SEC. 551. [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)(l); 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.

SEC. 552. [360aaa-1] INFORMATION AUTHORIZED TO BE DISSEMINATED.

(a) AUTHORIZED INFORMATION. -- A manufacturer may disseminate information under section 551 on a new use only if the information --

(1) is in the form of an unabridged --

(A) reprint or copy of an article, peer-reviewed by experts qualified by scientific training or experience to evaluate the safety or effectiveness of the drug or device involved, which was published in a scientific or medical journal (as defined in section 556(5)), which is about a clinical investigation with respect to the drug or device, and which would be considered to be scientifically sound by such experts; or
(B) reference publication, described in subsection (b), that includes information about a clinical investigation with respect to the drug or device that would be considered to be scientifically sound by experts qualified by scientific training or experience to evaluate the safety or effectiveness of the drug or device that is the subject of such a clinical investigation; and

(2) is not false or misleading and would not pose a significant risk to the public health.

(b) REFERENCE PUBLICATION. -- A reference publication referred to in subsection (a)(l)(B) is a publication that --

(1) has not been written, edited, excerpted, or published specifically for, or at the request of, a manufacturer of a drug or device;
(2) has not been edited or significantly influenced by such a manufacturer;
(3) is not solely distributed through such a manufacturer but is generally available in bookstores or other distribution channels where medical textbooks are sold;
(4) does not focus on any particular drug or device of a manufacturer that disseminates information under section 551 and does not have a primary focus on new uses of drugs or devices that are marketed or under investigation by a manufacturer supporting the dissemination of information; and
(5) presents materials that are not false or misleading.

SEC. 553. [360aaa-2] ESTABLISHMENT OF LIST OF ARTICLES AND PUBLICATIONS DISSEMINATED AND LIST OF PROVIDERS THAT RECEIVED ARTICLES AND REFERENCE PUBLICATIONS.

(a) IN GENERAL. -- A manufacturer may disseminate information under section 551 on a new use only if the manufacturer prepares and submits to the Secretary biannually --

(1) a list containing the titles of the articles and reference publications relating to the new use of drugs or devices that were disseminated by the manufacturer to a person described in section 551(a) for the 6-month period preceding the date on which the manufacturer submits the list to the Secretary; and
(2) a list that identifies the categories of providers (as described in section 551(a)) that received the articles and reference publications for the 6-month period described in paragraph (1).

(b) RECORDS. -- A manufacturer that disseminates information under section 551 shall keep records that may be used by the manufacturer when, pursuant to section 555, such manufacturer is required to take corrective action and shall be made available to the Secretary, upon request, for purposes of ensuring or taking corrective action pursuant to such section. Such records, at the Secretary's discretion, may identify the recipient of information provided pursuant to section 551 or the categories of such recipients.

SEC. 554. [360aaa-3] REQUIREMENT REGARDING SUBMISSION OF SUPPLEMENTAL APPLICATION FOR NEW USE; EXEMPTION FROM REQUIREMENT.

(a) IN GENERAL. -- A manufacturer may disseminate information under section 551 on a new use only if -

(1)(A) the manufacturer has submitted to the Secretary a supplemental application for such use; or
(B) the manufacturer meets the condition described in subsection (b) or (c) (relating to a certification that the manufacturer will submit such an application); or
(2) there is in effect for the manufacturer an exemption under subsection (d) from the requirement of paragraph (1).

(b) CERTIFICATION ON SUPPLEMENTAL APPLICATION; CONDITION IN CASE OF COMPLETED STUDIES. -- For purposes of subsection (a)(l)(B), a manufacturer may disseminate information on a new use if the manufacturer has submitted to the Secretary an application containing a certification that --

(1) the studies needed for the submission of a supplemental application for the new use have been completed; and
(2) the supplemental application will be submitted to the Secretary not later than 6 months after the date of the initial dissemination of information under section 551.

(c) CERTIFICATION ON SUPPLEMENTAL APPLICATION; CONDITION IN CASE OF PLANNED STUDIES. --

(1) IN GENERAL. -- For purposes of subsection (a)(l)(B), a manufacturer may disseminate information on a new use if -

(A) the manufacturer has submitted to the Secretary an application containing --

(i) a proposed protocol and schedule for conducting the studies needed for the submission of a supplemental application for the new use; and
(ii) a certification that the supplemental application will be submitted to the Secretary not later than 36 months after the date of the initial dissemination of information under section 551 (or, as applicable, not later than such date as the Secretary may specify pursuant to an extension under paragraph (3)); and

(B) the Secretary has determined that the proposed protocol is adequate and that the schedule for completing such studies is reasonable.

(2) PROGRESS REPORTS ON STUDIES. -- A manufacturer that submits to the Secretary an application under paragraph (1) shall submit to the Secretary periodic reports describing the status of the studies involved.
(3) EXTENSION OF TIME REGARDING PLANNED STUDIES.-- The period of 36 months authorized in paragraph (1)(A)(ii) for the completion of studies may be extended by the Secretary if -

(A) the Secretary determines that the studies needed to submit such an application cannot be completed and submitted within 36 months; or
(B) the manufacturer involved submits to the Secretary a written request for the extension and the Secretary determines that the manufacturer has acted with due diligence to conduct the studies in a timely manner, except that an extension under this subparagraph may not be provided for more than 24 additional months.

(d) EXEMPTION FROM REQUIREMENT OF SUPPLEMENTAL APPLICATION.--

(1) IN GENERAL. -- For purposes of subsection (a)(2), a manufacturer may disseminate information on a new use if -

(A) the manufacturer has submitted to the Secretary an application for an exemption from meeting the requirement of subsection (a)(1); and
(B)(i) the Secretary has approved the application in accordance with paragraph (2); or
(ii) the application is deemed under paragraph (3)(A) to have been approved (unless such approval is terminated pursuant to paragraph (3)(B)).

(2) CONDITIONS FOR APPROVAL. -- The Secretary may approve an application under paragraph (1) for an exemption if the Secretary makes a determination described in subparagraph (A) or (B), as follows:

(A) The Secretary makes a determination that, for reasons defined by the Secretary, it would be economically prohibitive with respect to such drug or device for the manufacturer to incur the costs necessary for the submission of a supplemental application. In making such determination, the Secretary shall consider (in addition to any other considerations the Secretary finds appropriate) --

(i) the lack of the availability under law of any period during which the manufacturer would have exclusive marketing rights with respect to the new use involved; and
(ii) the size of the population expected to benefit from approval of the supplemental application.

(B) The Secretary makes a determination that, for reasons defined by the Secretary, it would be unethical to conduct the studies necessary for the supplemental application. In making such determination, the Secretary shall consider (in addition to any other considerations the Secretary finds appropriate) whether the new use involved is the standard of medical care for a health condition.

(3) TIME FOR CONSIDERATION OF APPLICATION; DEEMED APPROVAL. --

(A) IN GENERAL. -- The Secretary shall approve or deny an application under paragraph (1) for an exemption not later than 60 days after the receipt of the application. If the Secretary does not comply with the preceding sentence, the application is deemed to be approved.
(B) TERMINATION OF DEEMED APPROVAL. -- If pursuant to a deemed approval under subparagraph (A) a manufacturer disseminates written information under section 551 on a new use, the Secretary may at any time terminate such approval and under section 555(b)(3) order the manufacturer to cease disseminating the information.

(e) REQUIREMENTS REGARDING APPLICATIONS .--Applications under this section shall be submitted in the form and manner prescribed by the Secretary.

SEC. 555. [360aaa-4] CORRECTIVE ACTIONS; CESSATION OF DISSEMINATION.

(a) POSTDISSEMINATION DATA REGARDING SAFETY AND EFFECTIVENESS. --

(1) CORRECTIVE ACTIONS. -- With respect to data received by the Secretary after the dissemination of information under section 551 by a manufacturer has begun (whether received pursuant to paragraph (2) or otherwise), if the Secretary determines that the data indicate that the new use involved may not be effective or may present a significant risk to public health, the Secretary shall, after consultation with the manufacturer, take such action regarding the dissemination of the information as the Secretary determines to be appropriate for the protection of the public health, which may include ordering that the manufacturer cease the dissemination of the information.
(2) RESPONSIBILITIES OF MANUFACTURERS TO SUBMIT DATA. -- After a manufacturer disseminates information under section 551, the manufacturer shall submit to the Secretary a notification of any additional knowledge of the manufacturer on clinical research or other data that relate to the safety or effectiveness of the new use involved. If the manufacturer is in possession of the data, the notification shall include the data. The Secretary shall by regulation establish the scope of the responsibilities of manufacturers under this paragraph, including such limits on the responsibilities as the Secretary determines to be appropriate.

(b) CESSATION OF DISSEMINATION. --

(1) FAILURE OF MANUFACTURER TO COMPLY WITH REQUIREMENTS. -- The Secretary may order a manufacturer to cease the dissemination of information pursuant to section 551 if the Secretary determines that the information being disseminated does not comply with the requirements established in this subchapter. Such an order may be issued only after the Secretary has provided notice to the manufacturer of the intent of the Secretary to issue the order and (unless paragraph (2)(B) applies) has provided an opportunity for a meeting with respect to such intent. If the failure of the manufacturer constitutes a minor violation of this subchapter, the Secretary shall delay issuing the order and provide to the manufacturer an opportunity to correct the violation.
(2) SUPPLEMENTAL APPLICATIONS. -- The Secretary may order a manufacturer to cease the dissemination of information pursuant to section 551 if -

(A) in the case of a manufacturer that has submitted a supplemental application for a new use pursuant to section 554(a)(1), the Secretary determines that the supplemental application does not contain adequate information for approval of the new use for which the application was submitted;
(B) in the case of a manufacturer that has submitted a certification under section 554(b), the manufacturer has not, within the 6-month period involved, submitted the supplemental application referred to in the certification; or
(C) in the case of a manufacturer that has submitted a certification under section 554(c) but has not yet submitted the supplemental application referred to in the certification, the Secretary determines, after an informal hearing, that the manufacturer is not acting with due diligence to complete the studies involved.

(3) TERMINATION OF DEEMED APPROVAL OF EXEMPTION REGARDING SUPPLEMENTAL APPLICATIONS. -- If under section 554(d)(3) the Secretary terminates a deemed approval of an exemption, the Secretary may order the manufacturer involved to cease, disseminating the information. A manufacturer shall comply with an order under the preceding sentence not later than 60 days after the receipt of the order.

(C) CORRECTIVE ACTIONS BY MANUFACTURERS. --

(1) IN GENERAL. -- In any case in which under this section the Secretary orders a manufacturer to cease disseminating information, the Secretary may order the manufacturer to take action to correct the information that has been disseminated, except as provided in paragraph (2).
(2) TERMINATION OF DEEMED APPROVAL OF EXEMPTION REGARDING SUPPLEMENTAL APPLICATIONS. -- In the case of an order under subsection (b)(3) to cease disseminating information, the Secretary may not order the manufacturer involved to take action to correct the information that has been disseminated unless the Secretary determines that the new use described in the information would pose a significant risk to the public health.

SEC. 556. [360aaa-5] DEFINITIONS.

For purposes of this subchapter:

(1) The term "health care practitioner" means a physician, or other individual who is a provider of health care, who is licensed under the law of a State to prescribe drugs or devices.
(2) The terms "health insurance issuer" and "group health plan" have the meaning given such terms under section 2791 of the Public Health Service Act.
(3) The term "manufacturer" means a person who manufactures a drug or device, or who is licensed by such person to distribute or market the drug or device.
(4) The term "new use" --

(A) with respect to a drug, means a use that is not included in the labeling of the approved drug; and
(B) with respect to a device, means a use that is not included in the labeling for the approved or cleared device.

(5) The term "scientific or medical journal" means a scientific or medical publication--

(A) that is published by an organization--

(i) that has an editorial board;
(ii) that utilizes experts, who have demonstrated expertise in the subject of an article under review by the organization and who are independent of the organization, to review and objectively select, reject, or provide comments about proposed articles; and
(iii) that has a publicly stated policy, to which the organization adheres, of full disclosure of any conflict of interest or biases for all authors or contributors involved with the journal or organization;

(B) whose articles are peer-reviewed and published in accordance with the regular peer-review procedures of the organization;
(C) that is generally recognized to be of national scope and reputation;
(D) that is indexed in the Index Medicus of the National Library of Medicine of the National Institutes of Health; and
(E) that is not in the form of a special supplement that has been funded in whole or in part by one or more manufacturers.

SEC. 557. [360aaa-6] RULES OF CONSTRUCTION.

(a) UNSOLICITED REQUEST.--Nothing in section 551 shall be construed as prohibiting a manufacturer from disseminating information in response to an unsolicited request from a health care practitioner.

(b) DISSEMINATION OF INFORMATION ON DRUGS OR DEVICES NOT EVIDENCE OF INTENDED USE. -- Notwithstanding subsection (a), (f), or (o) of section 502, or any other provision of law, the dissemination of information relating to a new use of a drug or device, in accordance with section 551, shall not be construed by the Secretary as evidence of a new intended use of the drug or device that is different from the intended use of the drug or device set forth in the official labeling of the drug or device. Such dissemination shall not be considered by the Secretary as labeling, adulteration, or misbranding of the drug or device.

(c) PATENT PROTECTION. -- Nothing in section 551 shall affect patent rights in any manner.

(d) AUTHORIZATION FOR DISSEMINATION OF ARTICLES AND FEES FOR REPRINTS OF ARTICLES.-- Nothing in section 551 shall be construed as prohibiting an entity that publishes a scientific journal (as defined in section 556(5)) from requiring authorization from the entity to disseminate an article published by such entity or charging fees for the purchase of reprints of published articles from such entity.

¹This subchapter was added by section 401(a) of P.L. 105-115. Subsections (d) and (e) of such section provides the following: (footnote page 244)
(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 (e), whichever is sooner. (footnote page 244)
(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. (footnote page 244)

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