Originally published by our sister publication Specialty Pharmacy Continuum
By Bruce Buckley
Dozens of unscrupulous web-based sellers of glucagon-like peptide-1 agonist drugs are evading FDA scrutiny and patient safety controls to hawk GLP-1 weight-loss drugs outside of the legitimate prescription drug supply chain, according to a new research-based editorial in Annals of Pharmacotherapy.
The paper, by pharmacist-researchers from the University of Connecticut School of Pharmacy in Storrs, identifies at least 40 sites that market vials of lyophilized semaglutide and tirzepatide powder to customers without prescriptions. Nearly all of the sites list the GLP-1 products as “for research purposes only” and “not for human consumption,” a ploy, the authors maintain, that is intended to dodge federal and state consumer protection laws. Only four of the sites ask buyers to identify themselves as researchers (Ann Pharmacother 2024 Sep 17. doi:10.1177/10600280241277551).
Missing from these sites, the authors say, are any prescriber or pharmacist instructions on how to properly draw up the drugs and safely inject appropriate doses. “Patients are effectively on their own,” they add, when it comes to maintaining drug sterility and avoiding overdoses.
C. Michael White, PharmD, a distinguished professor at the UConn School of Pharmacy, and an author of the editorial, noted that “prescribers have a responsibility to write prescriptions for the right patients, and that is being circumvented by this new shadow system.” Moreover, he said, these online sites eliminate the pharmacist’s “final check” for detecting dosing errors and drug interactions.
Since the start of GLP-1 shortages in 2022, people have been drawn to these illegitimate peptide-selling sites by the prospect of obtaining the popular obesity drugs without prescriptions at deeply discounted prices. The study notes, for example, that a brand-name GLP-1 medication for weight loss or glucose control can cost an average of $800 to $1,000 per month. The illicit sites, in contrast, charge an average of $181 for semaglutide and $203 for tirzepatide.
In August, the tirzepatide shortage ended after Eli Lilly announced the release of its weight-loss drug Zepbound (tirzepatide) in 2.5- and 5-mg single-dose vials, via its LillyDirect channel. Adults with obesity who have a valid electronic prescription can now obtain the drug by mail at a price, the company said, at least half of that charged for other brand-name GLP-1 products. (The FDA has since announced that it is reconsidering its decision to remove tirzepatide from its shortages list and would halt most enforcement actions until two weeks after it had made a new determination following a lawsuit brought by the Outsourcing Facilities Association, asserting that shortages continue to exist.)
Dr. White noted that Eli Lilly was able to “dramatically boost” tirzepatide production by eliminating the manufacturing step required to put the drug into an injectable pen. However, he added that he was concerned that Lilly’s use of its in-house pharmacy to distribute the drug risked “cutting out the community pharmacy piece.”
He is also concerned that with tirzepatide no longer in shortage, “the pharmacies that were selling compounded tirzepatide are going to be pushed out of the marketplace,” adding that people who want lower-cost product will have to spend more for the branded drug or “start trying this other [illegal] peptide pathway.”
Asked to comment, Eli Lilly noed that “distributing Zepbound single-dose vials through LillyDirect’s self-pay channel allows us to offer transparent pricing, cut out extra costs, and pass savings directly to patients. Through this exclusive distribution channel, Lilly can also ensure patients receive genuine Lilly medicine and help patients avoid the risks posed by counterfeit and unsafe or untested knockoffs of Lilly’s FDA-approved medicines.”
Dr. White said pharmacists and pharmacy organizations can help counter illicit GLP-1 sales by pressuring the FDA to increase its surveillance and regulation of these sites as well as stiffen inspections of foreign manufacturers that supply the active pharmaceutical ingredients that enable these illegal sites to exist.
In October, Dr. White issued a “buyer beware” press release describing the dangers that consumers face in obtaining off-brand Ozempic (semaglutide) and other weight-loss drugs without a prescription. Now, he told Specialty Pharmacy Continuum, “we’re going to send the list of sites we’ve uncovered to the FDA and Federal Trade Commission showing how these sites are scamming the system to sell these GLP-1 drugs that are supposed to be for research purposes only and not for human consumption.”
Michael J. Gaunt, PharmD, a senior manager of error reporting programs at the Institute for Safe Medication Practices, said the UConn study provided “one more example of risks patients face as they may not fully understand the potential harm when they get drug products of dubious quality without prescriptions” from online sites and elsewhere that lack regulatory oversight. This is the kind of information, he added, that needs to be shared by pharmacy and medical professionals and that stimulates “conversations with patients” about the potential risks.
The Website That Triggered the UConn Study
As for how Dr. White discovered these illicit GLP-1 sites, he noted that he was searching the web after learning that NBC and CNBC were planning a report on glucagon-like peptide-1 (GLP-1) compounding pharmacies when he was startled to come across a site—which was not a compounding pharmacy—displaying a semaglutide bottle marked “not for human assumption” in very small print.
“In my mind,” he told Specialty Pharmacy Continuum, “this hearkened back to the vulnerability in our healthcare system” that for years allowed “synthetic cathinones to be sold in the United States as bath salts. And the people selling them and those buying them knew they were not intended for baths, but were synthetic stimulants meant to give a cocaine- or methamphetamine-like jolt.”
Dr. White wondered: Did this GLP-1 seller represent an isolated case or was it symptomatic of a wider issue? So he enlisted UConn pharmacy students in a wide-ranging search that led to the discovery at least 40 sites employing a similar shady business model.
Drs. Gaunt and White reported no relevant financial disclosures.
