§356b. Reports of postmarketing studies

(a) Submission

(1) In general

A sponsor of a drug that has entered into an agreement with the Secretary to conduct a postmarketing study of a drug shall submit to the Secretary, within 1 year after the approval of such drug and annually thereafter until the study is completed or terminated, a report of the progress of the study or the reasons for the failure of the sponsor to conduct the study. The report shall be submitted in such form as is prescribed by the Secretary in regulations issued by the Secretary.

(2) Agreements prior to effective date

Any agreement entered into between the Secretary and a sponsor of a drug, prior to November 21, 1997, to conduct a postmarketing study of a drug shall be subject to the requirements of paragraph (1). An initial report for such an agreement shall be submitted within 6 months after the date of the issuance of the regulations under paragraph (1).

(b) Consideration of information as public information

Any information pertaining to a report described in subsection (a) of this section shall be considered to be public information to the extent that the information is necessary-

(1) to identify the sponsor; and

(2) to establish the status of a study described in subsection (a) of this section and the reasons, if any, for any failure to carry out the study.

(c) Status of studies and reports

The Secretary shall annually develop and publish in the Federal Register a report that provides information on the status of the postmarketing studies-

(1) that sponsors have entered into agreements to conduct; and

(2) for which reports have been submitted under subsection (a)(1) of this section.

(June 25, 1938, ch. 675, §506B, as added Pub. L. 105–115, title I, §130(a), Nov. 21, 1997, 111 Stat. 2331 .)

Effective Date

Section effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as an Effective Date of 1997 Amendment note under section 321 of this title.

Report to Congressional Committees

Section 130(b) of Pub. L. 105–115 provided that: "Not later than October 1, 2001, the Secretary shall prepare and submit to the Committee on Labor and Human Resources of the Senate and the Committee on Commerce [now Committee on Energy and Commerce] of the House of Representatives a report containing-

"(1) a summary of the reports submitted under section 506B of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 356b];

"(2) an evaluation of-

"(A) the performance of the sponsors referred to in such section in fulfilling the agreements with respect to the conduct of postmarketing studies described in such section of such Act; and

"(B) the timeliness of the Secretary's review of the postmarketing studies; and

"(3) any legislative recommendations respecting the postmarketing studies."