FDA POSTS FINAL MOU: Disappointing … but not surprising

October 26, 2020

Scott Brunner, CAE


For pharmacy compounders, this morning’s action by FDA to post to the Federal Register a final but deeply flawed memorandum of understanding with states on interstate shipments of compounded medications is disappointing … but not surprising.

“At no point in the 23 years since Congress first directed FDA to create the memorandum has FDA shown the slightest interest in concerns raised by pharmacy compounders about how FDA’s structuring of the MOU could restrict access to compounded medications for thousands of patients who rely on them,” said Scott Brunner, CAE, chief executive officer of the Alliance for Pharmacy Compounding. “Not even input from members of Congress — delivered via phone call, letter, and committee reports accompanying FDA’s annual appropriation — have been able to slow an overreaching FDA. In fact, FDA seems more intent on getting its way than on crafting a workable solution for patients, for pharmacy compounders, and for state boards of pharmacy.”

FDA seems more intent on getting its way than on crafting a workable solution for patients, for pharmacy compounders, and for state boards of pharmacy.

In adding section 503A to the Food, Drug & Cosmetic Act in 1997, Congress directed FDA to draft a memorandum of understanding to incentivize states to help FDA gather data on shipments of non-patient-specific compounded medications across states lines so that FDA could inspect and document patient safety in those pharmacies. Congress clearly meant for FDA to structure the MOU in such a way that state boards of pharmacy would be motivated to sign it. It was not Congress’s intention to limit patients’ access to compounded medications.

“Unfortunately,” said Brunner, “The MOU FDA posted today places a significant — and unfunded — administrative burden on state boards of pharmacy. Those boards get their authority and funding from state legislatures, not from Congress, and many states are now threatening not to sign it. If states won’t sign, the enhanced patient safety measures Congress aimed FDA to achieve via the MOU can’t be realized.”

Pharmacies in states that don’t sign the MOU will be restricted to shipping out-of-state no more than five percent of all compounded medications they dispense — and because pharmacy compounding is not always a local business, patients outside states that don’t sign will find access to their medications cut-off. Not only that: In states that don’t sign, compounding pharmacies that ship the bulk of their patient-specific compounded drugs out of state may be forced to close their doors, eliminating jobs and a local economic engine in the process.

“This is not the choice Congress meant FDA to offer states: A significant unfunded mandate or a job-killing cap on shipments,” said Brunner.

“Rather than working with individual state boards of pharmacy to assess each state’s concerns about the MOU and the likelihood a state would sign it in its current form, FDA instead relied on representations by the National Association of Boards of Pharmacy that, however well-intentioned, do not reflect the views of many state boards,” Brunner said.

“In fact,” said Brunner, “All along, both FDA and NABP have seemed to be oblivious to the concerns raised by stakeholders, not only about the unfunded administrative burden the MOU would place on states, but also about its expanded definition of terms in such a way as to give FDA authority over patient-specific dispensing, long the purview of states and not of the federal government.

“As a result, I suspect we’re likely to see litigation by compounding pharmacies adversely affected by the MOU. We could even see litigation by states,” said Brunner. “FDA could have worked with stakeholders on this and created a workable MOU, but as ever, it kept its own counsel, and here we are.”

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.

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