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[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.
```