(The Hill) - Federal regulators shook up the booming weight loss drug marketplace when they announced Mounjaro and Zepbound to be no longer in shortage after nearly two years.
Pharmacies that sold unbranded copies of those drugs are mounting a coordinated effort to reverse this decision, as another fight over the wildly popular drugs Ozempic and Wegovy looms.
Mounjaro and Zepbound are both names for the drug tirzepatide, the diabetes and obesity medication made by the multinational pharmaceutical giant Eli Lilly. It falls in the same class of drugs as Ozempic and Wegovy, all of them being GLP-1 agonists.
Tirzepatide was first approved by the Food and Drug Administration (FDA) in 2022 and has no generic versions on the market. But when the drug was declared to be in shortage in December that same year due to skyrocketing demand, compounding pharmacies were able to sell unbranded versions with the same active ingredient for significantly less than the original.
That all came to an end on Oct. 2, when the FDA confirmed Eli Lilly’s “manufacturing capacity can meet the present and projected national demand.”
When drugs are in shortage, compounders are permitted to sell versions of those medications ostensibly to ensure patients can continue receiving care. By outsourcing to compounding pharmacies, companies and medical spas have been able to circumvent Eli Lilly’s and Novo Nordisk’s exclusive hold on GLP-1 drugs.
Both Ozempic and Wegovy remain on the FDA’s shortage list, but compounders are already concerned for when that ends too.
In the week since the shortage was declared over, compounding pharmacies have launched an intense campaign in protest, one trade group has already filed a lawsuit to try and reverse the decision.
The Outsourcing Facilities Association (OFA), which represents 503B compounding pharmacies, alleged in its lawsuit against the FDA that the shortage persists and that the end of the shortage was “abruptly depriving patients of much needed treatment.”
“Put simply, FDA knows its action will leave many patients with no effective treatment but persisted with that action anyway on an expedited basis and without warning,” the organization said in its suit.
Compounding pharmacies produce individualized forms of drugs for patients who are unable to take FDA-approved versions, in some cases because they can’t consume solids or they’re allergic to a component of the drug.
There are two types of compounding pharmacies: 503A and 503B. 503As fulfill patient-specific prescriptions while 503Bs can do the same while also fulfilling bulk orders for healthcare providers like hospitals.
Telehealth companies like Hims & Hers and Noom have utilized the latter to fulfill online orders of compounded tirzepatide as well as semaglutide, the active ingredient in Ozempic and Wegovy. While these pharmacies are FDA-regulated, the products they produce are not.
Hims outright bought its own 503B compounding pharmacy earlier this year, a sign of the tech world’s plans to sell compounded drugs well into the future.
The new venture has been profitable, even at the reduced rates that Hims is selling semaglutide for (starting at $200 a month compared to nearly $1,000 a month for Ozempic). As one Yale University-led study found, a month’s supply of semaglutide could be profitably produced for less than $5.
“The launch of GLP-1 injections has significantly contributed to our growth, driving a 6-point acceleration in year-over-year consolidated revenue growth to 52%,” a Hims & Hers spokesperson said in a statement.
The outsourcing pharmacies are asking that the FDA’s removal of tirzepatide from the shortage list be declared a violation of the Administrative Procedure Act and that the agency be permanently blocked from going after 503B pharmacies for compounding tirzepatide.
Scott Brunner, CEO of the Alliance for Pharmacy Compounding, said in a press briefing that “a lot of patients have been left flat footed” by the end of the shortage.
“Patients taking compounded tirzepatide injection are going to need to be transitioned to the FDA-approved drug Mounjaro or Zepbound,” Brunner said. “In many instances, it's going to take some time. They've got to get in to see their prescriber, they need to have a discussion with the prescriber about whether the FDA-approved drug is indeed the right medication for them.”
The FDA’s guidance for 503B compounding pharmacies does include rules for transitioning patients from compounded drugs to the branded versions. The guidance explicitly states the agency "does not intend” to go after companies fulfilling orders for compounded drugs that were received when the shortage was still in effect. These compounded drugs must be distributed or dispensed within 60 days of when the branded drug was last on the shortage list.
For physicians like Angela Fitch, co-founder and chief medical officer of the metabolic care startup knownwell, the end of the tirzepatide shortage is a mixed bag. While acknowledging the more affordable prices and expanded access, Fitch has concerns over how these products are sourced.
“We want more people to get access to care, and that's the biggest thing we're trying to drive,” said Fitch, noting however that “we cannot guarantee the safety and efficacy from the supply chain standpoint.”
The FDA made it clear in its announcement that a “compounded drug may not be identical or nearly identical to an FDA-approved drug unless the approved drug is on FDA’s drug shortage list.”
Some telehealth companies that sold compounded tirzepatide, such as Eden, have since ceased selling it. After a request for comment by The Hill, a representative from Eden appeared to confuse the reporter for a patient, and suggested transitioning to compounded semaglutide which the company also sells.
Compounding pharmacies argue that fewer patients will have access to these drugs with the shortage ending, as the higher cost of the branded version may be financially prohibitive for many who were taking the compounded version.
Lilly recently announced plans to sell cheaper, single-dose vials of Zepbound.
Fitch noted that many patients are often unaware that their insurance will cover GLP-1 medications. But she also emphasized that GLP-1 medications like Mounjaro are Ozempic are not the only options when it comes to weight loss or diabetes, and signficantly more affordable FDA-approved options do exist.
Eli Lilly has commenced its own legal action against compounders in the wake of the FDA’s determination, sending out hundreds of cease-and-desist letters to pharmacies, medical spas and clinics.
A spokesperson for Eli Lilly said in the statement to The Hill the company was taking steps to “help address the patient safety risks posed by the proliferation of counterfeit, fake, and unsafe or untested compounded tirzepatide.”
“Our efforts alone are not sufficient—we continue to call upon state and federal regulators and law enforcement to take action against those who put people at risk by manufacturing, marketing, or selling unapproved knockoffs of Lilly’s genuine, FDA-approved medicines,” said the Lilly spokesperson.
