This week the Pharmacy Compounding Foundation voted to take a leadership role in the effort to protect cBHT. The Foundation board approved substantial funding for an objective, third-party, comprehensive analysis of the NASEM cBHT study.
What that means
There’s much to question about NASEM’s FDA-funded cBHT study:
The appropriateness of the study approach
The composition of the committee (plus any demonstrated bias of reviewers)
The limited scope of the research it reviewed — why and how were only a handful of the hundreds of cBHT studies considered?
Right now, that NASEM study carries a strong sense of legitimacy simply because there’s been no comprehensive, objective effort to refute it. But its flaws mean it must not come to be seen as the definitive word on the safety efficacy of cBHT. Thanks to the foundation, it won’t be.
The foundation-funded analysis of the NASEM study should be available by early 2021. Our aim will be to share it with FDA officials, as well as members of Congress and the news media.
This isn’t an inexpensive undertaking, and PCF deserves kudos for its leadership in funding the analysis. Keep that in mind, and please, give to the foundation. Help support it, so it can help support the practice and future of compounding.
Donors in the past have made this coming analysis possible; they paid it forward. Now it’s your turn to do the same.
Personal or corporate, your donations to the foundation are tax-deductible. And there’s no better time to support the foundation as it takes the lead in the fight for cBHT.
Yes, like you, we’ve seen those recent marketing emails and how-to CE courses touting compounded peptides, many of them supported by prescribers. Remember that FDA does not control the practice of medicine, and education can be provided on any topic. Many in the physician and education world may be unaware of restrictions on peptide compounding, and some may be asking you to prepare the products they have been learning about. But FDA has explicit rules that restrict what 503A pharmacies can compound and dispense. Using any chemical as an active ingredient in a human compound is not allowed unless:
It has a USP monograph; or
Is an ingredient in an FDA-approved drug; or
Is on the FDA 503A “positive” list; or
Is on Category 1 of FDA’s Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act.
Most peptides do not currently meet any of those conditions.
We know you may be getting pressure from certain physicians to compound peptides, and we understand you risk losing the relationship with that physician by saying no. It’s a hard choice to make. But the rules are the rules, like them or not, and compounders who compound peptides are not just inviting FDA scrutiny, but they risk giving the rest of your rule-following profession a black eye. Until it’s legal, don’t compound peptides that don’t meet 503A active ingredient criteria.
California’s Board of Pharmacy is considering a rather overzealous attempt to limit animal compounding from bulks, and APC is happy to support our friends at the California Pharmacists Association with a letter to the BoP opposing those changes.
Congress wanted to help the hemp industry. Hemp isn’t marijuana, although they are related. So in the Agriculture Improvement Act (AIA) of 2018 it removed hemp from the definition of marijuana, and gave control of regulating hemp from the DEA to the U.S. Department of Agriculture.
If it has a THC concentration of “not more than 0.3 percent on a dry weight basis,” it was considered “hemp” and regulation went to USDA.
The pharma connection: This also applies to CBD products. And in 2019, the DEA told industry that “… after a review of the AIA, it determined that synthetic cannabinols (CBD) containing less than 0.3% Δ9-THC met the definition of “hemp” and therefore were no longer scheduled drugs under the CSA.”
So synthetic CBD was also cool, as long as it had little to no THC.
But now DEA has issued a interim final rule … and seems to be saying the opposite. Any synthetically derived tetrahydrocannabinols, it said, remain schedule I drugs, even if the THC is less than 0.3%.
“‘For synthetically derived tetrahydrocannabinols, the concentration of Δ9-THC is not a determining factor in whether the material is a controlled substance.’ Thus, all synthetic forms of cannabis and its derivatives, regardless of the Δ9-THC content, are still subject to DEA control.”
So a lot of CBD makers — not to mention hemp growers and producers — are very, very upset, especially since the DEA skipped the whole ‘notice and comment’ period to let people know about this. Cue the lawsuits.
“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.”
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?
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.
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).
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.
