I Asked The FDA How They Plan to Deal with Compounded Tirzepatide
Their response was unsurprisngly vague
Just yesterday, the FDA changed the official status of tirzepatide, sold by Eli Lilly as Mounjaro for diabetes or Zepbound for weight loss, from “in shortage” to “resolved.”
Because tirzepatide remained on the FDA's shortage list for two years, vials of compounded tirzepatide have become an increasingly popular alternative to paying the astronomical prices of Eli Lilly’s branded injection pens. Per the FDA, compounding pharmacies aren't allowed to produce identical copies of brand-name medications unless certain criteria are met. The key criteria for tirzepatide was its place on the FDA shortage list.
A resolved shortage means “the FDA confirmed with the drug’s manufacturer that their stated product availability and manufacturing capacity can meet the present and projected national demand.” Many patients taking tirzepatide, branded or compounded, find it very hard to believe that Eli Lilly can genuinely meet the present or projected demand for Zepbound and Mounjaro. Some of us suspect the manufacturer placed significant pressure upon the agency, which has frankly faced its share of scandals and criticism for putting money over patients for decades.
Now that the tirzepatide shortage categorized as resolved, however, it's got plenty of patients like me, who've come to rely upon compounded tirzepatide, feeling very nervous about what happens next.
I've already asked multiple pharmacy owners how they think the news will affect us. I've also reached out to my PCP/prescriber and current compounding pharmacy to hear their thoughts. For the most part, folks aren't ready to give up without a fight.
Of course, Eli Lilly is much more litigious than other manufacturers, including Novo Nordisk, who manufactures Wegovy and Ozempic.
With that in mind, I decided to ask the FDA to respond to that panic. They've got an email address dedicated to questions from the media with a set form letter, so I filled it out and was surprised to receive a reply in about an hour.
Here's what I asked, knowing that while they do not directly control access or pricing, it would be interesting to hear what they have to say… or what they would not say.
“Since the FDA recently marked the Tirzepatide shortage as "resolved," many patients are panicking about how they will be able to fill and afford their much-needed prescriptions.”
“How does the FDA plan to deal with compounded tirzepatide?”
“What guidance can the FDA give patients who depend upon compounded tirzepatide as an affordable and accessible alternative to Eli Lilly’s Mounjaro or Zepbound?”
“Many patients are stuck with health insurance plans that specifically exclude tirzepatide from their formulary, and even with the manufacturer's savings card, $650 every four weeks is more than most Americans can afford. Meanwhile, other countries around the world can buy the same medication for a fraction of the price. Any observations or guidance from the FDA would be greatly appreciated.”
And here's how the FDA replied,
“To ensure we are on the same page about what information we can provide you, please note that the FDA does not regulate the practice of medicine and we encourage patients to speak with their health care provider if they have concerns about obtaining a prescription drug. Please also note that drug pricing is not within the FDA’s regulatory purview, so we cannot comment on that.”
“Please see some below information about compounding, and please note that 503A and 503B are different:”
“The FDA’s compounding program aims to protect patients from unsafe, ineffective, and poor-quality compounded drugs, while preserving access to lawfully marketed compounded drugs for patients who have a medical need for them. Although compounded drugs can serve an important medical need for certain patients, they also present a risk because compounded drug products are not FDA-approved. This means they have not undergone FDA premarket review for safety, effectiveness, and quality.”
“Federal law addresses compounding by a licensed pharmacist in a state-licensed pharmacy, federal facility, or by a physician (503A), as well as compounding by or under the direct supervision of a licensed pharmacist in an outsourcing facility (503B). A drug may be compounded for a patient when an FDA approved drug is not medically appropriate to treat them. Generally, when an FDA approved drug is in shortage, compounders may prepare a compounded form it if they meet certain requirements in the Federal Food, Drug, and Cosmetic (FD&C) Act.”
“Section 503A of the FD&C Act restricts compounded drugs that are essentially copies of commercially available, but certain amounts are permissible under the law as long as the compounding is not done "regularly or in inordinate amounts." All other conditions of section 503A would have to be met, including compounding pursuant to a valid prescription for an identified patient.”
“Outsourcing facilities operating under section 503B of the FD&C Act are generally prohibited from making essentially a copy of an FDA approved drug. However, this limitation is lifted in certain instances, such as when an FDA-approved drug appears on the FDA Drug Shortage list. The FDA recognizes that there may be circumstances where an outsourcing facility may not be able to predict when a drug shortage will be resolved, and the facility may have orders for a compounded drug in-house that were in progress when the drug was removed from FDA’s drug shortage list.”
“FDA policy provides some regulatory flexibility when an outsourcing facility fills orders that it received for a compounded drug while the drug was in shortage. The FDA may take regulatory action, however, if an outsourcing facility continues to fill new orders for the compounded drug after the approved drug is removed from FDA’s drug shortage list, or if it continues to fill orders more than 60 days after the drug has been removed from FDA’s drug shortage list.”
“Generally, we recommend patients use the FDA approved drug when available. An FDA approved drug may continue to be compounded for a patient when an FDA approved drug is not medically appropriate to treat them, regardless of whether the FDA approved version of the drug is in shortage or not. In these situations, such as a patient who has an allergy to a certain dye and needs a medication to be made without it, or an elderly patient or a child who cannot swallow a tablet or capsule and needs a medicine in a liquid dosage form, compounding can serve an important patient need.”
Honestly, all of that information is readily available online, so they really didn't tell me anything new. Yet, that's possibly the greatest silver lining in all of this.
They could have explicitly stated that the compounding of tirzepatide must end, or that patients will now need to seek out the brand name(s) from their prescribers and Eli Lilly. But they didn't. Instead, they were largely vague on details as to how and when they might get involved to officially END compounded tirzepatide.
Even the fact that they said they “generally recommend patients use the FDA approved” drug (in this case, the brand), gives me a bit of hope to continue to use the compound.
It may work out to get a prescription for unique doses that Eli Lilly currently doesn't offer, to allow me to titrate up to the maximum dose more slowly. It's generally believed that patients like myself with more weight to lose and more underlying issues like lipedema and PCOS will eventually require the maximum dose, but there's also concern about getting there “too fast” before we've lost all of the weight we need to lose.
It's possible that unique doses may help some of us in getting our medication from a 503A compounding pharmacy. Other ideas floating around are the inclusive of certain ingredients to assist in muscle retention or to help alleviate certain side effects.
However it turns out, I am going to take it week by week, refill by refill. It will be interesting to see what happens, but I doubt it will be as simple as the end of compounded tirzepatide.