August 23, 2024
What we’ll be talking about at CCH
When we get together on Capitol Hill to meet with legislators and their staffs, as much as we’d like to talk about a half-dozen issues (easily!), we’re going to be focusing on the three most important.
Shortage drug compounding. We think this meeting is a good opportunity to talk about the drug supply chain — in case you haven’t noticed, it’s had some problems lately. There are supply chain issues that can be fixed, and compounders can play an enhanced role in filling the gap. To be able to do that, though, we need to expand the definition of drug shortage so FDA can better anticipate and prepare, provide a longer tail for 503Bs when a shortage ends, and place stricter requirements on drugmakers for anticipating and reporting shortages.
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. (Read more about the issue here.)
GLP-1 compounding: fact v. 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 used to call that “lying.”) We see the push against GLP-1 compounding as part of a larger effort against shortage compounding in general.
The critical point we need to get across are the differences between counterfeits and legitimate compounding, focusing on the care and compliance legitimate compounders are taking with GLP-1s … and to urge legislators not to believe everything they read in the media.
