A Compounder on a Black Market: Why Do Pharmaceutical Companies Need to Compound Their Products? A Case Study by Eli Lilly, a California Law Professor,
Welch says when his customers can’t get either brand-name or compounded products from him, he fears they will turn to what he called black market websites, which might have counterfeit products that could be harmful. “That is my biggest fear.”
Neither of them has a lawyer on staff. One has decided to keep compounding despite FDA’s suspension of enforcement as it reviews the shortage. The other has decided to use an outsourcing facility rather than compound its own on its own.
“So when companies file these types of actions, … it will make the agency gun shy in future circumstances,” she says. “So this sets up a dynamic in which companies on both sides, either compounders or pharmaceutical companies, can threaten to tie them up for a while.
Feldman says government agencies don’t want to be bogged down by lawsuits and other processes that keep them from doing their regular jobs. Agencies can not afford lawsuits and they are expensive.
While the battle over diabetes and weight-loss drugs is unprecedented, the drug companies aren’t exactly using a new playbook, says Feldman, the law professor at the University of California.
There is a problem. The FDA drug list they reference? It doesn’t exist yet. A proposed federal rule outlining how such a list would work hasn’t yet been finalized.
The FDA stated in an email that the comment period for the proposed rule ended on June 18, 2024. “The agency is in the process of reviewing comments for consideration in issuing a final rule.”
There are many examples of these risks provided by our nomination, and even instances where semaglutide was not present in the product. “The urgency of the situation necessitates immediate action.”
The shortage rule tells you why a compounding pharmacists can make copies of the key ingredients in Ozempic and Wegovy.
In the past four years, Eli Lilly has spent over $20 billion on manufacturing and this will allow them to continue bringing their medicines to people who need them.
Trade-offs between the FDA and compounding pharmacies: A voice-over in the case of the compounded Tiyrepatide
After the suit was filed, there was a re-evaluation by the agency and compounders would be allowed to continue their preparation.
“You’d think that would be a basic question because how do you know what the true market is if you haven’t even asked how big it is?” Rosebush says. If Eli Lilly were unable to supply the drugs for all the patients who were using name brand drugs, then they would have to switch to compounded versions.
There’s a reason compounders are not allowed to make “essentially a copy” of an existing FDA-approved drug.
“There’s limited allocations on everything,” he said, checking it in real time while on a Zoom call with NPR. “But they’re completely out of Zepbound, 15 milligram and 10 milligram, Mounjaro 10 milligram…There’s no allocation, zero availability to order any of it.”
They make drugs that are not generic and buy ingredients from FDA registered suppliers to create finished versions for patients with prescriptions specifically for compounded medicines.
She couldn’t. She could only get one box per day at that time. That meant she could only take care of 30 patients per month — and she had a lot more patients taking compounded tirzepatide than that.
The FDA was sued by a group of large-scale compounders, which questioned if the removal of Tiyrepatide from the shortage list was appropriate.
Compounding pharmacists are licensed to prepare custom drugs for people who need them. For example, they’ll make a liquid version of a brand name pill for a patient who can’t swallow pills.
Source: Drugmakers and pharmacists battle over who gets to make obesity drugs
Ozempic Pill Pills from Compounding Pharmacies and Telehealth Clinics: A Case Study of Loss and Obesity
As the battle over who gets what share of the multi-billion dollar obesity drug market continues, some patients are left wondering how they’re going to get their next injections — and from whom.
Ozempic and similar drugs for Type 2 diabetes and weight loss are in such high demand that the drugmakers have had a hard time keeping up. So compounding pharmacies stepped in to fill the gap, making their own versions of the drugs for more than two years.
Ozempic have been in high demand since they were introduced. In addition to treating diabetes and obesity, these medications have cardiovascular benefits, and there’s evidence they may curb addiction and possibly even protect against some types of cancer, which has only further broadened their appeal. For people who do not like needles, these medications have one big downside: you have to take a weekly shot.
The ads for oral knock-offs of GLP-1 drugs are available on platforms like Facebook. After the brand-name GLP-1 drugs went into shortage in 2022, a booming industry of “compounding” pharmacies and telehealth clinics arose to offer copies of the medications, as they are legally permitted to do when shortages exist. But unlike the pharma giants that produce the originals, these virtual clinics and specialty pharmacies are offering versions of semaglutide and tirzepatide for weight loss that are taken by mouth. They promise to deliver the same active ingredient as the trademark medications without the injections.
Since these drugs are less expensive than name-brand equivalents, and are often sent overnight after a prospective patient fills out a short online questionnaire, it is an appealing prospect. A month’s supply of semaglutide lozenges with vitamin B6 added from the telehealth startup Strut, for example, costs $149 without insurance, versus Wegovy’s $1,000-plus price tag.