[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[S. 3546 Reported in Senate (RS)]
Calendar No. 586
109th CONGRESS
2d Session
S. 3546
[Report No. 109-324]
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.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
June 21, 2006
Mr. Hatch (for himself, Mr. Durbin, Mr. Harkin, Mr. Enzi, Mr. Kennedy,
and Mr. Cornyn) introduced the following bill; which was read twice and
referred to the Committee on Health, Education, Labor, and Pensions
September 5, 2006
Reported by Mr. Enzi, with an amendment
[Strike out all after the enacting clause and insert the part printed
in italic]
_______________________________________________________________________
A BILL
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,
<DELETED>SECTION 1. SHORT TITLE.</DELETED>
<DELETED> This Act may be cited as the ``Dietary Supplement and
Nonprescription Drug Consumer Protection Act''.</DELETED>
<DELETED>SEC. 2. SERIOUS ADVERSE EVENT REPORTING FOR NONPRESCRIPTION
DRUGS.</DELETED>
<DELETED> (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:</DELETED>
<DELETED>``Subchapter H--Serious Adverse Event Reports</DELETED>
<DELETED>``SEC. 760. SERIOUS ADVERSE EVENT REPORTING FOR
NONPRESCRIPTION DRUGS.</DELETED>
<DELETED> ``(a) Definitions.--In this section:</DELETED>
<DELETED> ``(1) Adverse event.--The term `adverse event'
means any health-related event associated with the use of a
nonprescription drug that is adverse, including--</DELETED>
<DELETED> ``(A) an event occurring from an overdose
of the drug, whether accidental or
intentional;</DELETED>
<DELETED> ``(B) an event occurring from abuse of the
drug;</DELETED>
<DELETED> ``(C) an event occurring from withdrawal
from the drug; and</DELETED>
<DELETED> ``(D) any failure of expected
pharmacological action of the drug.</DELETED>
<DELETED> ``(2) Nonprescription drug.--The term
`nonprescription drug' means a drug that is--</DELETED>
<DELETED> ``(A) not subject to section 503(b);
and</DELETED>
<DELETED> ``(B) not subject to approval in an
application submitted under section 505.</DELETED>
<DELETED> ``(3) Serious adverse event.--The term `serious
adverse event' is an adverse event that--</DELETED>
<DELETED> ``(A) results in--</DELETED>
<DELETED> ``(i) death;</DELETED>
<DELETED> ``(ii) a life-threatening
experience;</DELETED>
<DELETED> ``(iii) inpatient
hospitalization;</DELETED>
<DELETED> ``(iv) a persistent or significant
disability or incapacity; or</DELETED>
<DELETED> ``(v) a congenital anomaly or
birth defect; or</DELETED>
<DELETED> ``(B) requires, based on reasonable
medical judgment, a medical or surgical intervention to
prevent an outcome described under subparagraph
(A).</DELETED>
<DELETED> ``(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).</DELETED>
<DELETED> ``(b) Reporting Requirement.--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.</DELETED>
<DELETED> ``(c) Submission of Reports.--</DELETED>
<DELETED> ``(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).</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(e) Maintenance and Inspection of Records.--</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(2) Records inspection.--</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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--</DELETED>
<DELETED> ``(i) appropriate credentials, as
determined by the Secretary; and</DELETED>
<DELETED> ``(ii) been duly designated by the
Secretary to have access to the records
required under this section.</DELETED>
<DELETED> ``(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--</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(h) Preemption.--</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(2) Effect of section.--</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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--</DELETED>
<DELETED> ``(i) be made publicly available
pursuant to any State or other law requiring
disclosure of information or records;
or</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(i) Authorization of Appropriations.--There are
authorized to be appropriated to carry out this section such sums as
may be necessary.''.</DELETED>
<DELETED> (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.</DELETED>
<DELETED> (c) Prohibited Act.--Section 301(e) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 331(e)) is amended by--</DELETED>
<DELETED> (1) striking ``, or 704(a);'' and inserting ``,
704(a), or 760;''; and</DELETED>
<DELETED> (2) striking ``, or 564'' and inserting ``, 564,
or 760''.</DELETED>
<DELETED> (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:</DELETED>
<DELETED> ``(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 an address or 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.''.</DELETED>
<DELETED> (e) Effective Dates.--</DELETED>
<DELETED> (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.</DELETED>
<DELETED> (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.</DELETED>
<DELETED> (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.</DELETED>
<DELETED>SEC. 3. SERIOUS ADVERSE EVENT REPORTING FOR DIETARY
SUPPLEMENTS.</DELETED>
<DELETED> (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:</DELETED>
<DELETED>``SEC. 761. SERIOUS ADVERSE EVENT REPORTING FOR DIETARY
SUPPLEMENTS.</DELETED>
<DELETED> ``(a) Definitions.--In this section:</DELETED>
<DELETED> ``(1) Adverse event.--The term `adverse event'
means any health-related event associated with the use of a
dietary supplement that is adverse.</DELETED>
<DELETED> ``(2) Serious adverse event.--The term `serious
adverse event' is an adverse event that--</DELETED>
<DELETED> ``(A) results in--</DELETED>
<DELETED> ``(i) death;</DELETED>
<DELETED> ``(ii) a life-threatening
experience;</DELETED>
<DELETED> ``(iii) inpatient
hospitalization;</DELETED>
<DELETED> ``(iv) a persistent or significant
disability or incapacity; or</DELETED>
<DELETED> ``(v) a congenital anomaly or
birth defect; or</DELETED>
<DELETED> ``(B) requires, based on reasonable
medical judgment, a medical or surgical intervention to
prevent an outcome described under subparagraph
(A).</DELETED>
<DELETED> ``(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).</DELETED>
<DELETED> ``(b) Reporting Requirement.--</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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).</DELETED>
<DELETED> ``(c) Submission of Reports.--</DELETED>
<DELETED> ``(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).</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(e) Maintenance and Inspection of Records.--</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(2) Records inspection.--</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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--</DELETED>
<DELETED> ``(i) appropriate credentials, as
determined by the Secretary; and</DELETED>
<DELETED> ``(ii) been duly designated by the
Secretary to have access to the records
required under this section.</DELETED>
<DELETED> ``(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--</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(h) Preemption.--</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(2) Effect of section.--</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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--</DELETED>
<DELETED> ``(i) be made publicly available
pursuant to any State or other law requiring
disclosure of information or records;
or</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(i) Authorization of Appropriations.--There are
authorized to be appropriated to carry out this section such sums as
may be necessary.''.</DELETED>
<DELETED> (b) Prohibited Act.--Section 301(e) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 331(e)) is amended by--</DELETED>
<DELETED> (1) striking ``, or 760;'' and inserting ``, 760,
or 761;''; and</DELETED>
<DELETED> (2) striking ``, or 760'' and inserting ``, 760,
or 761''.</DELETED>
<DELETED> (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:</DELETED>
<DELETED> ``(y) If it is a dietary supplement that is marketed in
the United States, unless the label of such dietary supplement includes
an address or 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.''.</DELETED>
<DELETED> (d) Effective Date.--</DELETED>
<DELETED> (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.</DELETED>
<DELETED> (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.</DELETED>
<DELETED> (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.</DELETED>
<DELETED>SEC. 4. PROHIBITION OF FALSIFICATION OF REPORTS.</DELETED>
<DELETED> (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:</DELETED>
<DELETED> ``(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.''.</DELETED>
<DELETED> (b) Effective Date.--The amendment made by this section
shall take effect 1 year after the date of enactment of this
Act.</DELETED>
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.
Calendar No. 586
109th CONGRESS
2d Session
S. 3546
[Report No. 109-324]
_______________________________________________________________________
A BILL
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.
_______________________________________________________________________
September 5, 2006
Reported with an amendment