If you’ve been living under a rock for the past few years, take note that there are very effective medications used to treat obesity and type II diabetes. They include products with glucagon-like peptide (GLP-1) activity.
The two dominant players in the industry are Novo Nordisk and Lilly.
Novo Nordisk distributes semaglutide: Ozempic for Type 2 diabetes; and Wegovy, a higher-dose product, approved for weight loss.
Lilly distributes tirzepatide: Mounjaro for Type 2 diabetes; and Zepbound, a higher-dose product, approved for weight loss. Tirzepatide works by mimicking two gut hormones: GLP-1 and glucose-dependent insulinotropic polypeptide (GIP).
Normally, when a drug is approved, the pharmaceutical sponsor has monopoly rights to distribute. The branded pharmaceuticals of Novo Nordisk and Lilly are not cheap. A one month supply is typically $1,000. Or more. And depending upon the patient’s insurance, it may not be covered.
Because of such high demand, patients HAVE been able to obtain what they want. Actually, it’s more accurate to say because of limited supply, patients HAVE been able to obtain what they want.
When drugs are in shortage, compounders are permitted to sell versions of those medications ostensibly to ensure patients can continue receiving care. By outsourcing to compounding pharmacies, companies and medical spas have been able to circumvent Eli Lilly and Novo Nordisk’s exclusive hold on GLP-1 drugs.
Many medications are currently on the FDA’s shortage list. As of October 2024, for example, clonazepam tablets and cis-platinum injections are in short supply. Most patients are not rushing to compounders to fill that need.
Presumably there’s a common manufacturing pathway for the compounded medications and branded medications.
Patients who have been accessing compounded GLP-1 drugs have been paying as low as $100/month.
This sets the stage for Novo Nordisk and Lilly to ramp up manufacturing capacity to serve anticipated demand.
On October 2, 2024, FDA sent out a press release.
The U.S. Food and Drug Administration has determined the shortage of tirzepatide injection, a glucagon-like peptide 1 (GLP-1) medication, has been resolved. Tirzepatide injection has been in shortage since 2022 due to increased demand.
FDA confirmed with the drug’s manufacturer that their stated product availability and manufacturing capacity can meet the present and projected national demand. Patients and prescribers may still see intermittent localized supply disruptions as the products move through the supply chain from the manufacturer and distributors to local pharmacies.
FDA reminds compounders of the legal restrictions on making copies of FDA-approved drugs
Compounded drugs are not approved by FDA. FDA-approved drugs go through FDA’s rigorous review for safety, effectiveness, and quality as part of the premarket approval process. Compounded drugs must meet conditions to qualify for exemptions under sections 503A and 503B of the Federal Food, Drug and Cosmetic (FD&C) Act. Among the conditions are:
- Section 503A of the FD&C Act includes restrictions on compounding drugs that are essentially copies of a commercially available drug. When a drug shortage is resolved, FDA generally considers the drug to be commercially available. Certain amounts are permissible under the law as long as the compounding is not done “regularly or in inordinate amounts.”
- Section 503B of the FD&C Act restricts outsourcing facilities from making compounded drugs that are essentially a copy of one or more FDA-approved drugs. Among other things, this means the compounded drug may not be identical or nearly identical to an FDA-approved drug unless the approved drug is on FDA’s drug shortage list.
Current shortage status of GLP-1 products (as of October 02, 2024):
- Tirzepatide injection: Shortage resolved.
- Dulaglutide injection: In shortage.
- Semaglutide injection: In shortage. Manufacturer has reported all but one of the presentations are available.
- Liraglutide injection: In shortage. Manufacturer has reported 2 presentations are available, and three have limited availability.
The agency will continue to work with manufacturers to help resolve the current shortages, and, as shortages resolve, will closely monitor the situation and provide any assistance we can to help manufacturers ensure an adequate supply. Before determining that a shortage is resolved, FDA considers a variety of factors, including the company’s ability to meet current and historical demand, the amount in a manufacturer’s stock, affected market share, ability of alternate manufacturers to cover the demand, and confirmed market stabilization. Please visit FDA’s Drug Shortages Database for the most recent information on the status of GLP-1 medicines and other drugs in shortage.
On first blush, it appeared the “party was over” for those seeking inexpensive compounded tirzepatide.
Semaglutide was still in short supply, and available via compounders at low price. But even that could change quickly.
Then, a lawsuit was filed in Fort Worth, Texas federal court by the Outsourcing Facilities Association claiming the FDA failed to follow proper procedures in making the change.
The FDA did not give the public a chance to weigh in on its decision and trusted assurances from Lilly, “the company that is self-interested in monopolizing the market,” that it could meet projected demand, the lawsuit said.
It called the FDA’s action “arbitrary, capricious and contrary to law.”
Then, the FDA agreed to reconsider its decision; staying the lawsuit.
The agency said in a court filing it would now allow compounding pharmacies and facilities to keep providing the drugs while it reviews whether there is a shortage of their active ingredient. Outsourcing Facilities Association Chairman Lee Rosebush said in a statement the group was “greatly relieved, for our members and the many patients that they serve, that the FDA has agreed to reconsider its decision.”
The Outsourcing Facilities Association claimed in its lawsuit the FDA removed tirzepatide from its shortage list even though it remained in short supply.
Lilly in August began sending cease-and-desist letters to telehealth companies, wellness centers and medical spas selling compounded versions of Zepbound and Mounjaro. The company has also filed lawsuits against sellers falsely claiming to sell FDA-approved versions of the drug.
Is there a shortage of tirzepatide? Dunno. How is current supply/demand calculated? How is projected supply/demand calculated? Given the number of drugs on the shortage list, one would think that there are standard metrics for making such conclusions. But perhaps it’s a judgment call, and there’s flexibility.
So, what’s next?
I think the GLP-1 compounding party will soon be over. But I think other options will open up.
There will be tremendous pressure for the pharmaceutical companies to lower their prices. The drug does not cost much to manufacture, and they can still make their top line revenue numbers, and continue to make a fortune.
New competitors will be coming on line soon, putting more price pressure on established players.
Next carriers will be under pressure. Carriers can also push for price concessions from pharma. Given the health benefits, carriers should be motivated. Because they’re on the hook for costs associated with obesity and diabetes.
There may be options for individual patients to import from Canada or other countries.
And Congress can act. Or can it?
Anyway, the country got used to low cost GLP-1 medications, and given that such medications are intended for chronic use, it’s hard to see how the country will make nice and go back to accepting expensive medications with the supply constrained by limited insurance coverage. The US is a noisy country. And this issue may get a lot more attention than some of the other political issues in the news.
What do you think?
It just seems like there is a very cozy relationship between pharmaceutical companies and the FDA to promote expensive drugs and put inexpensive drugs out of reach.
Example the generic drug droperidol used as an anti nausea drug, was given a black box warning, shortly after a much more expensive drug came on the market. Droperidol was reviewed in an article at the time in the Anesthesia Patient Safety Foundation newsletter, and found to have a long history of safety. The article presenting indications that the information submitted to the FDA that caused the drug to get a black box warning were dubious. Nevertheless, the drug is difficult to come by, and hospital pharmacists are reluctant to carry it due to the black box warning.
More recently, inexpensive generic drugs with decent clinical evidence of efficacy, in treating covid, were made unavailable, while expensive branded drugs were approved by the FDA.
Will a revamp of the FDA solve these industry influence problems? Only time will tell.