[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[S. 3546 Introduced in Senate (IS)]








109th CONGRESS
  2d Session
                                S. 3546

   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, and Mr. 
   Kennedy) introduced the following bill; which was read twice and 
  referred to the Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 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,

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.--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.
    ``(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 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.''.
    (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 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.''.
    (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.
                                 <all>