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The voice for pharmacy compounding | October 30, 2020
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THIS EDITION SPONSORED BY MEDISCA
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MEDISCA is the leader in providing turnkey solutions to the pharmaceutical compounding industry and allied health care professionals worldwide.
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Through its global partners, LP3 Network and MEDISCA Network, MEDISCA supports prescribers, pharmacists and pharmacy technicians engaged in personalized medicine by offering quality products, educational training, and technical support services. MEDISCA proudly celebrates over 30 years of industry-leading excellence. Our perennial pursuit to continuously address growing demands in this evolving field is fueled by our dedication to our customers and the compounding industry. MEDISCA is established in Canada, the United States, the United Kingdom and Australia.
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From the President
|  Shawn Hodges
APC President |
Dear ,
"Disappointing, but not surprising."
As you'll read below, that was our response this week to FDA's posting in the Federal Register of a final MOU on interstate distributions of inordinate quantities of compounded drugs.
It's also my view of the filing, a day after the news broke, of a lawsuit against FDA by seven compounding pharmacies (six of which are APC members). It's disappointing that the only recourse left to compounders is litigation. We warned FDA officials multiple times that they needed to get the MOU right in order to avoid that litigation. But it's also no surprise that they didn't listen.
As to APC's role in all this, we're doing a couple of important things you need to know about.
Next week, we'll be sending a letter and questionnaire to state boards of pharmacy to brief them on the situation and to get feedback on their intention regarding the MOU (you know, the info-gathering that FDA was supposed to do but didn't): Do they have concerns about the MOU? Do they plan to sign? Do they have authority to sign? Armed with those responses, we'll determine strategies for pushing back against FDA's actions.
In addition, the APC Board of Directors will soon consider whether to file an amicus brief with the court in support of the above-mentioned lawsuit. Those responses to our board of pharmacy questionnaire could help inform that amicus if we choose to pursue it.
Read on for more details on this issue (and for other news, too), and stay tuned as we figure out next steps.
Yours In Health,
Shawn
You can reach Shawn at [email protected]. |
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Foundation to fund NASEM study analysis
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.
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FDA posts final MOU on interstate shipments
With clearance from the Office of Management and Budget, FDA has posted a final but deeply flawed memorandum of understanding with states on interstate shipments of compounded medications.
It's an MOU that puts states between a rock and hard place. The rock: Sign the MOU and dump a significant -- and unfunded -- administrative burden on the board of pharmacy. The hard place: Don't sign, and have compounders restricted to shipping out-of-state no more than five percent of all compounded medications they dispense (yes, including patient-specific meds).
This was clearly not Congress's intent, but the FDA has charged ahead regardless.
- It ignored the intention of Congress.
- It ignored the state boards of pharmacy, never seeking their input on the MOU. (Instead, it relied on the National Association of Boards of Pharmacy, which itself has seemed oblivious to the concerns raised by stakeholders.)
- It ignored input from members of Congress -- delivered via phone call, letter, and committee reports as recently as this summer.
- It seems intent on grabbing for itself authority over patient-specific dispensing, long the purview of states and not of the federal government.
APC expressed its disappointment (but not surprise) in a news release earlier this week -- read it here.
And, not surprisingly, the first lawsuit has already been filed by a group of seven pharmacies against HHS and FDA, which points out that "[T]he Final Standard MOU is defective both procedurally and substantively."
Next month, the APC Board of Directors will consider filling an amicus brief in support of that lawsuit.
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EduCon stays virtual for 2021
EduCon 2021 will be virtual (in light of NHIA transitioning their originally in-person Austin, Texas, convention to a virtual event), sometime in early May. We'll announce dates shortly.
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Tempted by peptides? Don't do it.
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.
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We're up to 25 signers on joint cBHT letter
Thanks to our targeted visits with members of Congress (and your great participation in those), we're up to 25 House members who have signed the joint letter to FDA on cBHT. Don't see your member of Congress listed? Reach out to them pronto! Here's talking points (PDF). And here's the easiest way to reach out.
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Biggs
Bishop (Dan)
Bishop (Sanford)
Brownley
Carter (Buddy)
Carter (John)
Cuellar
DeFazio
Diaz-Balart
Fleischmann
Green
Griffith
Herrera Beutler
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Joyce
Jackson Lee
Kennedy (Joe)
Moolenaar
Murphy
Ocasio-Cortez
Olson
Pocan
Posey
Roe
Ruppersberger
Stivers
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