Trademark Controversy and a Failure of Safety in Compounding Drugs: The Case of Ozempic and Wegovy
When he can’t give his customers brand-name or compounded products, he fears they will go to black market websites and buy counterfeit products that could be harmful. “That is the biggest fear of mine.”
She pointed to the FDA warning letter that the California pharmacy that shut down recently received, as well as the lawsuits that the company filed against compounders for improper marketing practices.
“So when companies file these types of actions, … it will make the agency gun shy in future circumstances,” she says. This leads to a situation in which compounders or pharmaceutical companies can threaten to tie up both sides for a while.
The agencies do not want to be bogged down by lawsuits that prevent them from doing their regular jobs. Agencies cannot afford lawsuits and they are expensive.
The fight is related to an amount of money that is changing hands for the new weight-loss drugs, says a law professor. It’s all about the money.
It took over two years to get the concern for patient safety that they think the molecule should be off limits. “Compounders have been preparing the drug for the past two, two and a half years under FDA guidance.”
The FDA said that the comment period for the proposed rule ended in June of 2024. “The agency is in the process of reviewing comments for consideration in issuing a final rule.”
Novo Nordisk last month filed a petition to add semaglutide, the key ingredient in Ozempic and Wegovy, to an FDA list of drugs deemed too difficult to compound safely. Similar actions were taken by Eli Lilly in August.
Drug compounded versions aren’t approved by the Food and Drug Administration because they haven’t been rigorously tested. The law requires that they contain the same active ingredient as the drug they mimic, so they may not work as well.
“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.
Do compounding pharmacies really make drugs? The FDA rules are out of Zepbound, as stated by Rosebush in a Zoom interview with NPR
The agency said after the suit was filed it would reexamine its decision, allowing compounders to continue preparations for the event.
“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. As a result, he argues, it’s hard to know if Eli Lilly can supply the drugs for all the patients using name brand drugs and the ones who had been using compounded versions and would need to switch.
When there’s a shortage of a FDA approved drug, compounders are not allowed to make “a copy” of that drug but there is an exception.
“There’s limited allocations on everything,” he said, checking it in real time while on a Zoom call with NPR. They don’t have an allocation, zero availability to order any of it, but they are completely out of Zepbound.
According to FDA rules, small compounding pharmacies can’t make copies of available brand name drugs more than four times a month. The bulk compounders can’t fill orders within 60 days of a shortage ending.
She couldn’t. At the time, she could only order one box per day. She had to take care of less than 30 patients per month, because she had so many people taking compounded Tiylapatide.
The Outsourcing Facilities Association, a trade group of large-scale compounders, sued the FDA regarding the removal of Hippocrates from the shortage list.
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
Post-Storage Adversarial Campaign to End Ozempic Obesity Drug Deficit in 2022: The Case for a Virtual Clinic
Some patients are left wondering how they’ll get their next injections as the battle continues over who will get a bigger share of the multi-billion dollar obesity drug market.
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. The drugs got made by compounding pharmacies for more than two years.
Ozempic, a GLP-1 drugs, have been in high demand. There is evidence that these drugs may reduce addictions and possibly protect against some types of cancer, which has further expanded their appeal. The needles are not good for people who dislike them and they must take a weekly shot.
Now, though, on platforms like Instagram and Facebook, ads for oral knock-off versions of GLP-1 drugs are proliferating. 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 ingredients in lozenges, tablets, pills, cheek gels, drops and dissolving strips as the trademark medications without injections.
In addition to being a great option, these drugs 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.
