Fairness and the FDA

Check out the latest entry in FDA Law Blog: “Lemonade from Lemons: Fairness in FDA Enforcement Actions.” It’s about executive order 13924, which says federal agencies “shall consider” fairness in enforcement actions. How might that apply to FDA?

What’s at stake in the Supreme Court?

Specifically in the Rutledge v PCMA case? The practices of thousands of community pharmacies and their patients, that’s what. Our allies explain: “States vs. PBMs at the Supreme Court: What’s at Stake for Patients.”

GFI #256: Congress sends a joint letter to FDA

A big thank you to all the members of Congress who signed onto the joint letter to FDA — led by Reps. Norcross, Pocan, and Yoho — asking that the agency withdraw GFI #256 on animal compounding. Here’s the list; read the letter here.

James R. Baird
Jaime Herrera Beutler
Andy Biggs
Dan Bishop
Sanford Bishop
Earl L. Buddy Carter
John R. Carter
Bonnie Watson Coleman
Henry Cuellar
Madeleine Dean
Jefferson Van Drew
Neal P. Dunn, M.D.
Paul A. Gosar, D.D.S.
Mark Green
Jim Hagedorn
Fred Keller
Andy Kim
Debbie Lesko
Zoe Lofgren
Donald Norcross
Ralph Norman
Eleanor Holmes Norton
Mark Pocan
Bill Posey
Denver Riggleman
David P. Roe, M.D.
Michael F.Q. San Nicolas
Kurt Schrader
David Schweikert
Christopher H. Smith
W. Gregory Steube
Van Taylor
Bruce Westerman
Ted S. Yoho, D.V.M.

Rep. Morgan Griffith pens a great op-ed

APC is loving this powerful op-ed from Congressman Griffith about the FDA’s MOU. It makes important patient access and economic arguments against the MOU as presently proposed. Please share and spread the word (and a thank-you to the congressman wouldn’t hurt, either).

Tricare stands down, ESI (gasp!) apologizes

The Tricare recoupment fiasco faced by hundreds of pharmacies across the country appears to be nearing its end, with a victory for pharmacists in sight.

In response to concerns raised by APC and its partners, Tricare has instructed Express Scripts to stop the recoupments it started in June. Pharmacies that have already suffered clawbacks will be allowed to appeal, and the standard for documentation of those appeals will now be reasonable.

APC teamed with NCPA and PAAS National to challenge the recoupment, and, over a series of conference calls with Tricare and ESI, were able to demonstrate how the recoupments themselves were often invalid, and the requirements for appeal were egregious (and, frankly, bordered on the absurd).

Attorneys Hunter Jamerson of Macaulay & Jamerson and Jeff Baird and Brad Howard of Brown & Fortunato were instrumental in assisting APC in this recoupment challenge.

Now some pharmacies will even be receiving an apology from ESI.

You’ll find details at A4PC.org/tricareclawbacks, and a video of the APC briefing call is available on Vimeo.

Nominations are still open: Run for the foundation board

The Pharmacy Compounding Foundation needs compounding pros who want to do more for the practice of pharmacy compounding.

The foundation is APC’s charitable extension. It helps fund educational and scientific programming and research — chances are you’ve seen or even joined a foundation-sponsored activity.

Join the foundation board! Help direct its mission, advance pharmacy compounding, and do more for patients. NOMINATIONS CLOSE THURSDAY, OCTOBER 15. Just click here to self-nominate!

GFI #256 comment period is closing!

The comment period for animal compounding GFI 256 is closing THURSDAY — October 15. As written, the draft guidance will restrict veterinary practice, increase prices of compounded drugs for animals, and put animal health at risk.

Two things to do, if you haven’t already:

Send your comments to FDA. We’ve made it quick and easy for you to do — just click here to send a pre-filled message (feel free to edit it).

Send an urgent message to your member of Congress asking them to sign the joint letter to FDA about the GFI. We’ve made that easy, too: Just click here.

Tricare clawback update

APC’s been working on the Tricare clawback issue, and we’ve got some pretty good news. It’s too much for a quick post here, so we’ve scheduled a (final?) briefing call THIS WEDNESDAY, October 14, at 4:00pm EDT. Free to all, but registration required — click here to do that.

Reminder: We need your help to protect cBHT

REMINDER, folks: If you know someone using compounded hormone therapy, APC is still collecting as many testimonials as possible: A4PC.org/cbhtandme. With FDA considering restricting cBHT, now is the time to show how important it is to millions of Americans. Please ask your patients (or fill the form out yourself).

And remember to ask your U.S. representative to sign onto the joint, bipartisan congressional letter to FDA Commissioner Hahn urging that the agency NOT restrict cBHT: A4PC.org/cbhtaction.


FDA is threatening cBHT restrictions. Urge your member of Congress to weigh in.

Compounders and other pharmacy professionals!

In the wake of that flawed NASEM study, FDA has said it will consider restricting compounded hormone therapy. It’s likely that cBHT patients are a good share of your business, and that the therapies you prepare have helped those patients immensely.

Although FDA has not yet proposed specific restrictions, NOW is the time to begin to educate your member of Congress about cBHT — and to ask them to sign on to a joint congressional letter to FDA raising concerns about the NASEM cBHT study that FDA funded.

Ask your U.S. House member to sign the joint letter to FDA sponsored by Reps. Pocan, Herrera-Beutler, Cuellar, and Roe.

We’ve made it easy for you to reach your representative. Click the button below and you’ll find a pre-written message — which you may customize as you wish — and send to your elected officials. Takes less than two minutes!

Thank you for your support. And if you can share your testimonial about how cBHT has helped you or your patients, please do! We have an easy form at A4PC.org/cbhtandme. We’ll be using those testimonials in our efforts to prevent FDA from restricting your patients’ healthcare!

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