A recent Food and Drug Administration (FDA) Warning Letter suggests that the agency will not hesitate, when necessary, to exercise its power to enforce postmarketing requirements (PMRs) for approved drug products. The Warning Letter states that the recipient company failed to submit a required study protocol and final study report, pursuant to the company’s PMRs, and, therefore, the drug products are misbranded under the Federal Food, Drug, and Cosmetic Act (FDCA). This Client Alert will focus on the FDA’s general concerns and its enforcement approach rather than the specific PMRs in the particular case addressed in the Warning Letter. The Warning Letter is significant because it represents that the agency will take enforcement action against a company for failure to comply with PMRs. The industry will have to wait and see whether the Warning Letter represents a new wave of enforcement, but it signals that the FDA will act and companies should stay focused on complying with PMRs.
Click the link below to read the full alert.