[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>