On Tuesday, Outsourcing Facilities Association, a trade association, filed a complaint in the District of Columbia against the Department of Health and Human Services (HHS) and its Secretary Xavier Becerra as well as the Food and Drug Administration (FDA) for violating the Administrative Procedure Act (APA) by not identifying bulk drug substances under Section 503B of the Food, Drug & Cosmetics Act (FD&C).
In November 2013, Congress created an FDA-regulated entity known as a “drug compounding outsourcing facility,” also known as 503B facilities, to safely compound sterile drugs. The plaintiff is a trade association for these types of FDA-registered facilities. The HHS Secretary was directed to create a “503B list” that identifies bulk drug substances (active pharmaceutical ingredients) yet has only provided four substances in the past nine years. These ingredients are necessary for a wide array of clinical drugs used by hospitals, clinics and healthcare practitioners that are used in emergency situations. The plaintiffs detailed the importance of listing these substances as there is a “legacy of unregulated and unsafe compounding practices for sterile drugs” that culminated in the 2012 fungal meningitis outbreak.
OFA noted that the process for adding a bulk drug substance to the 503B list is less complex than approving a drug for clinical use, yet almost none have ever been approved. The plaintiff claimed that the “FDA’s eight-year-plus delay is harming public health and undermining the statutory scheme by frustrating Congress’s intent to give health care providers access to sterile drugs” that are compounded in 503B facilities to help the American people.
OFA is suing for one violation of the APA in order to make the HHS add significantly more bulk drug substances to the 503B list.
The plaintiff seeks a declaration that the defendants violated the APA by “unlawfully withholding and unreasonably delaying performance of their duty to identify the bulk drug substances,” declaratory relief enjoining the defendants to identify the proper bulk drug substances, attorney’s fees and costs, and other relief.
OFA is represented by Baker & Hostetler LLP.