There is a lot of off-brand oral ozompic for sale online
Why is Eli Lilly in the News? The Coalition of Pharmacy Compounding Practitioners Against Lilly’s Sufficient Requirements
When his customers can’t get either brand name or compounded products from him, he believes they will turn to black market websites which may have fake products that could be harmful. “That is my biggest fear.”
NPR spoke with the compounding pharmacists in North Carolina and Virginia, who both said that they had received cease and tetanus letters from Eli Lilly before the shortage ended.
“When companies file these actions, they make the agency gun shy in future circumstances,” she says. This puts a situation in which compoundsers or pharmaceutical companies can threat to tie the other 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 are not able to afford the cost of lawsuits.
What’s underlying the fight, says Robin Feldman, a law professor at the University of California, is “the inordinate amount of money that is changing hands for the new weight-loss drugs, their incredible efficacy, the runaway demand. It’s all about the dollars.”
“Everybody knows that… [the] injections are going to come off the shortage list eventually and patients need to be prepared for that,” says Scott Brunner, the CEO of the Alliance for Pharmacy Compounding, the industry trade group. “Compounded copies of these FDA-approved drugs are not a long-term therapy for these patients.”
“The comment period for the proposed rule closed on June 18, 2024,” an FDA spokesperson wrote in an email to NPR. The agency is in the middle of a process of taking comments.
“Our nomination provides numerous examples of these risks, including unknown impurities, peptide-related impurities, incorrect strengths, and even instances where no semaglutide was present in the product at all,” Novo Nordisk spokesperson Jamie Bennet wrote in an email to NPR. “The urgency of the situation necessitates immediate action.”
The shortage rule tells you why compounding pharmacists are able to make copies of the key ingredients in Ozempic and Wegovy.
“Our current manufacturing investment of over $20 billion in the past four years is the most significant in our history, and will allow us to continue increasing capacity to safely bring these medicines to people who need them,” Eli Lilly spokesperson Courtney Kasinger wrote in an email.
On the FDA’s decision to ban compounding tirzepatide from the shortage list: A comment on Rosebush’s ozempic case
A few days after the suit was filed, the agency said it would re-evaluate its decision, allowing compounders to continue preparing tirzepatide in the meantime.
“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. He contends that it’s hard to know if Eli Lilly can make the drugs for all the patients who use name brand drugs or the ones who have been using compounded versions.
Under the law, compounders are not allowed to prepare “essentially a copy” of an existing FDA-approved drug, but there’s an exception when that drug is in short supply.
“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.”
According to FDA rules, small compounding pharmacies can’t make copies of available brand name drugs more than four times a month. And bulk compounders, called outsourcing facilities, can’t fill orders starting 60 days after a shortage ends.
Only she couldn’t. At the time, she could only order one box per day. That meant she could only take care of 30 patients per month — and she had a lot more patients taking compounded tirzepatide than that.
On Oct. 7, the Outsourcing Facilities Association, a trade group of large-scale compounders, sued the FDA, questioning whether the removal of tirzepatide from the shortage list was appropriate.
For people who need drugs, compounding pharmacists are licensed to prepare them. They will make a liquid version of a brand name pill for a patient who can’t swallow it.
Source: Drugmakers and pharmacists battle over who gets to make obesity drugs
Odontomic GLP-1 Drugs for Type 2 Diabetes and Weight Loss in a Multi-billion Dollar Market: The Case of Ozempic
Some patients are not sure who will give them their next injections as the battle over who gets what share of the multi-billion dollar obesity drug market continues.
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.
Since they debuted, injectable GLP-1 drugs like Ozempic have been in high demand. 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. The medications are not good for people who don’t like needles, and they require weekly shots.
There is no need to take oral GLP-1 medications if you are not obese according to Maria Daniela Hurtado a specialist at the MAYO Clinic in Jacksonville. “I do not consider them, I do not prescribe them, and I do not endorse them,” she says.
It’s an appealing prospect—especially since these drugs are offered at a fraction of the price of their name-brand counterparts and are often shipped overnight after a prospective patient fills out a quick online questionnaire. 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.
Several US compounding pharmacists said that they had received cease and tetanus letters from drugmaker Eli Lilly before the shortage of its anti-obesity drugs Ozempic and WeGovy ended. “Compounding copies of these FDA-approved drugs are not a long-term therapy for these patients,” Scott Brunner, the CEO of the Alliance for Pharmacy Compounding, the industry trade group, said.