Drugmakers and distributors fight over who gets to make the drugs that help people lose weight
The FDA’s fight against compounded drugs: An educator’s frustration at the lack of consistency in a pharmacist’s website dealing with brand-name drugs
If his customers can’t get brand-name or compounded products from him, he fears they’ll end up on black market websites, which could pose a threat to their health. “That is my greatest fear.”
A regular retail pharmacy and a small compounding pharmacy can be found 15 miles apart in Durham, N.C. She tried to order more of the drugs assuming patients would switch to name- Brand versions of the drugs after the shortages ended.
“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.
The government agencies do not want to bebogged down in lawsuits and other processes that prevent them from doing their jobs. Agencies can’t afford lawsuits and they are expensive.
The battle over Diabetes and Weight- Loss Drugs is unprecedented, but the drug companies aren’t exactly using a new template according to the law professor.
Brunner, who heads the compounding pharmacy trade group, said it took over two years for patients to be reassured about the safety of the molecule. “Compounders have been preparing the drug for the past two, two and a half years under FDA guidance.”
“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 process of reviewing comments for consideration in issuing a final rule.”
“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,” Jamie Bennet wrote in an email to NPR. The situation is urgent and needs immediate action.
Unlike the brand-name drugs Ozempic, Wegovy, Mounjaro, and Zepbound, compounded versions haven’t been rigorously tested in clinical trials, and they’re not approved by the Food and Drug Administration. And although by law they must contain the same active ingredient as the drug they mimic, these orally formulated medications may not work nearly as well as the injectable drugs.
Eli Lilly has invested more than $20billion in manufacturing in the last four years and will allow it to continue bringing medicine to people who need it, a company spokeswoman wrote in an email.
How big is the market of ozempic-semaglutide-tirzepatide-compounding-pharmacies? A call with NPR
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.
If you haven’t even asked how big the market is, how do you know what it is? 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.
compounders are not allowed to prepare a copy of an FDA approved drug, but there is an exception when the drug is in short supply.
“There’s limited allocations on everything” he said on a call with NPR while checking in real time. There is no allocation, zero availability to order any of it.
Drugs they make aren’t generics — rather they buy ingredients from Food and Drug Administration-registered suppliers and prepare finished versions for patients with prescriptions specifically for compounded medicines.
Only she couldn’t. At the time, she could only order one box per day. She could only care for 30 people per month and she had more patients 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.
Custom drugs are prepared 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 versus Wegovy: How much is it worth? The pharmacist questioning the efficacy of oral medications for Type 2 diabetes and weight loss
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. The gap was filled by compounding pharmacies who created their own versions of the drugs for over two years.
Ozempic has 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. But for people who hate needles, these medications hold a glaring, obvious drawback: They require taking a weekly shot.
“As a pharmacist, I can appreciate the excitement in the rise in oral semaglutide, since it is an easier route than injectables,” says Melinda Lee, a pharmacist who runs the pharmaceutical packaging company Parcel Health as well as a GLP-1 drug availability database. Oral versions also don’t need to be refrigerated like injectables, which makes them easier to ship and store. But although she understands the enthusiasm, Lee remains skeptical. She says that the evidence doesn’t show GLP-1s are as effective as they could be.
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. The cost of a month’s supply of semaglutide lozenges with vitamins B6 and calcium is just $150 without insurance, versus the $1,000 price tag of Wegovy.