FDA Suspends Implementation Of The MOU And Will Undertake A Formal Rulemaking Process

FDA’s MOU Suspended - A big win for compounding pharmacies

In a status report filed March 3rd with the U.S. District Court for D.C., the U.S. Food & Drug Administration will suspend the implementation of the MOU (Memorandum of Understanding) and engage in a formal rulemaking process. This is a huge win for compounding pharmacies and the industry – the FDA will conduct a formal notice-and-comment rulemaking to implement its memorandum of understanding with states for interstate shipments of vital compounded medications.  The concession agreement comes after a ruling by a federal judge last October, that the FDA failed the requirements of the Regulatory Flexibility Act in promulgating the MOU.

Here’s Where the MOU Started

The National Association of Boards of Pharmacy (NABP) helped develop the standard MOU after more than 20 years of collaboration and stakeholder input. The MOU is supposed to help improve communication and capitalize on federal and state resources for the oversight of compounded drugs made by traditional pharmacies. In 2020, after issuing the standard MOU, FDA was sued by several compounding pharmacies ( refer to Wellness Pharmacy v. Azar); and NCPA submitted an amicus filing in the case after FDA made a standard MOU available for signature by states. In September 2021, the court remanded the standard MOU and asked the FDA to 1) certify it won’t have significant economic effects on small businesses or 2) compose a regulatory flexibility analysis.

It Might Take Awhile

While the win for pharmacies is significant, it will take patience from compounding pharmacies over the next couple of years for the process to be fully completed. In the court report, the FDA wrote, “Generally, the process to prepare and publish an NPRM, receive and review public comments, and revise and finalize the rule can take several years.” 

Now What? Here’s the FDA’s Go-Forward Plan:

  • The standard MOU from October 2020 is suspended; there is no reporting requirement for interstate pharmacy shipments according to Section 503A until the rulemaking process is finalized for the MOU.

  • Extend enforcement discretion on the five percent statutory cap on shipments for the duration of the rulemaking process.

  • Implement specific provisions of Section 503A for the engage in notice-and-comment rulemaking.

  • Set out definitions to both the provisions of § 353a(b)(3)(B)(i) (the “Standard MOU”)) and § 353a(b)(3)(B)(ii) (the five percent limit) and may arrange provisions of the MOU. The rulemaking will also consist of other provisions connected to the five percent limit of drugs compounded in states that choose not to sign the MOU.

  • It is not expected that states who have signed the standard MOU will carry out the actions defined in the MOU.

  • The standard MOU will be restructured around the content of the final ruling.

  • FDA will announce a new opportunity for all states to consider and sign the updated standard MOU.

  • An announcement will be published in the Federal Register before enforcement discretion expires.

Thoughts From a Compounding Pharmacy

“We’re pleased that compounders’ concerns and arguments have prevailed in this case,” said APC President Dave Miller, managing owner of Keystone Pharmacy in Grand Rapids, Mich.

“While this litigation resulted from what we view as FDA overreach, we do support the agency’s desire for reporting by compounded pharmacies that ship the majority of the medications they compound to patients in other states. Now, with this case settled, we’re committed to work with FDA and Congress to enact an effective reporting framework that meets FDA’s need for information and doesn’t threaten patients’ access to compounded medications. And I would add: We think there are ways to bring about that result that won’t take years and years to effect.”

References

  1. Official statement by the NCPA, 2022. FDA concedes in compounding litigation: https://ncpa.org/newsroom/qam/2022/02/24/fda-concedes-compounding-litigation

  2. Official Statement by the FDA, 2022.  Memorandum of Understanding Addressing Certain Distributions of Compounded Drugs: https://www.fda.gov/drugs/human-drug-compounding/memorandum-understanding-addressing-certain-distributions-compounded-drugs

  3. Case Filing Wellness Pharmacy v. Azar, 2020. https://a4pc.org/files/2020-10-29_Pharmacies-Sue-Over-MOU.pdf

  4. National Archives, 2020. Memorandum of Understanding Addressing Certain Distributions of Compounded Human Drug Products Between the State Board of Pharmacy or Other Appropriate State Agency and the Food and Drug Administration; Availability: https://www.federalregister.gov/documents/2020/10/27/2020-23687/memorandum-of-understanding-addressing-certain-distributions-of-compounded-human-drug-products

  5. FDA concedes in compounding MOU litigation, 2022. https://www.chaindrugreview.com/fda-concedes-in-compounding-mou-litigation/

  6. Press release: FDA concedes in compounding MOU case, 2022. https://a4pc.org/2022-02/press-release-fda-concedes-in-compounding-mou-case/

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Amy SummersFDA, MOU, 503A pharmacies