FDA to redo key pharmacy policy to win over industry

The Food and Drug Administration (FDA) headquarters in White Oak, Maryland, USA REUTERS/Andrew Kelly

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  • New interstate sales policy will likely take years
  • Many compounding pharmacies currently largely avoid FDA oversight

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(Reuters) – The U.S. Food and Drug Administration is suspending a memorandum of understanding with states governing how drugs from compounding pharmacies are sold between states and will engage in a process to develop rules of several years to adopt a new one.

The FDA action was disclosed in a court filing on Tuesday after a federal judge in Washington, D.C. dealt a blow to the agency’s oversight of specialty pharmacies in August by finding that the memorandum of understanding had been poorly developed. Rachael Pontikes, a lawyer at Reed Smith for pharmacies who challenged the memorandum of understanding in court, declined to comment. Industry trade group Alliance for Pharmacy Compounding called the FDA’s decision a “significant victory.”

The FDA did not respond to requests for comment.

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Compound medications are custom-made drugs that were traditionally formulated by state-regulated pharmacies for specific patients. The FDA has historically left the regulation of compound drugs to the states.

But in recent decades, some pharmacies have begun selling thousands of doses of regularly used mixtures for doctors to save for future use, even across state lines, prompting the FDA to fear that they act like drug makers.

In response, Congress in 1997 amended the Federal Food, Drug, and Cosmetic Act and directed the FDA to develop the Memorandum of Understanding to indicate when state pharmacy boards should report interstate sales to it. compound drugs.

Pressure to finalize the deal grew following a deadly outbreak of fungal meningitis in 2012 linked to tainted drugs made by the Massachusetts New England Compounding Center compounding pharmacy that sickened 793 people, including more of 100 died.

After several drafts and years of tussling with compounding pharmacies, the FDA unveiled a memorandum of understanding in October 2020 that would cap state-signatory pharmacies at 50%. All but five states were to sign. Litigation ensued.

Ruling for seven pharmacies in August, U.S. District Judge Christopher Cooper, appointed by former President Barack Obama, found the agency failed to consider the economic impact on small pharmacies that compound compound drugs for individual patients that are not FDA approved.

Cooper returned the MOU to the FDA for further review and asked it to report back on its plans.

In a Tuesday status report, the FDA, through attorneys from the U.S. Department of Justice, said it had decided to undergo a formal rule-making process with public notice and a period comments to implement the MoU, which could take “several years”.

The FDA said it would meanwhile continue to waive part of a 1997 law that limited pharmacies in states that had not signed the long-delayed memorandum of understanding to only dispense 5% of their drugs each year between states. He planned to start the application in October.

The case is Wellness Pharmacy Inc v. Azar, US District Court for the District of Columbia, No. 20-cv-03082.

For pharmacies: Rachael Pontikes and James Segroves of Reed Smith

For the FDA: Raquel Toledo of the US Department of Justice

Read more:

FDA to review compounding policy for major drugs and judge rules

Appeal of ex-pharmacy workers in meningitis case raises question of industry practices

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Nathalie Raymond

Nate Raymond reports on federal judiciary and litigation. He can be reached at [email protected]

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