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Compounders prevail: Federal judge rules against FDA in MOU lawsuit

FROM APC: Judge rules in favor of compounders, against FDA in lawsuit over MOU

A federal district court judge has issued a summary judgment s/2021-09-21_MOU-Order.pdf in favor of a group of compounding pharmacies, ruling that FDA’s MOU on interstate shipments of compounded drugs violated the law, and the agency cannot enforce it.

The MOU will be remanded back to FDA, and the agency must “either certify that it will not have a significant economic effect on small businesses or prepare a regulatory flexibility analysis.”

While obviously not the end of issue, the ruling will allow APC and its coalition partners more time to work with FDA and boards of pharmacy to hopefully craft an MOU that’s less onerous for states to implement and which doesn’t expand FDA oversight beyond what the statute mandates.

The ruling was in response to a suit brought by a group of seven compounding pharmacies, led by Birmingham, Ala.-based Wellness Pharmacy, alleging several significant issues with the process FDA used to develop the MOU. It was a risky move for those pharmacies, but one that paid off.

The plaintiff pharmacies were Medquest Pharmacy, Wellness Pharmacy, Madame Rx, KEBD Enterprises, Hartley Medical Center Pharmacy, Womens International Pharmacy, and VLS Pharmacy. APC was party to an amicus brief filed on behalf of the plaintiffs.

The court found that, because FDA made arbitrary decisions that have “significant binding legal consequences for plaintiffs and pharmacies across the country, and […] signals a substantive change in the current legal regime governing interstate compounding,” the MOU becomes a legislative rule. “As a result,” wrote United States District Judge Christopher Cooper, “FDA was required to comply with the Regulatory Flexibility Act before issuing it. It did not.”

“This was a great piece of news,” said APC Board Chair Shawn Hodges. “We were certain FDA overstepped its authority. And it was heartening to have Judge Cooper see the logic in our argument. I think it will help bring us to an MOU that’s fairer, and hopefully one APC can wholeheartedly endorse.”

Because it was released just this afternoon, we haven’t had time to study the 38-page ruling< 2021-09-21_MOU-Order.pdf> in depth. We’ll have a more detailed analysis in this week’s Compounding Connectionsnewsletter, and we’ll certainly keep members informed of what happens next. It won’t be long: “The Court,” Cooper wrote, “will request a progress report from the agency within sixty days.”

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