21 U.S.C. § 356b — Reports of postmarketing studies

(a) Submission. A sponsor who has agreed with the Secretary to run a postmarketing study of a drug must submit to the Secretary, within 1 year after the drug's approval and annually after that, a report on the study's progress or the reasons it hasn't been conducted — until the study is completed or terminated. The report must use whatever form the Secretary prescribes by regulation. For a drug approved through accelerated approval, the sponsor must instead report progress on any study required under section 356(c) — including progress toward enrollment targets and milestones, and other information the Secretary requires — not later than 180 days after approval and at least every 180 days after that, until the study is completed or terminated; the Secretary must promptly publish this reported information on the FDA's website in an easily searchable format. For agreements to conduct a postmarketing study made before November 21, 1997, the same annual-reporting requirement applies, with the first report due within 6 months after the subsection (a)(1) regulations were issued. (b) Consideration of information as public information. Information from a subsection (a) report counts as public information only to the extent needed to (1) identify the sponsor, and (2) establish the status of the study and the reasons, if any, that it wasn't carried out. (c) Status of studies and reports. The Secretary must annually develop and publish, in the Federal Register, a report on the status of postmarketing studies that sponsors have agreed to conduct and for which reports have been submitted under subsection (a)(1). (d) Disclosure. If a sponsor fails to complete an agreed-upon study by its original or renegotiated deadline, the Secretary must publish a statement on the FDA's website saying the study wasn't completed, and — if the sponsor's reasons for the failure weren't satisfactory to the Secretary — a statement that the reasons weren't satisfactory. (e) Notification. For certain studies required under section 356(c)(2)(A), or under specified older Code of Federal Regulations provisions as they existed before this subsection's effective date, if a sponsor fails for reasons not satisfactory to the Secretary to complete such a study by its deadline, the Secretary may require the sponsor to notify prescribing practitioners of that failure and of the unanswered questions about clinical benefit, and where appropriate, safety, that result. Nothing in this subsection changes what studies are required under those sections, or stops the Secretary from modifying those Code of Federal Regulations provisions to require additional studies.