The Outsourcing Facilities Association (OFA) announced that it has reached a settlement agreement with the FDA that spurs the FDA to promptly review long-pending nominations for active pharmaceutical ingredients for use by FDA-registered outsourcing facilities to compound drugs needed by patients.
The settlement of a federal lawsuit filed by OFA will allow facilities registered under Section 503B of the Federal Food, Drug and Cosmetic Act to improve health care provider and patient access to certain medications – such as treatments for heart conditions, infections, pain and ocular complications after cataract surgery – and to ease drug shortages in a timely manner.
Congress created the class of 503B outsourcing facilities in 2013 to ensure the safety of the nation’s supply of compounded sterile drugs, in response to an urgent safety crisis. The FDA was directed to identify active pharmaceutical ingredients – API, or bulk drug substances – for which there is a clinical need. The FDA accepts nominations for this “clinical need” list, but many of these nominations became stuck at the first step in the agency’s review and categorization process.
According to the settlement agreement, the FDA will expeditiously categorize pending and new API nominations. First, the FDA intends to categorize within one year all uncategorized nominations that were pending as of June 14, 2022. Second, within three months thereafter, the FDA will reconsider nominations that were initially incomplete but for which FDA received supplemental information by June 14, 2022. Third, FDA will endeavor to categorize new nominations on the first business day of each month, or at least every three months.
“The FDA’s commitment to prioritize the nomination process is a welcome step toward identifying all API for which there is a clinical need,” said Lee H. Rosebush, Partner at the BakerHostetler law firm and Chairman and General Counsel of OFA. “This goal will remain a focus of OFA as a key part of our public health mission – patients are waiting for these therapies.”
The settlement agreement resolved a complaint filed on June 14, 2022, by OFA against the FDA and the U.S. Department of Health and Human Services, alleging violations of the Administrative Procedure Act. Following the settlement, the case was voluntarily dismissed by OFA on Oct. 4 in the U.S. District Court for the District of Columbia.
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