Pharma Source Direct

Yesterday, Novo Nordisk asked FDA to add semaglutide to the demonstrably difficult to compound list. Here's our statement in response: Let me get this straight: So Novo Nordisk is apparently so deeply concerned about patient safety that it’s taken them a whopping two-and-a-half years while their drug has been in shortage to conclude that the semaglutide API is so demonstrably difficult for compounding pharmacies to prepare that FDA now needs to place it off-limits for compounding? To me, this looks more like desperation and an attempt by Novo to protect its revenue stream than a serious scientific argument. Some observations: ? Novo seems to be confusing the fact that the semaglutide molecule is demonstrably difficult to manufacture – indeed it is – with the relative simplicity of compounding with it. ? Novo asserts that because it uses recombinant active pharmaceutical ingredient in its FDA-approved GLP1s – instead of the synthetic API* that most compounders use – its API is somehow superior. While it is true that synthetic manufacturing of peptide API may result in more impurities in the drug, the testing labs we’ve talked with all indicate that those impurities are below 1%, well within acceptable industry ranges. And in terms of the clinical efficacy of the FDA-approved versus the compounded versions of semaglutide injection, there’s generally not a dime’s worth of difference. This is from FDA on that topic: https://lnkd.in/gRM3b--Z So, the FDA says you can demonstrate that they are the "same," and generics don't have to be recombinantly made to be the "same." ? In terms of reported adverse events, those reported to FDA’s FAERS database by patients taking the compounded version of semaglutide injection are remarkably similar to those reported by patients taking the FDA-approved version. This is further indication that the compounded and FDA-approved versions act in a patient’s body in the same way. Look, when in the judgment of a prescriber an FDA-approved drug is appropriate for a patient and that FDA-approved drug is available for dispensing to a patient, the FDA-approved drug is always the one that should be prescribed and dispensed. But we continue to be in a prolonged era in which the finished-form FDA-approved semaglutide injection products are not available. Novo’s ridiculous claims to the contrary, compounding pharmacies are dispensing compounded versions of those life-enhancing drugs to hundreds of thousands of patients. I get that Novo doesn’t like it, but the answer is not to restrict patient access, as Novo’s October 21 letter attempts, it’s for it to fix its supply chain. #compounding #pharmacycompounding #compoundedGLP1s Alliance for Pharmacy Compounding

APC hosted a reporter briefing Wednesday focused on how FDA’s abrupt resolution of the tirzepatide injection shortage is affecting patients. More than 30 journalists participated. You can view the first 22 minutes of that 90-minute briefing here — easily the best part IMO. The four pharmacists we feature — Scott Welch, Jennifer Burch, PharmD, CDCES, FNCAP, FAPC, John Herr, and Shelbi Witt — tell about patient uncertainty, drug unavailability, a turn by some to illicit substances, and the general havoc FDA’s action has wrought. And right in the center of that havoc is pharmacists, playing clinician, therapist, and advocate for their dispossessed patients. It’s worth 22 minutes of your time. #compounding #pharmacycompounding #compoundedGLP1s Alliance for Pharmacy Compounding