The voice for pharmacy compounding • August 7, 2020
Enjoy our latest edition. Send your suggestions and questions to info@a4pc.org
Shawn Hodges
APC President
Dear friend,

Quick: Think about your members of Congress -- your representative, your senator. Can you see them in your mind’s eye? Good. Hold that image.

Now: Think about the biggest issues threatening your pharmacy compounding patients and practice.

Maybe it’s NASEM’s flawed cBHT report and the likelihood of FDA restrictions on cBHT that may result. (In a 2019 survey 82% of APC members said cBHT comprised at least 20% of their compounding business. I suspect few of us could easily survive a loss of one-fifth of our business.)

If you ship out-of-state, it may be FDA’s final MOU and the threat by several states not to sign it -- a result that could be catastrophic for many of us.

If you compound for animals, maybe it’s the draft animal compounding GFI FDA’s Center for Veterinary Medicine has proposed, which will hurt veterinary care and raise the costs of compounded pet meds across the board.

For some of you who process insurance, it might be the recent ESI/Tricare recoupment attempt -- or third-party reimbursement issues in general.

Okay, now think back to the face of your member of Congress. Imagine yourself mentioning any one of those issues above to him or her. What’s the look on their face? Recognition? Understanding? Or cluelessness?

For many members of Congress, it may be cluelessness -- and that’s not the fault of your member of Congress. It’s our fault.

The only way members of Congress can help with the issues confronting pharmacy compounding are if we -- you! -- tell them. On every one of the issues mentioned above, Congress intervening on our behalf with FDA or Tricare is the best way to stop the kind of over-reach that has made those issues threats to you in the first place. But we -- you! -- have to tell our story.

Starting September 10 and running through the rest of September and October, we have a chance to brief more than 50 members of Congress in a series of virtual meetings targeting key officials who sit on committees with oversight over FDA and Tricare. We need you to be a part of as many of those meetings at possible. Read below for details on how to participate, and let us know which meetings you’ll join.

We need members of Congress to recognize how these issues affect patients and compounders, and we can’t tell the story without you, as constituents.

Now, read on about the five big things you need to know this week!

Best,
Shawn
You can reach Shawn at shodges@innovationcompounding.com.
August 11 -- Live CE webinar: Putting Safety at the Center of Your Compounding Operation; 2:00 to 3:00 pm EDT

August 25 -- Live CE webinar: Accreditation, Inspection, Credentialing, Oh My!; 2:00 to 3:00 pm EDT

September 29 -- Live CE webinar:
1. There's a letter circulating in Congress, and we need your representative to sign it
You already know we need to put the brakes on FDA's GFI on veterinary compounding. But thanks to some friends in Congress there's an easy way you can help.

Three members of Congress -- Ted Yoho (R-FL, also a veterinarian), Mark Pocan (D-WI), and Donald Norcross (D-NJ) -- have written a "Dear Colleague" letter to their peers, asking for signatures on a letter to FDA Commissioner Stephen Hahn. They want Hahn to withdraw GFI #256.

Your to-do: Contact your member of Congress and ask them to sign the Norcross-Pocan- Yoho letter.

Heck, we've made it even simpler. We've created a sample message and we have a website that lets you send it in a couple of clicks.

SO PLEASE ACT NOW! Ask your representative to look for the "Dear Colleague" letter -- or reach out to Norcross, Pocan, or Yoho -- and sign onto the message asking FDA to withdraw GFI #256.
2. You're under attack -- and you can fight back
You are aware that compounding is under attack, right?

  • The FDA wants to regulate veterinary compounding with a draft GFI that is out of touch with reality.
  • A poorly researched study on compounded BHT could be used to cripple or eliminate the practice.
  • The Tricare clawbacks are only suspended and could start again (and expand) any time.
  • The FDA is pushing a horribly flawed idea for an MOU that several states have already said they won’t sign.

You can't sit still. You need to be heard by the legislators who can make a difference.

And that's what Compounders on Capitol Hill is about, even if it's virtual this year.

APC is scheduling meetings -- 50 virtual meetings -- with the members of Congress who sit on committees crucial to stopping these attacks. We need you there. There are no excuses -- no travel, no hotel, no Covid concerns. You can bring your voice from home and help make a difference for the profession.

Here's what's happening: By the middle of next week, you'll receive an email with the names of those 50 critical members of Congress. We need you to tell us which virtual visits you can attend.

We also need you to come to the orientation session -- the afternoon of September 10, where you'll learn the details of those four issues. In fact APC's Scott Brunner explains it best in this quickie video:
Doing nothing is not the answer. Doing nothing means we’ll lose on those four issues, and your patients (and compounding practice) will be the worse for it.

So do something. Register for CCH Virtual to be prepared. Your voice can make a difference.

3. cBHT Coalition emerges in wake of NASEM report

Compounders and prescribers of cBHT are organizing in the wake of the recently released NASEM study of compounded Bioidentical Hormone Therapy, released July 1. A loose coalition convened by Dr. Daved Rosensweet has begun to develop strategies and tactics aimed at demonstrating to FDA and others the clear safety and effectiveness of cBHT. APC’s CEO Scott Brunner, CAE, is co-chairing the coalition with Dr. Rosensweet, and several APC members are serving on committees the coalition has formed.

"The NASEM study was flawed in numerous ways,” said APC President Shawn Hodges, “APC made that case in its public statement after it was released. But because its findings support FDA’s longstanding opposition to cBHT, it’s likely to be influential in FDA’s anticipated attempts to prohibit or curtail cBHT. We must confront the errors of that NASEM report with solid peer-reviewed research and patient outcomes data. We’ll need to make that case to FDA, to members of Congress, and to the media if we want to preserve cBHT as a viable therapy for millions of Americans. That’s why it’s important for APC and its members to engage with patients and prescribers in this emerging coalition. We’ll have a much greater chance of success together than separately."

Here's the plan for the coalition, and what it's trying to achieve:

First and foremost, the coalition is dedicated to demonstrating the safety and effectiveness of compounded bioidentical hormone therapy and preserving its place as a treatment option for millions of Americans.

It will do that through a combination of advocacy, communications, and presentation of compelling scientific data. The goal: a regulatory framework in which cBHT remains a viable, accessible treatment option for patients.

The outcomes its working toward:

  • ACCESS: That timely, affordable, quality-assured cBHT therapy is available to and accessible by patients.
  • ADVOCACY: That state and federal regulation recognizes and supports the safety and effectiveness of cBHT in treating patients.
  • EXPERTISE: That both prescribers and pharmacy compounders have the knowledge and expertise to treat patients with cBHT.
  • PERCEPTION: Healthcare consumers and the professional medical community generally recognize cBHT as a safe and effective treatment option.

The coalition committee will begin meeting soon, and we would love to have you join. You can volunteer here to serve on a cBHT Coalition committee.

Stay tuned for updates and likely calls-to-action as the coalition ramps up.
4. Two pharmacy students scored a couple of great scholarships from the foundation

Congratulations to the first winners of the new Pharmacy Compounding Foundation and Pharmacists Mutual Compounding Scholarship!

Brianna Hassett
PharmD Candidate 2021
Southwestern Oklahoma State University
Weatherford, OK

Natalia Swiderski
PharmD Candidate 2020
Fairleigh Dickinson University
Florham Park, NJ
Through the generosity of the Pharmacists Mutual Insurance Company, the Pharmacy Compounding Foundation they were each awarded a $2,500 scholarship for demonstrating a commitment to a career in compounding pharmacy in the United States.

The Pharmacy Compounding Foundation and Pharmacists Mutual Compounding Scholarship is one of several student scholarship opportunities offered by the Pharmacy Compounding Foundation. You can find more information about all of them at A4PC.org/scholarships.

And remember: You can support programs like this by giving to the Pharmacy Compounding Foundation here.
5. Introducing the Malmberg Award -- and your chance to nominate someone

Created this year by the APC Board of Directors to honor long-time compounding advocates George and Lucy Malmberg, APC is proud to announce a call for nominations for the the inaugural George & Lucy Malmberg APC Advocacy Champion Award.

If you know someone who stands out as a champion for the interests of compounders and the compounding profession -- who has demonstrated a passion for advocacy and political engagement -- that's the kind of person who we want to hear about.

APC is accepting nominations (including self nominations) through August 31; just send an email with the name of the person you’re nominating and an explanation of their qualifications for the award. The award will be presented next month at the orientation session of Compounders on Capitol Hill Virtual.

Visit A4PC.org/malmbergaward for all the details, requirements, and how to file a nomination.