We’ve been talking the last couple of weeks about the FDA’s sudden (and, let’s be real, unjustified) decision to ban compounding* with desiccated thyroid extract — DTE.
It’s time to move from talking about it to doing something. APC’s on it.
We’re tackling the issue from a few angles, and yes, we need your help to make it happen. The goal is to press the FDA to rethink its decision through a combination of political pressure from Congress and (and here’s where you come in) the grassroots campaign we’re launching.
At Compounders on Capitol Hill, the DTE issue is our number-one talking point. When members meet with representatives and senators, they’ll be explaining how the FDA is taking away a medication critical for some of their constituents, and with no rational justification (or proper procedure).
Then comes that grassroots campaign. We’re hoping your patients can do two things to help, and we’ve created a webpage to make it easy: Compounding.com/thyroid.
The first is to reach out to their members of Congress directly. Let them know that they need DTE because the artificial stuff doesn’t cut it. That simple communication — “I’m a constituent and I need DTE” — will hit home.
The second is to share testimonials. Tell us, in writing or by video, how DTE has made a difference in their lives, and why they can’t use the artificial version. We want to show the real patient impact of FDA’s decision. And just like those messages to Congress, a heartfelt, personal story is a powerful tool to bring to bear.
How we make it easy: On Compounding.com/thyroid you’ll find an easy-to-use tool for your patients to email their members of Congress. It even has a sample message they can use, and the whole thing is automated. There’s also a button for them to share their testimonial (which can be anonymous, of course).
As for you, to help reach out to patients, we’ve got materials you can grab like sample emails and printable bag stuffers. Please use them! Every message to Congress and every testimonial we can share is another bit of pressure on the FDA.
And if you’re hosting a legislator’s visit, or you’ve got one (or two) in your contacts list, we’ve also got a slick PDF issue brief you can share with ’em.
The agency’s decision to re-classify DTE as a biologic — and thus out of bounds for compounding — is problematic on a host of levels; you can read the nitty-gritty details here. The good news is that it means there are a lot of ways to push back against the decision — the science (or lack thereof), precedent (or lack thereof), procedure (or lack thereof), even regulatory authority (or lack thereof). And, with your help, we’re going to use all of them to preserve patient access to a life-changing drug.
* It’s not just compounding. The ruling means a lot of hoops for commercial drug makers, too. It’s a real mess.