[Congressional Bills 104th Congress]
[From the U.S. Government Publishing Office]
[S. 1197 Introduced in Senate (IS)]







104th CONGRESS
  1st Session
                                S. 1197

  To amend the Federal Food, Drug, and Cosmetic Act to facilitate the 
      dissemination to physicians of scientific information about 
    prescription drug therapies and devices, and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

               August 11 (legislative day, July 10), 1995

Mr. Mack (for himself, Mr. Frist, Mr. D'Amato, Mr. Shelby, Mr. Abraham, 
 Mr. Santorum, Mr. DeWine, and Mr. Faircloth) introduced the following 
 bill; which was read twice and referred to the Committee on Labor and 
                            Human Resources

_______________________________________________________________________

                                 A BILL


 
  To amend the Federal Food, Drug, and Cosmetic Act to facilitate the 
      dissemination to physicians of scientific information about 
    prescription drug therapies and devices, and for other purposes.
    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. FINDINGS.

    Congress finds that--
            (1) fostering and protecting the highest possible standards 
        of health care for the American people require--
                    (A) creative scientific inquiry and information 
                exchanges in the medical sciences and the industries 
                that serve the American people;
                    (B) dissemination and debate of the results of such 
                inquiry within the medical community; and
                    (C) rapid development, testing, marketing approval, 
                and accessibility of state-of-the-art health care 
                products, such as drugs, biologics, and medical 
                devices;
            (2) traditionally, free-flowing information exchanges 
        between health professionals and the producers of health care 
        products, with respect to potentially beneficial new uses of 
        existing products, have been a means to achieve scientific 
        advances and medical breakthroughs;
            (3) such information exchanges have been protected by law, 
        but erroneous interpretation, application, and enforcement of 
        existing law have inhibited and even foreclosed such 
        information exchanges in recent years; and
            (4) it is imperative to the health of the American people 
        to enact legislation to clarify the intent of Congress and the 
        existing state of the law to stimulate and encourage such 
        educational and scientific information exchanges among industry 
        and health care practitioners.

SEC. 2. INFORMATION EXCHANGE AMENDMENTS.

    Chapter III of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355 et seq.) is amended by adding at the end thereof the following new 
sections:

``SEC. 311. DISSEMINATION OF TREATMENT INFORMATION ON DRUGS AND 
              BIOLOGICAL PRODUCTS.

    ``(a) Dissemination of Treatment Information.--
            ``(1) In general.--Notwithstanding sections 301(d), 502(f), 
        505, and 507 and section 351 of the Public Health Service Act 
        (42 U.S.C. 262), and subject to the requirements of paragraph 
        (2) and subsection (b), a person may disseminate to any person 
        that is a health care practitioner or other provider of health 
        care goods or services, a pharmacy benefit manager, a health 
        maintenance organization or other managed health care 
        organization, or a health care insurer or governmental agency, 
        written information, or an oral or written summary of the 
        written information, concerning--
                    ``(A) a treatment use for an investigational new 
                drug or an investigational biological product approved 
                by the Secretary for such treatment use; or
                    ``(B) a use (whether or not such use is contained 
                in the official labeling) of a new drug (including any 
                antibiotic drug) or a biological product for which an 
                approval of an application filed under section 505(b), 
                505(j), or 507, or a product license issued under the 
                Public Health Service Act, is in effect.
            ``(2) Requirements.--A person may disseminate information 
        under paragraph (1)(B) only if--
                    ``(A) the information is an unabridged--
                            ``(i) reprint or copy of a peer-reviewed 
                        article from a scientific or medical journal 
                        that is published by an organization that is 
                        independent of the pharmaceutical industry; or
                            ``(ii) chapter, authored by an expert or 
                        experts in the disease to which the use 
                        relates, from a recognized reference textbook 
                        that is published by an organization that is 
                        independent of the pharmaceutical industry;
                    ``(B) the text of the information has been approved 
                by a continuing medical education accrediting agency 
                that is independent of the pharmaceutical industry as 
                part of a scientific or medical educational program 
                approved by such agency;
                    ``(C) the information relates to a use that is 
                recognized under Federal law for purposes of third-
                party coverage or reimbursement, and--
                            ``(i) the text of the information has been 
                        approved by an organization referred to in such 
                        Federal law; or
                            ``(ii) the information is part of a disease 
                        management program or treatment guideline with 
                        respect to such use; or
                    ``(D) the information is an accurate and truthful 
                summary of the information described in subparagraph 
                (A), (B), or (C).
    ``(b) Disclosure Statement.--In order to afford a full and fair 
evaluation of the information described in subsection (a), a person 
disseminating the information shall include a statement that 
discloses--
            ``(1) if applicable, that the use of a new drug or 
        biological product described in subparagraph (A) or (B) of 
        subsection (a)(1) and the information with respect to the use 
        have not been approved by the Food and Drug Administration;
            ``(2) if applicable, that the information is being 
        disseminated at the expense of the sponsor of the drug or 
        biological product;
            ``(3) if applicable, that one or more authors of the 
        information being disseminated are employees of or consultants 
        to the sponsor of the drug or biological product; and
            ``(4) the official labeling for the drug and biological 
        product, or in the case of a treatment use of an 
        investigational drug or biological product, the investigator 
        brochure and all updates thereof.
    ``(c) Definition.--As used in this section, the term `expense' 
includes financial, in-kind, and other contributions provided for the 
purpose of disseminating the information described in subsection (a).
    ``(d) Special Rule.--In the case of a professional disagreement 
between the Secretary and other qualified experts with respect to the 
application of section 502(a), the Secretary may not use section 502 to 
prohibit the dissemination of information in the types of circumstances 
and under the conditions set forth in subsections (a) and (b).

``SEC. 312. DISSEMINATION OF INFORMATION ON DEVICES.

    ``(a) Dissemination of Information.--Notwithstanding sections 301, 
501(f), 501(i), 502(a), 502(f), and 502(o), or any other provision of 
law, and subject to subsections (b) and (c), a person may disseminate 
to any person that is a health care practitioner or other provider of 
health care goods or services, a pharmacy benefit manager, a health 
maintenance organization or other managed health care organization, or 
a health care insurer or governmental agency, written or oral 
information (including information exchanged at scientific and 
educational meetings, workshops, or demonstrations) relating to a use, 
whether or not the use is described in the official labeling, of a 
device produced by a manufacturer registered pursuant to section 510.
    ``(b) Disclosure Statements and Requirements.--
            ``(1) Disclosure statements.--To the extent practicable, 
        the requirement with respect to a statement of disclosure under 
        subsection (b) of section 311 shall apply to the dissemination 
        of written and oral information under this section, except that 
        this paragraph shall not apply to the dissemination of written 
        or oral information with respect to the intended use described 
        in the labeling of a device.
            ``(2) Additional requirements.--A person may disseminate 
        information under subsection (a) only if--
                    ``(A) the information is an unabridged--
                            ``(i) reprint or copy of a peer-reviewed 
                        article from a scientific or medical journal 
                        that is published by an organization that is 
                        independent of the medical device industry; or
                            ``(ii) chapter, authored by an expert or 
                        experts in the medical specialty to which the 
                        use relates, from a recognized reference 
                        textbook that is published by an organization 
                        that is independent of the medical device 
                        industry;
                    ``(B) the information has been approved by a 
                continuing medical education accrediting agency that is 
                independent of the medical device industry as part of a 
                scientific or medical educational program approved by 
                such agency;
                    ``(C) the information relates to a use that is 
                recognized under Federal law for purposes of third-
                party reimbursement, and--
                            ``(i) the text of the information has been 
                        approved by an organization referred to in such 
                        Federal law; or
                            ``(ii) the information is part of a disease 
                        management program or treatment guideline with 
                        respect to such use; or
                    ``(D) the oral or written information is--
                            ``(i) part of an exchange of information 
                        solely among health care practitioners, health 
                        care reimbursement officials, and the industry;
                            ``(ii) exchanged for educational or 
                        scientific purposes; and
                            ``(iii) presented at continuing medical 
                        education programs, seminars, workshops, or 
                        demonstrations.
            ``(3) Applicability.--The requirements under subsection 
        (a)(1)(A) and (B) of section 311 shall not apply with respect 
        to devices.
    ``(c) Information Dissemination Not Evidence of Intended Use.--
Notwithstanding section 502(a), 502(f), 502(o), or any other provision 
of law, the written or oral dissemination of information relating to a 
new use of a device, in accordance with this section, shall not be 
construed by the Secretary as evidence of a new intended use of the 
device that is different from the intended use of the device set forth 
on the official labeling of the device. Such dissemination shall not be 
considered by the Secretary as labeling, adulteration, or misbranding 
of the device.''.

SEC. 3. PRESERVATION OF CURRENT POLICY.

    Nothing in this Act or the amendment made by this Act shall affect 
the ability of manufacturers to respond fully to unsolicited questions 
from health care practitioners and other persons about drugs, 
biological products, or devices.
                                 <all>