[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[S. 3546 Enrolled Bill (ENR)]
S.3546
One Hundred Ninth Congress
of the
United States of America
AT THE SECOND SESSION
Begun and held at the City of Washington on Tuesday,
the third day of January, two thousand and six
An Act
To amend the Federal Food, Drug, and Cosmetic Act with respect to
serious adverse event reporting for dietary supplements and
nonprescription drugs, 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 ``Dietary Supplement and
Nonprescription Drug Consumer Protection Act''.
SEC. 2. SERIOUS ADVERSE EVENT REPORTING FOR NONPRESCRIPTION DRUGS.
(a) In General.--Chapter VII of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 371 et seq.) is amended by adding at the end
the following:
``Subchapter H--Serious Adverse Event Reports
``SEC. 760. SERIOUS ADVERSE EVENT REPORTING FOR NONPRESCRIPTION DRUGS.
``(a) Definitions.--In this section:
``(1) Adverse event.--The term `adverse event' means any
health-related event associated with the use of a nonprescription
drug that is adverse, including--
``(A) an event occurring from an overdose of the drug,
whether accidental or intentional;
``(B) an event occurring from abuse of the drug;
``(C) an event occurring from withdrawal from the drug; and
``(D) any failure of expected pharmacological action of the
drug.
``(2) Nonprescription drug.--The term `nonprescription drug'
means a drug that is--
``(A) not subject to section 503(b); and
``(B) not subject to approval in an application submitted
under section 505.
``(3) Serious adverse event.--The term `serious adverse event'
is an adverse event that--
``(A) results in--
``(i) death;
``(ii) a life-threatening experience;
``(iii) inpatient hospitalization;
``(iv) a persistent or significant disability or
incapacity; or
``(v) a congenital anomaly or birth defect; or
``(B) requires, based on reasonable medical judgment, a
medical or surgical intervention to prevent an outcome
described under subparagraph (A).
``(4) Serious adverse event report.--The term `serious adverse
event report' means a report that is required to be submitted to
the Secretary under subsection (b).
``(b) Reporting Requirement.--
``(1) In general.--The manufacturer, packer, or distributor
whose name (pursuant to section 502(b)(1)) appears on the label of
a nonprescription drug marketed in the United States (referred to
in this section as the `responsible person') shall submit to the
Secretary any report received of a serious adverse event associated
with such drug when used in the United States, accompanied by a
copy of the label on or within the retail package of such drug.
``(2) Retailer.--A retailer whose name appears on the label
described in paragraph (1) as a distributor may, by agreement,
authorize the manufacturer or packer of the nonprescription drug to
submit the required reports for such drugs to the Secretary so long
as the retailer directs to the manufacturer or packer all adverse
events associated with such drug that are reported to the retailer
through the address or telephone number described in section
502(x).
``(c) Submission of Reports.--
``(1) Timing of reports.--The responsible person shall submit
to the Secretary a serious adverse event report no later than 15
business days after the report is received through the address or
phone number described in section 502(x).
``(2) New medical information.--The responsible person shall
submit to the Secretary any new medical information, related to a
submitted serious adverse event report that is received by the
responsible person within 1 year of the initial report, no later
than 15 business days after the new information is received by the
responsible person.
``(3) Consolidation of reports.--The Secretary shall develop
systems to ensure that duplicate reports of, and new medical
information related to, a serious adverse event shall be
consolidated into a single report.
``(4) Exemption.--The Secretary, after providing notice and an
opportunity for comment from interested parties, may establish an
exemption to the requirements under paragraphs (1) and (2) if the
Secretary determines that such exemption would have no adverse
effect on public health.
``(d) Contents of Reports.--Each serious adverse event report under
this section shall be submitted to the Secretary using the MedWatch
form, which may be modified by the Secretary for nonprescription drugs,
and may be accompanied by additional information.
``(e) Maintenance and Inspection of Records.--
``(1) Maintenance.--The responsible person shall maintain
records related to each report of an adverse event received by the
responsible person for a period of 6 years.
``(2) Records inspection.--
``(A) In general.--The responsible person shall permit an
authorized person to have access to records required to be
maintained under this section, during an inspection pursuant to
section 704.
``(B) Authorized person.--For purposes of this paragraph,
the term `authorized person' means an officer or employee of
the Department of Health and Human Services who has--
``(i) appropriate credentials, as determined by the
Secretary; and
``(ii) been duly designated by the Secretary to have
access to the records required under this section.
``(f) Protected Information.--A serious adverse event report
submitted to the Secretary under this section, including any new
medical information submitted under subsection (c)(2), or an adverse
event report voluntarily submitted to the Secretary shall be considered
to be--
``(1) a safety report under section 756 and may be accompanied
by a statement, which shall be a part of any report that is
released for public disclosure, that denies that the report or the
records constitute an admission that the product involved caused or
contributed to the adverse event; and
``(2) a record about an individual under section 552a of title
5, United States Code (commonly referred to as the `Privacy Act of
1974') and a medical or similar file the disclosure of which would
constitute a violation of section 552 of such title 5 (commonly
referred to as the `Freedom of Information Act'), and shall not be
publicly disclosed unless all personally identifiable information
is redacted.
``(g) Rule of Construction.--The submission of any adverse event
report in compliance with this section shall not be construed as an
admission that the nonprescription drug involved caused or contributed
to the adverse event.
``(h) Preemption.--
``(1) In general.--No State or local government shall establish
or continue in effect any law, regulation, order, or other
requirement, related to a mandatory system for adverse event
reports for nonprescription drugs, that is different from, in
addition to, or otherwise not identical to, this section.
``(2) Effect of section.--
``(A) In general.--Nothing in this section shall affect the
authority of the Secretary to provide adverse event reports and
information to any health, food, or drug officer or employee of
any State, territory, or political subdivision of a State or
territory, under a memorandum of understanding between the
Secretary and such State, territory, or political subdivision.
``(B) Personally-identifiable information.--Notwithstanding
any other provision of law, personally-identifiable information
in adverse event reports provided by the Secretary to any
health, food, or drug officer or employee of any State,
territory, or political subdivision of a State or territory,
shall not--
``(i) be made publicly available pursuant to any State
or other law requiring disclosure of information or
records; or
``(ii) otherwise be disclosed or distributed to any
party without the written consent of the Secretary and the
person submitting such information to the Secretary.
``(C) Use of safety reports.--Nothing in this section shall
permit a State, territory, or political subdivision of a State
or territory, to use any safety report received from the
Secretary in a manner inconsistent with subsection (g) or
section 756.
``(i) Authorization of Appropriations.--There are authorized to be
appropriated to carry out this section such sums as may be
necessary.''.
(b) Modifications.--The Secretary of Health and Human Services may
modify requirements under the amendments made by this section in
accordance with section 553 of title 5, United States Code, to maintain
consistency with international harmonization efforts over time.
(c) Prohibited Act.--Section 301(e) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331(e)) is amended by--
(1) striking ``, or 704(a);'' and inserting ``, 704(a), or
760;''; and
(2) striking ``, or 564'' and inserting ``, 564, or 760''.
(d) Misbranding.--Section 502 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 352) is amended by adding at the end the
following:
``(x) If it is a nonprescription drug (as defined in section 760)
that is marketed in the United States, unless the label of such drug
includes a domestic address or domestic phone number through which the
responsible person (as described in section 760) may receive a report
of a serious adverse event (as defined in section 760) with such
drug.''.
(e) Effective Dates.--
(1) In general.--Except as provided in paragraph (2), the
amendments made by this section shall take effect 1 year after the
date of enactment of this Act.
(2) Misbranding.--Section 502(x) of the Federal Food, Drug, and
Cosmetic Act (as added by this section) shall apply to any
nonprescription drug (as defined in such section 502(x)) labeled on
or after the date that is 1 year after the date of enactment of
this Act.
(3) Guidance.--Not later than 270 days after the date of
enactment of this Act, the Secretary of Health and Human Services
shall issue guidance on the minimum data elements that should be
included in a serious adverse event report described under the
amendments made by this Act.
SEC. 3. SERIOUS ADVERSE EVENT REPORTING FOR DIETARY SUPPLEMENTS.
(a) In General.--Chapter VII of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 371 et seq.) is amended by adding at the end
the following:
``SEC. 761. SERIOUS ADVERSE EVENT REPORTING FOR DIETARY SUPPLEMENTS.
``(a) Definitions.--In this section:
``(1) Adverse event.--The term `adverse event' means any
health-related event associated with the use of a dietary
supplement that is adverse.
``(2) Serious adverse event.--The term `serious adverse event'
is an adverse event that--
``(A) results in--
``(i) death;
``(ii) a life-threatening experience;
``(iii) inpatient hospitalization;
``(iv) a persistent or significant disability or
incapacity; or
``(v) a congenital anomaly or birth defect; or
``(B) requires, based on reasonable medical judgment, a
medical or surgical intervention to prevent an outcome
described under subparagraph (A).
``(3) Serious adverse event report.--The term `serious adverse
event report' means a report that is required to be submitted to
the Secretary under subsection (b).
``(b) Reporting Requirement.--
``(1) In general.--The manufacturer, packer, or distributor of
a dietary supplement whose name (pursuant to section 403(e)(1))
appears on the label of a dietary supplement marketed in the United
States (referred to in this section as the `responsible person')
shall submit to the Secretary any report received of a serious
adverse event associated with such dietary supplement when used in
the United States, accompanied by a copy of the label on or within
the retail packaging of such dietary supplement.
``(2) Retailer.--A retailer whose name appears on the label
described in paragraph (1) as a distributor may, by agreement,
authorize the manufacturer or packer of the dietary supplement to
submit the required reports for such dietary supplements to the
Secretary so long as the retailer directs to the manufacturer or
packer all adverse events associated with such dietary supplement
that are reported to the retailer through the address or telephone
number described in section 403(y).
``(c) Submission of Reports.--
``(1) Timing of reports.--The responsible person shall submit
to the Secretary a serious adverse event report no later than 15
business days after the report is received through the address or
phone number described in section 403(y).
``(2) New medical information.--The responsible person shall
submit to the Secretary any new medical information, related to a
submitted serious adverse event report that is received by the
responsible person within 1 year of the initial report, no later
than 15 business days after the new information is received by the
responsible person.
``(3) Consolidation of reports.--The Secretary shall develop
systems to ensure that duplicate reports of, and new medical
information related to, a serious adverse event shall be
consolidated into a single report.
``(4) Exemption.--The Secretary, after providing notice and an
opportunity for comment from interested parties, may establish an
exemption to the requirements under paragraphs (1) and (2) if the
Secretary determines that such exemption would have no adverse
effect on public health.
``(d) Contents of Reports.--Each serious adverse event report under
this section shall be submitted to the Secretary using the MedWatch
form, which may be modified by the Secretary for dietary supplements,
and may be accompanied by additional information.
``(e) Maintenance and Inspection of Records.--
``(1) Maintenance.--The responsible person shall maintain
records related to each report of an adverse event received by the
responsible person for a period of 6 years.
``(2) Records inspection.--
``(A) In general.--The responsible person shall permit an
authorized person to have access to records required to be
maintained under this section during an inspection pursuant to
section 704.
``(B) Authorized person.--For purposes of this paragraph,
the term `authorized person' means an officer or employee of
the Department of Health and Human Services, who has--
``(i) appropriate credentials, as determined by the
Secretary; and
``(ii) been duly designated by the Secretary to have
access to the records required under this section.
``(f) Protected Information.--A serious adverse event report
submitted to the Secretary under this section, including any new
medical information submitted under subsection (c)(2), or an adverse
event report voluntarily submitted to the Secretary shall be considered
to be--
``(1) a safety report under section 756 and may be accompanied
by a statement, which shall be a part of any report that is
released for public disclosure, that denies that the report or the
records constitute an admission that the product involved caused or
contributed to the adverse event; and
``(2) a record about an individual under section 552a of title
5, United States Code (commonly referred to as the `Privacy Act of
1974') and a medical or similar file the disclosure of which would
constitute a violation of section 552 of such title 5 (commonly
referred to as the `Freedom of Information Act'), and shall not be
publicly disclosed unless all personally identifiable information
is redacted.
``(g) Rule of Construction.--The submission of any adverse event
report in compliance with this section shall not be construed as an
admission that the dietary supplement involved caused or contributed to
the adverse event.
``(h) Preemption.--
``(1) In general.--No State or local government shall establish
or continue in effect any law, regulation, order, or other
requirement, related to a mandatory system for adverse event
reports for dietary supplements, that is different from, in
addition to, or otherwise not identical to, this section.
``(2) Effect of section.--
``(A) In general.--Nothing in this section shall affect the
authority of the Secretary to provide adverse event reports and
information to any health, food, or drug officer or employee of
any State, territory, or political subdivision of a State or
territory, under a memorandum of understanding between the
Secretary and such State, territory, or political subdivision.
``(B) Personally-identifiable information.--Notwithstanding
any other provision of law, personally-identifiable information
in adverse event reports provided by the Secretary to any
health, food, or drug officer or employee of any State,
territory, or political subdivision of a State or territory,
shall not--
``(i) be made publicly available pursuant to any State
or other law requiring disclosure of information or
records; or
``(ii) otherwise be disclosed or distributed to any
party without the written consent of the Secretary and the
person submitting such information to the Secretary.
``(C) Use of safety reports.--Nothing in this section shall
permit a State, territory, or political subdivision of a State
or territory, to use any safety report received from the
Secretary in a manner inconsistent with subsection (g) or
section 756.
``(i) Authorization of Appropriations.--There are authorized to be
appropriated to carry out this section such sums as may be
necessary.''.
(b) Prohibited Act.--Section 301(e) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331(e)) is amended by--
(1) striking ``, or 760;'' and inserting ``, 760, or 761;'';
and
(2) striking ``, or 760'' and inserting ``, 760, or 761''.
(c) Misbranding.--Section 403 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 343) is amended by adding at the end the
following:
``(y) If it is a dietary supplement that is marketed in the United
States, unless the label of such dietary supplement includes a domestic
address or domestic phone number through which the responsible person
(as described in section 761) may receive a report of a serious adverse
event with such dietary supplement.''.
(d) Effective Date.--
(1) In general.--Except as provided in paragraph (2), the
amendments made by this section shall take effect 1 year after the
date of enactment of this Act.
(2) Misbranding.--Section 403(y) of the Federal Food, Drug, and
Cosmetic Act (as added by this section) shall apply to any dietary
supplement labeled on or after the date that is 1 year after the
date of enactment of this Act.
(3) Guidance.--Not later than 270 days after the date of
enactment of this Act, the Secretary of Health and Human Services
shall issue guidance on the minimum data elements that should be
included in a serious adverse event report as described under the
amendments made by this Act.
SEC. 4. PROHIBITION OF FALSIFICATION OF REPORTS.
(a) In General.--Section 301 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331) is amended by adding at the end the
following:
``(ii) The falsification of a report of a serious adverse event
submitted to a responsible person (as defined under section 760 or 761)
or the falsification of a serious adverse event report (as defined
under section 760 or 761) submitted to the Secretary.''.
(b) Effective Date.--The amendment made by this section shall take
effect 1 year after the date of enactment of this Act.
SEC. 5. IMPORTATION OF CERTAIN NONPRESCRIPTION DRUGS AND DIETARY
SUPPLEMENTS.
(a) In General.--Section 801 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 381) is amended--
(1) in subsection (a), by inserting after the third sentence
the following: ``If such article is subject to a requirement under
section 760 or 761 and if the Secretary has credible evidence or
information indicating that the responsible person (as defined in
such section 760 or 761) has not complied with a requirement of
such section 760 or 761 with respect to any such article, or has
not allowed access to records described in such section 760 or 761,
then such article shall be refused admission, except as provided in
subsection (b) of this section.''; and
(2) in the second sentence of subsection (b)--
(A) by inserting ``(1)'' before ``an article included'';
(B) by inserting before ``final determination'' the
following: ``or (2) with respect to an article included within
the provision of the fourth sentence of subsection (a), the
responsible person (as defined in section 760 or 761) can take
action that would assure that the responsible person is in
compliance with section 760 or 761, as the case may be,''; and
(C) by inserting ``, or, with respect to clause (2), the
responsible person,'' before ``to perform''.
(b) Effective Date.--The amendments made by this section shall take
effect 1 year after the date of enactment of this Act.
Speaker of the House of Representatives.
Vice President of the United States and
President of the Senate.