FDA Guidance Document Describes Enforcement Priorities for Unapproved New Drugs

September 29, 2011 9:10 am

Food and Drug Administration (FDA) has published a guidance document detailing the agency’s enforcement priorities for unapproved new drugs. Specifically, the guidance aims to clarify for FDA personnel and industry how FDA intends to exercise enforcement discretion regarding unapproved drugs and to emphasize that illegally marketed drugs must obtain FDA approval. “FDA estimates that in the United States today perhaps as many as several thousand drug products are marketed illegally without required FDA approval.” The document outlines the categories that will continue to be considered a higher priority for enforcement actions including unapproved drugs with potential safety risks or those that lack evidence of effectiveness, health fraud drugs that make deceptive claims, and drugs that are reformulated to evade an FDA enforcement action. Drugs that “present direct challenges to the new drug approval and OTC drug monograph systems” and unapproved new drugs that violate the Federal Food, Drug, and Cosmetic Act “in other ways” are also included on the high priority list. FDA notes that the agency may potentially exercise enforcement discretion regarding “unapproved drug products that are being commercially used or sold as of September 19, 2011.” And the document indicates that “All unapproved drugs introduced onto the market after that date are subject to immediate enforcement action at any time, without prior notice and without regard to the enforcement priorities set forth.” The document also describes instances when a notice of enforcement may be issued and factors that may be considered in determining whether the agency may allow continued marketing of a product. “Guidance for FDA Staff and Industry: Marketed Unapproved Drugs–Compliance Policy Guide” (PDF) is available for download from the FDA Web site.