SEC. 551. [21 USC §360aaa] Requirements for Dissemination of Treatment Information on Drugs or Devices

(a) IN GENERAL.—Notwithstanding sections 301(d), 502(f), and 505, and section 351 of the Public Health Service Act (42 U.S.C. 262), a manufacturer may disseminate to—

(1) a health care practitioner;

(2) a pharmacy benefit manager;

(3) a health insurance issuer;

(4) a group health plan; or

(5) a Federal or State governmental agency;

written information concerning the safety, effectiveness, or benefit of a use not described in the approved labeling of a drug or device if the manufacturer meets the requirements of subsection (b).

(b) SPECIFIC REQUIREMENTS.—A manufacturer may disseminate information under subsection (a) on a new use only if—

(1)(A) in the case of a drug, there is in effect for the drug an application filed under subsection (b) or (j) of section 505 or a biologics license issued under section 351 of the Public Health Service Act; or

(B) in the case of a device, the device is being commercially distributed in accordance with a regulation under subsection (d) or (e) of section 513, an order under subsection (f) of such section, or the approval of an application under section 515;

(2) the information meets the requirements of section 552;

(3) the information to be disseminated is not derived from clinical research conducted by another manufacturer or if it was derived from research conducted by another manufacturer, the manufacturer disseminating the information has the permission of such other manufacturer to make the dissemination;

(4) the manufacturer has, 60 days before such dissemination, submitted to the Secretary—

(A) a copy of the information to be disseminated; and

(B) any clinical trial information the manufacturer has

relating to the safety or effectiveness of the new use, any reports of clinical experience pertinent to the safety of the new use, and a summary of such information;

(5) the manufacturer has complied with the requirements of section 554 (relating to a supplemental application for such use);

(6) the manufacturer includes along with the information to be disseminated under this subsection—

(A) a prominently displayed statement that discloses—

(i) that the information concerns a use of a drug or device that has not been approved or cleared by the Food and Drug Administration;

(ii) if applicable, that the information is being disseminated at the expense of the manufacturer;

(iii) if applicable, the name of any authors of the information who are employees of, consultants to, or have received compensation from, the manufacturer, or who have a significant financial interest in the manufacturer;

(iv) the official labeling for the drug or device and all updates with respect to the labeling;

(v) if applicable, a statement that there are products or treatments that have been approved or cleared for the use that is the subject of the information being disseminated pursuant to subsection (a)(1); and

(vi) the identification of any person that has provided funding for the conduct of a study relating to the new use of a drug or device for which such information is being disseminated; and

(B) a bibliography of other articles from a scientific reference publication or scientific or medical journal that have been previously published about the use of the drug or device covered by the information disseminated (unless the information already includes such bibliography).

(c) ADDITIONAL INFORMATION.—If the Secretary determines, after providing notice of such determination and an opportunity for a meeting with respect to such determination, that the information submitted by a manufacturer under subsection (b)(3)(B), with respect to the use of a drug or device for which the manufacturer intends to disseminate information, fails to provide data, analyses, or other written matter that is objective and balanced, the Secretary may require the manufacturer to disseminate—

(1) additional objective and scientifically sound information that pertains to the safety or effectiveness of the use and is necessary to provide objectivity and balance, including any information that the manufacturer has submitted to the Secretary or, where appropriate, a summary of such information or any other information that the Secretary has authority to make available to the public; and

(2) an objective statement of the Secretary, based on data or other scientifically sound information available to the Secretary, that bears on the safety or effectiveness of the new use of the drug or device.

 

Footnote: Chapter V, Subchapter D

 

 1. This subchapter was added by section 401(a) of P.L. 105–115. Subsections (d) and (e) of such section provides the following:

(d) EFFECTIVE DATE.—The amendments made by this section shall take effect 1 year after the date of enactment of this Act, or upon the Secretary’s issuance of final regulations pursuant to subsection (c), whichever is sooner.

(e) SUNSET.—The amendments made by this section cease to be effective September 30, 2006, or 7 years after the date on which the Secretary promulgates the regulations described in subsection (c), whichever is later.