semaglutide shall be met with comparable motion in the event that they proceed to compound modified variations of semaglutide after April 22nd or Could 22nd, as relevant. As such, any compounding of medication not on the scarcity listing, together with semaglutide injection merchandise, ought to be approached with warning given the present authorized and regulatory panorama.
FOOTNOTES
[i] Rybelsus (semaglutide) tablets are FDA-approved for oral use and weren’t in scarcity. The FDA’s February Declaratory order particularly addresses the compounding of semaglutide injection merchandise which are “basically a replica of a commercially out there drug product” on the premise of the drug scarcity exception.
[ii] U.S. Meals and Drug Administration, Declaratory Order: Decision of Shortages of Semaglutide Injection Merchandise (Ozempic and Wegovy) (Feb. 21, 2025) [hereinafter “February Declaratory Order”].
[iii] February Declaratory Order, web page 1.
[iv] February Declaratory Order, web page 4.
[v] Outsourcing Amenities Ass’n v. United States Meals & Drug Admin., 4:25-cv-174 (N.D. Tex. Feb. 24, 2025).
[vi] Kevin Dunleavy, In FDA weight problems drug battle with compounders, Texas courtroom permits Novo Nordisk to weigh in, Fierce Pharma (Mar. 6, 2025, 8:45 AM).e
[vii] February Declaratory Order, web page 3 (citing Federal Meals, Drug, and Beauty Act § 506E(a)).
[viii] February Declaratory Order, web page 3 (citing Federal Meals, Drug, and Beauty Act § 506C(h)(2); 21 C.F.R. 314.81(b)(3)(iii)(f)).
[ix] February Declaratory Order, web page 1.
[x] February Declaratory Order, web page 2.
[xi] Outsourcing Amenities Ass’n v. United States Meals & Drug Admin., 4:24-cv-0953-P (N.D. Tex. Mar. 5, 2025).