[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6151 Introduced in House (IH)]
110th CONGRESS
2d Session
H. R. 6151
To amend the Federal Food, Drug, and Cosmetic Act with respect to drug
and device advertising, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
May 22, 2008
Ms. DeLauro (for herself and Mrs. Emerson) introduced the following
bill; which was referred to the Committee on Energy and Commerce
_______________________________________________________________________
A BILL
To amend the Federal Food, Drug, and Cosmetic Act with respect to drug
and device advertising, 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. SHORT TITLE.
This Act may be cited as the ``Responsibility in Drug and Device
Advertising Act of 2008''.
SEC. 2. DIRECT-TO-CONSUMER DRUG OR DEVICE ADVERTISING.
(a) In General.--The Federal Food, Drug, and Cosmetic Act (21
U.S.C. 301 et seq.) is amended--
(1) in section 301, by adding at the end the following:
``(oo) The conduct of direct-to-consumer advertising of a drug or
device in violation of section 503C.''; and
(2) in chapter V, by inserting after section 503B the
following:
``SEC. 503C. DIRECT-TO-CONSUMER DRUG OR DEVICE ADVERTISING.
``(a) Prohibitions.--
``(1) First three years.--
``(A) In general.--Subject to subparagraph (B), no
person shall conduct direct-to-consumer advertising
of--
``(i) a drug for which an application is
submitted under section 505(b) before the end
of the 3-year period beginning on the date of
the approval of such application; or
``(ii) a class II or class III device for
which a premarket notification is submitted
under section 510(k) or a class III device for
which a premarket approval is sought under
section 515, before the end of the 3-year
period beginning on the date of the
notification or approval, respectively.
``(B) Waiver.--The Secretary may waive the
application of subparagraph (A) to a drug or device
during the third year of the 3-year period described in
such subparagraph if--
``(i) the sponsor of the drug or device
submits an application to the Secretary
pursuant to subparagraph (C); and
``(ii) the Secretary, after considering the
application and any accompanying materials,
determines that direct-to-consumer advertising
of the drug or device would have an affirmative
value to public health.
``(C) Application for waiver.--To seek a waiver
under subparagraph (B), the sponsor of a drug or device
shall submit an application to the Secretary at such
time, in such manner, and containing such information
as the Secretary may require.
``(2) Subsequent years.--
``(A) Extension of prohibition.--The Secretary may
prohibit direct-to-consumer advertising of a drug or a
class II or class III device during the period
beginning at the end of the 3-year period described in
paragraph (1)(A) if the Secretary determines that the
drug or device has significant adverse health effects
based on post-approval studies, risk-benefit analyses,
adverse event reports, the scientific literature, any
clinical or observational studies, or any other
appropriate resource.
``(B) Fair balance of benefits and risks for drugs
and devices for permitted dtc advertising.--Any direct-
to-consumer advertising of a drug or a class II or
class III device permitted under this section shall
include a fair balance, as supported by the evidence,
of the benefits and the risks associated with the drug
or device.
``(b) Regulations.--Not later than 1 year after the date of the
enactment of this section, the Secretary shall revise the regulations
promulgated under this Act governing advertisements of drugs and
devices to the extent necessary to implement this section.
``(c) Rule of Construction.--This section shall not be construed to
diminish the authority of the Secretary to prohibit or regulate direct-
to-consumer advertising of drugs or devices under other provisions of
law.''.
(b) Effective Date.--The amendments made by subsection (a) apply
only with respect to a drug for which an application is approved under
section 505(b) of the Federal Food, Drug, and Cosmetic Act, a class II
or class III device for which a notification is submitted under section
510(k) of such Act, or a class III device for which an application is
approved under section 515 of such Act, on or after the date that is 1
year before the date of the enactment of this Act.
SEC. 3. PROMINENT DISPLAY OF INFORMATION IN ADVERTISING ON SIDE
EFFECTS, CONTRAINDICATIONS, AND EFFECTIVENESS.
(a) Requirement for Drugs.--
(1) In general.--Subparagraph (3) of section 502(n) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352(n)) is
amended--
(A) by striking ``such other information'' and all
that follows through ``which shall be issued by'' and
inserting ``such other information in brief summary
relating to side effects, contraindications, and
effectiveness as shall be required in regulations which
shall require such information to be prominently
displayed in terms of font size and location and shall
be issued by'';
(B) by striking ``in the case of published direct-
to-consumer advertisements'' and inserting ``in the
case of direct-to-consumer advertisements (including an
advertisement that accompanies video programming
delivered by television broadcasting or by a
multichannel video programming distributor (as defined
in section 602 of the Communications Act of 1934))'';
and
(C) by striking ``published after the effective
date'' and inserting ``disseminated after the effective
date''.
(2) Discontinuance of study.--The Secretary of Health and
Human Services shall discontinue the study required by section
906(b) of the Food and Drug Administration Amendments Act of
2007 (Public Law 110-85).
(b) Application of Similar Rules for Devices.--The first sentence
of section 502(r) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 352(r)) is amended--
(1) by striking ``(1) a true statement'' and inserting ``a
true statement (1)'';
(2) by striking ``a brief statement''; and
(3) by inserting before the period at the end the
following: ``, and in the case of direct-to-consumer
advertisements (including an advertisement that accompanies
video programming delivered by television broadcasting or by a
multichannel video programming distributor (as defined in
section 602 of the Communications Act of 1934)) the following
statement printed in conspicuous text: `You are encouraged to
report negative side effects of medical devices to the FDA.
Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.'''.
(c) Effective Date.--The amendments made by this section apply with
respect to any advertisement or other descriptive printed matter that
is issued or caused to be issued on or after the date that is 90 days
after the date of the enactment of this Act. Not later than 90 days
after the date of the enactment of this Act, the Secretary shall revise
any regulations promulgated pursuant to subsections (n) and (r) of
section 502 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352)
to the extent necessary to implement this section.
SEC. 4. CIVIL PENALTY.
Subsection (g) of section 303 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 333) is amended to read as follows:
``(g) Drug or Device Advertising and Promotion.--
``(1) Civil penalty.--
``(A) In general.--Any manufacturer, packer, or
distributor of a drug or device who violates section
505(n), section 503C, or any other requirement of this
Act relating to the advertising or promotion of the
drug or device shall be subject to a civil penalty in
an amount not to exceed--
``(i) in the case of the first such
violation by the manufacturer, packer, or
distributor relating to the drug or device,
$1,000,000; and
``(ii) in the case of each subsequent
violation by the manufacturer, packer, or
distributor relating to the drug or device, an
amount that is twice the amount of the maximum
civil penalty applicable under this
subparagraph to the previous violation.
``(B) Procedure.--Paragraphs (3) through (5) of
subsection (f) shall apply with respect to a civil
penalty under subparagraph (A) to the same extent and
in the same manner as those paragraphs apply with
respect to a civil penalty under paragraph (1), (2),
(3), or (4) of subsection (f).
``(2) Distribution of materials.--If the Secretary finds
that a person committed a violation described in paragraph
(1)(A), the Secretary may order the person to distribute
materials in the same markets in which the violative
advertisement or promotional material was distributed in a
manner designed to notify the public and the medical community
of the violation and to provide corrective information.
``(3) Separate offense.--For purposes of imposing a civil
penalty under this subsection, each violation described in
paragraph (1)(A), including each distribution of a direct-to-
consumer advertisement in violation of section 503C, shall
constitute a separate offense.
``(4) Relation to other penalties.--A civil penalty under
paragraph (1) and an order under paragraph (2) shall be in
addition to any other penalty applicable under this Act or
other law to the violation involved.''.
SEC. 5. PUBLIC EDUCATION CAMPAIGN ON RISKS OF CERTAIN DRUGS AND
DEVICES.
The Secretary of Health and Human Services shall conduct an
education campaign to increase public awareness of risks that, for some
patients, may outweigh the benefits of using a particular drug or
device, whether such risks are known at the time of the approval of the
drug or device or become known after the approval of the drug or
device.
SEC. 6. ADDITIONAL FUNDING FOR REGULATION OF DIRECT-TO-CONSUMER DRUG
AND DEVICE ADVERTISING.
There are authorized to be appropriated to the Food and Drug
Administration such sums as may be necessary for each of fiscal years
2009 and 2010 for the purpose of regulating direct-to-consumer drug and
device advertisements, including by carrying out the amendments made by
section 2. The authorization of appropriations in the preceding
sentence is in addition to any other authorization of appropriations
for such purpose.
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