DOJ Directive Points to Heightened Scrutiny of FDA-Regulated Companies
DOJ's National Fraud Enforcement Division issued Directive 26-12 on corporate enforcement, which practitioners read as a signal that FDA-regulated industries face elevated fraud scrutiny.
On October 1, 2026, Assistant Attorney General Colin McDonald, who leads DOJ's National Fraud Enforcement Division, issued Directive 26-12, titled "Corporate Enforcement in the Fight Against Fraud," according to a Holland & Knight alert. The law firm's analysis frames the directive as a signal that FDA-regulated industries may face enhanced scrutiny.
Why it matters: a division-level enforcement directive typically signals where charging, settlement, or pilot activity is being prioritized, and it can affect how targets are selected, how cooperation and self-disclosure are credited, and what remediation or compliance expectations attach to resolution. For pharmaceutical, device, and other regulated manufacturers, the practical consequence is a higher probability that marketing, reimbursement, safety-reporting, or promotional conduct is examined through a fraud lens — areas where the FDA's own compliance regime already sits.
What is uncertain: the alert reviewed here is truncated, and the full text of the directive is not reproduced in the available source. Its precise scope, any carve-outs, and whether it alters existing cooperation credit or resolution practice cannot be confirmed from this material.
What to watch: the directive's published text, any accompanying DOJ or agency announcements, and the first enforcement actions or declinations showing how it is applied. Counsel should test current exposure in internal-company, speaker-program, and reimbursement arrangements against the announced priorities.