September 13, 2024
Be fruitful and multiply … our messaging, that is
Even if you didn’t attend Compounders on Capitol Hill, you can multiply the effect of those Hill visits: Reach out — from right there at home — to your members of Congress.
There are four priority issues we need you to talk about:
- Alleviating drug shortages. In case you haven’t noticed, the drug supply chain has had some problems lately. One obvious fix for helping FDA better anticipate and prepare for drug shortages is to expand the sources of drug supply data FDA can draw from. Right now, it’s only from drugmakers, but doesn’t it make sense that they get shortage info from hospitals and pharmacies, too? We also need a longer tail for 503Bs when a shortage ends. We’re supporting a proposal to do those things and more. (Click here for our PDF issue brief.)
- Concerns about FDA’s proposed demonstrably difficult to compound (DDC) list. The FDA is proposing adding entire drug categories to the 503A DDC list, which, frankly, it doesn’t have the legal right to do. (Categories can only be added to the 503B DDC list.)
Why would it do this? We’re concerned that it might be the first step toward restricting hormone compounding and possibly GLP-1 compounding … possibly under pressure from drug makers. (Click here for our PDF issue brief.)
- GLP-1 compounding: Separate fact from fiction. We all know how drug makers are fighting tooth-and-nail against GLP-1 compounding, spreading a lot of misinformation in the process. We see the push against GLP-1 compounding as part of a larger effort against shortage compounding in general.
The truth about compounding is far different, and we aim to brief congressional staffers so that they’ll know not to believe everything they read in the media. (Click here for our PDF issue brief.)
- Animal drug compounding from bulk substances. Until recently, veterinarians could keep a variety of compounded medications in stock for office use. That allowed them to begin treatment immediately and reduce animal suffering. But FDA’s Center for Veterinary Medicine is jeopardizing that care.
We need you to ask your member of Congress to contact CVM and express concerns about how the FDA Center for Veterinary Medicine is approaching the list of approved bulk drugs under GFI 256 — including the slowness in developing a robust set of “listed” drugs that can be compounded from bulk substances and the arbitrary nature of drugs they decline to add to the list. (Click here for our PDF issue brief.)
Getting the message out is easy. We’ve even written a message for you (that you can edit, of course). Click here, enter your address, and our system will identify your members of Congress. Then sending the message takes just a couple of clicks.
It’s a big week of opportunity ahead for pharmacy compounding. Thanks for your support — from wherever you find yourself next Wednesday.
