[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