April 17, 2019
Dear IACP Member:
Please take a moment to read this message in its entirety. It contains an urgent request for your help.
We're finally seeing glimmers of light on the regulatory front that can spell opportunity in reining-in FDA overreach on compounding -
but we need your help.
For one thing, a letter to FDA is circulating in Congress.
It takes FDA to task for over the draft Memorandum of Understanding it has proposed and requests several adjustments. We're working to get as many members of Congress as possible to sign the letter -
and we've only got about eight weeks to do it
. The more signatures, the less FDA can afford to ignore it, and the more likely we can avoid the imposition of an onerous 5 percent cap on shipped compounds in states across the U.S.
For another, Congress looks willing to back-up that letter with legislation if FDA doesn't listen and act accordingly.
would enact in law many of the provisions on which we've been seeking compromise with FDA for years. As with the letter, we're seeking as many members of Congress as possible to sign-on as cosponsors of that legislation - and to help tee it up for an actual hearing in Congress.
And finally, at the urging of IACP and many other groups,
the Trump Administration last week took a major step
toward ensuring that FDA and other agencies stop back-door regulation
via guidance documents and instead follow proper administrative protocol in promulgating regulation. It's a win that should curtail FDA's habit of regulating compounding without proper stakeholder input on proposed rules.
The combination of these three developments creates an opportunity for us to bring FDA to the table on our issues.
But to make that happen, compounders like you are going to need to flex some political muscle. Here's how:
- Please attend IACP's Compounders on Capitol Hill event May 18-21 to meet with your members of Congress and urge them to sign the letter and co-sponsor the legislation. Yes, we know it's difficult to be away from your business. But visiting with them on their turf is absolutely the best way to get their attention, make your case, and get things done. It's worth the time and expense of coming to Washington, D.C., for a day or two. (And don't worry: IACP will schedule your appointments for you.)
- Respond to our call-to-action on both the congressional letter and H.R. 1959. Via our simple system, you can send an email to your members of Congress to put our issues on their radar. Add a message saying you look forward to discussing it with them when you're in D.C. in May for CCH. Takes less than two minutes.
- Look for opportunities to invite your member of Congress to visit your pharmacy. That means reaching out to their local office and working with them to schedule it at a time when the member of Congress is home in-district for a few days. When they visit your pharmacy and you share your challenges, you're equipping them to be champions for your profession.
I can't emphasize enough how important those three steps are
in positioning IACP and its partners to take advantage of this moment. Because here's the thing: We can't win this fight without you.
Will you do your part?
The future of your compounding business may depend on it.
Scott Brunner, CAE
Executive Vice President