FDA settles drug compounding suit, agrees to 'speed its review of bulk ingredients'

 Back in 2014, the FDA made very clear to the growing but under-regulated pharma compounding world that it would begin implementing a new law from Congress requiring the agency to develop a list of bulk drug substances (or active ingredients) that companies may use to compound drugs.

But the nomination process for these bulk ingredients ran into a wide variety of submissions, with the FDA noting at the time that many of the nominations were not even for bulk drug substances used in compounding as active ingredients, “and none included sufficient information to justify inclusion.”

Fast forward eight years later, and the trade association for drug compounders today announced that it reached a settlement with the FDA that will spur the agency to more promptly review these long-pending nominations for active ingredients.

In 2013, Congress created what are known as 503B outsourcing facilities as part of an attempt to better safeguard these compounded drugs that didn’t have to meet the same requirements as generic or brand name drug manufacturers. The world of drug compounding at the time had ballooned with little state and federal oversight, and there was a major meningitis outbreak in 2012 in the Northeast that resulted in the deaths of more than 100 people due to contaminated steroids.

And while the Outsourcing Facility Association (OFA), the trade group announcing today’s settlement, explains on its website that outsourcing facilities “are subject to MORE QUALITY STANDARDS than other compounders and supply drugs in shortage,” the FDA has its own webpage dedicated to warning compounders about knowing their bulk suppliers, as several have received warning letters over the past several years.

OFA member and FDA-registered 503B outsourcing facility Fagron, which has its headquarters in the Netherlands, received a warning letter in 2018 for, among other violations, “basic failure in your quality system.”

Last June, OFA sued the FDA over its delays in signing off on new ingredients for the 503B list, noting that after eight years,

“FDA has added only four substances to the 503B Bulks List, all of which are for compounding topical dosage forms, not sterile drugs. Defendants’ unreasonable delay in identifying the bulk drug substances for which there is a clinical need is thwarting Congress’ purpose in creating 503B facilities and hurting public health by denying healthcare providers’ access to the safely compounded sterile drugs their patients need.”

According to the settlement, within one year, the FDA will categorize bulk drug substances that were nominated to its 503B list prior to the filing of the lawsuit, but the FDA said it only expects to categorize 25% of those ingredients that were nominated but not yet categorized every twelve weeks.

Within twelve weeks of the completion of this categorizing, the FDA also committed to reviewing for possible recategorization of all substances that were in Category 3 of the 503B list (i.e. may be eligible for inclusion on the list, but were nominated with insufficient supporting information). But the FDA didn’t make any guarantees, with the settlement noting that, “Depending on the content of the additional supporting information submitted with respect to a particular substance, FDA may move the substance to a new category or leave the substance’s categorization unchanged.”

“The FDA’s commitment to prioritize the nomination process is a welcome step toward identifying all API for which there is a clinical need,” Lee Rosebush, partner at the BakerHostetler law firm and chairman and general counsel of OFA, said in a statement.

https://endpts.com/fda-settles-drug-compounding-suit-agrees-to-speed-its-review-of-bulk-ingredients/