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News & Press: Breaking News

Looking to end the impasse, IACP and its partners have proposed a "middle way" for FDA's MOU

Friday, August 2, 2019  
Posted by: Jennnifer Petska
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By Scott Brunner, CAE

scott@iacprx.org

 

In hopes of ending the stalemate with FDA over the proposed memorandum of understanding with states, IACP and its partners NCPA and APhA last week submitted to FDA a letter outlining a "middle way" forward. We've proposed a framework for an MOU that we believe accommodates FDA's need for data on the interstate shipment of compounded medications while preserving state board of pharmacy oversight of patient-specific dispensing and assuring patient access to essential compounded medications.
 
If that sounds like a remarkable act of needle-threading, well...it is. That's why we think FDA may pay attention to it: because it helps them get out of the corner they've painted themselves into with their earlier and (we believe) onerous iterations of a proposed MOU that many state boards of pharmacy have indicated they may not sign.
 
Drafted earlier this year by IACP's legislative consultant David Pore at my request, our "middle way" concept was shopped to and improved upon by IACP member leaders and industry partners through spring and early summer. It was presented by a coalition of IACP members, along with representatives of NCPA, APhA, and NHIA, to FDA in June at an invitation-only listening session. We followed up last week with the joint letter to FDA, which is signed by IACP, NCPA, and APhA.
 
Here, in broad strokes, are the main points we've proposed (PLEASE READ our letter to FDA, linked below, which presents more detail and nuance than this bulleted summary):
  • By defining the term "distribution" to include patient specific dispensing for purposes of both the MOU and the statutory default 5% cap for pharmacies in states that do not sign the MOU - as FDA's second iteration of the proposed MOU does - FDA has asserted regulatory authority over the very essence of the practice of pharmacy in a way that is inconsistent with the Federal Food, Drug, and Cosmetic Act and that will lead to serious patient access problems throughout the country.
  • We believe the FDA should incorporate the suggested redline changes to the MOU (related to requirements on the states but without the footnote on "distribution") submitted by NABP into a new, revised draft MOU. 
  • We believe a workable solution can strike a better balance between FDA's need for data on the interstate shipments of compounded medications and the ability of patients to get their compounded medications from the state-licensed and compliant pharmacy of their choosing.
  • Our proposed solution to allow for robust patient access is for FDA to rescind the current draft MOU and issue a new revised draft MOU for public comment that accomplishes the following:
    • For purposes of the MOU and the 5% cap, define the term "distribution" to mean a transfer of a compounded drug product to a prescribing physician:
    1. where authorized under applicable state pharmacy laws,
    2. pursuant to a prescription drug order from the physician,
    3. that indicates a medical need for administration to the patient in an office or clinical setting.
    • "Distributions" could only be done by 503A pharmacies in limited quantities prior to receipt of a valid prescription order.
    • Establish within the MOU that the administering physician must provide the pharmacy with an electronic or written prescription within 30 days of administration of the drug to the patient.
    • Establish within the revised draft MOU on the prescription requirement that a 503A pharmacy is permitted to "distribute", pursuant to a drug order, a limited quantity.
    • Establish within the revised draft MOU a requirement that a drug order for limited quantity office-use compounding must indicate that the compounded medication is not currently available from outsourcing facilities in the limited quantity needed by the prescriber.
    • For purposes of the 50% inordinate quantities threshold that triggers tracking, investigating and reporting requirements on the state BOPs, include both "distribution" and "dispensing" (all interstate shipments).
    • Establish a good faith/reasonable effort safe harbor clause for pharmacies on the prescription requirement in the MOU.
    • Define what will happen when compounders exceed the 50% distribution threshold, which will include a statement that FDA will be using the information it collects on interstate shipments only to inform its risk-based inspection schedule.
  • Our proposal for a revised MOU on the prescription requirement would settle the legal questions surrounding FDA's redefining of key statutory terms, would draw broad stakeholder support, and would have the effect of greatly incentivizing states to sign the MOU. It would give the FDA key data on interstate distributions (and dispensing) of compounded drug products to better inform the agency's risk-based inspection schedule, while not applying an arbitrary cap on patient specific dispensing that is not consistent with the statute and that would severely limit access to medications.
I encourage you to read the letter thoroughly and understand what we're proposing and why we believe it's a smart move strategically. It's our best attempt at helping FDA avoid the litigation that is sure to follow if the agency finalizes the MOU in its current proposed form. Not only that, but resolving this issue also will allow IACP and its partners to focus on other pressing policy issues impacting your compounding practice.

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