[Congressional Record Volume 152, Number 133 (Wednesday, December 6, 2006)]
[Senate]
[Pages S11376-S11381]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




  DIETARY SUPPLEMENT AND NONPRESCRIPTION DRUG CONSUMER PROTECTION ACT

  Mr. FRIST. Mr. President, I ask unanimous consent that the Senate 
proceed to the immediate consideration of Calendar No. 586, S. 3546.
  The PRESIDING OFFICER. The clerk will report the bill by title.
  The legislative clerk read as follows:


[[Page S11377]]


       A bill (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.

  There being no objection, the Senate proceeded to consider the bill 
which had been reported from the Committee on Health, Education, Labor, 
and Pensions, with an amendment to strike all after the enacting clause 
and insert in lieu thereof the following:

     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).

[[Page S11378]]

       ``(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.

     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.

  Mr. HATCH. Mr. President, the Dietary Supplement and Nonprescription 
Drug Consumer Protection Act represents a too-rare-but-productive 
alliance between Democrats and Republicans and between consumer groups 
and FDA-regulated products manufacturers. This is a significant 
consumer protection measure. On behalf of my cosponsors, Senators 
Durbin, Harkin, Enzi, Kennedy, and Cornyn, I want to express our 
enthusiasm that the bill will be approved by the Senate tonight.
  Senator Durbin, Senator Harkin, and I have been working on this 
legislation for more than 2 years. Our effort has been enhanced by the 
expertise of Chairman Enzi and Senator Kennedy. More recently, we were 
pleased that Senator Cornyn joined our ranks. I must also pay great 
tribute to our lead House sponsor, Representative Chris Cannon.
  We have consulted broadly with all who have an interest in this 
issue--dietary supplement and nonprescription drug manufacturers, 
consumer and public health groups, retailers, wholesalers, and, of 
course, their lawyers! .

[[Page S11379]]

  We have had meeting after meeting with the Food and Drug 
Administration.
  Wherever possible, we have incorporated provisions to address their 
concerns.
  The result--some 24 months and 21 drafts later--is the bill we 
consider tonight.
  Some of my colleagues may ask, ``Why is this bill necessary?'' Let me 
answer that question.
  Over half our population regularly uses dietary supplements. In fact, 
one government survey in 2004 indicated that nearly 60 percent of 
Americans regularly use dietary supplements to maintain or improve 
their healthy lifestyles.
  Millions more use nonprescription or over-the-counter drugs, such as 
aspirin or cold tablets.
  Although the FDA has a voluntary system to receive reports of 
problems with dietary supplements, and a mandatory system that covers 
some OTC drugs, there is no requirement for mandatory reporting for all 
of these products, as there is for prescription drugs and medical 
devices.
  I happen to believe supplements are vastly more safe than 
prescription drugs. Indeed, the law which sets out the regulatory 
framework for supplements--the Dietary Supplement Health and Education 
Act, DSHEA, which Senator Harkin and I authored with then-
Representative Bill Richardson, explicitly treats most supplement 
products as foods. So, I in no way am suggesting that supplement 
products should be treated the same as prescription medications.
  When we enacted DSHEA, we separated supplements into two categories--
those that were on the market in the United States at the time of 
enactment, and those which would be marketed in the future--new dietary 
ingredients''. The presumption of DSHEA, which by and large has worked 
welt, is that products already on the market were being used safely. 
Some of these products, in fact, have been used safely for decades, if 
not millennia.
  Those ``grandfathered'' products are not subject to any kind of 
premarket clearance by the FDA.
  And for good reason.
  The cost and time alone required to see a product through FDA 
approval would sound the death knell for this industry. Most supplement 
products cannot be patented, and there is no incentive for a 
manufacturer to put its product through this costly and onerous process 
when any other manufacturer could benefit equally from the fruits of 
the research and investment.
  Finally, we also authorized the FDA to establish good manufacturing 
practice standards, GMPs, for supplements. Unfortunately, some 12 years 
later, those GMPs are still in the development stage, even though they 
were first finalized by the Clinton administration.
  Senator Harkin and I have spent several years trying to free them up, 
but that is a story for another time.
  So, in essence, grandfathered products are assumed to be safe. But, 
in case some may not be, we inserted in the law a strong safety 
provision and we also added an ``imminent hazard'' authority so that 
FDA can immediately remove from marketing a product it suspects to be 
unsafe, no questions asked.
  In 1994, we had no way of knowing what products would be marketed in 
the future. But to allay any concerns about the safety of new products, 
we required all manufacturers to submit information about new 
ingredients to the FDA before they are marketed. This NDI provision has 
by and large has worked well. It does allow the FDA premarket review 
for new products.
  The reason I mention this is to explain the regulatory framework we 
set up in 1994 to help assure supplements are manufactured and marketed 
safely. We provided the FDA with an arsenal of tools to enforce the 
law. Some they have used, others not.
  Since that time, the industry has grown. By some estimates, it is a 
$20 billion industry today.
  Critics of the industry have decried this growth as a negative 
development, and they have repeatedly said that the industry is 
``unregulated.'' Every time I read that in the paper, or see it on TV, 
I cringe. And I know Senator Harkin does as well. For it is simply 
wrong to suggest the industry is unregulated.
  Indeed, under DSHEA, we set out a legal definition of what could be 
marketed as a dietary supplement. We set out a safety standard that 
products must have to meet. We allowed the FDA to develop good 
manufacturing process standards for supplements, and we have repeatedly 
asked the agency to issue those standards so they can be applied to 
products as they are being manufactured. We clarified what types of 
claims could be made about the products and what could not. We said 
these statements must be truthful and not misleading.
  All of these requirements are set out in the law and are to be 
administered by the regulatory agency, the FDA.
  And while the great, great majority of supplement products are used 
safely, there have been problems with some products. Some of these 
problems relate to manufacturing. Some relate to labeling.
  Critics of supplements attribute any problem which might crop up to 
the fact that the industry is ``unregulated.''
  As I have proven, the industry is indeed regulated. It is just not 
regulated in the same fashion as drugs or devices. And it is worth 
highlighting that this is an industry largely comprised of men and 
women of good will, who want to provide the public with health 
enhancing products.
  Let me hasten to add that we all recognize there are bad actors in 
the supplement industry, those who break the law and mislead consumers. 
They should be subject of swift and sure punishment by the FDA and the 
Federal Trade Commission, FTC. Their products should be removed from 
the marketplace and the full weight of the law should be brought down 
on these bad actors.

  It is no secret that the FDA is a woefully underfunded agency, which 
will be the first to admit that its oversight of the dietary supplement 
industry is hampered by a lack of resources. For several years, Senator 
Harkin and I have worked to rectify that short-coming, and we are 
gratified that our Utah colleague, Senator Bennett, chairman of the 
Agriculture Appropriations Subcommittee, has joined hands with us to 
infuse some badly needed resources into the FDA.
  For those who are new to this body, let me mention that in 1994, the 
Senate agreed not once, but twice, to approve DSHEA by unanimous 
consent. The House also passed this bill by UC. It was not 
controversial.
  Members recognized then, as they should now, that supplements are 
largely safe. But just to make doubly sure there was adequate 
regulation, we provided the FDA with an arsenal of tools to take action 
against problematic products.
  Then comes ephedra.
  I do not think it is a constructive exercise to rehash the history of 
ephedra. There were mistakes and problems all around in how this 
product's safety was evaluated and addressed.
  But something did stand out: one company had literally hundreds, if 
not thousands, of reports about products with this product, none of 
which were revealed to Federal authorities.
  There is no question in my mind that the too-long safety evaluation 
of ephedra would have been shortened considerably had we known earlier 
about these reports.
  Two years ago, I began discussing with those who are interested in 
dietary supplement regulation whether it would be wise to implement a 
system of mandatory adverse event reporting, AER, for those products.
  While I am reluctant to argue for greater government regulation, in 
this case it seemed to me a good case could be made that an AER system 
for supplements could complement the work we achieved with DSHEA and 
improve the government's ability to address the relatively few problems 
which arose.
  Senator Durbin and Senator Harkin were also having similar thoughts.
  We joined forces and after much study, discussion and negotiation, 
produced S. 3546.
  It may be surprising to many of our colleagues that Senators Hatch, 
Durbin, Harkin, Enzi and Kennedy stand together on this legislation--we 
come from very different perspectives on dietary supplement regulation.
  And while we are each very passionate about our views, we are united 
in a common goal: improving the public health.
  The premise for this bill is simple: mandating a system to provide 
the

[[Page S11380]]

government with information about serious adverse events associated 
with the use of two types of FDA-regulated products--dietary 
supplements and over-the-counter drugs--provides Federal authorities 
with a better tool to respond to any problems which might occur. This 
is an important public health initiative, which at the same time 
safeguards access to dietary supplements and over-the-counter drugs.
  There is currently a voluntary reporting system for supplements and 
some OTC drugs our bill would replace that with a mandatory system.
  Senator Harkin and I have a longstanding interest in regulation of 
these products; stemming back to our work on DSHEA.
  Senator Durbin, as the former chair of the House Agriculture 
Appropriations Subcommittee, is one of the most knowledgeable senators 
in this body when it comes to FDA matters.
  Our collaboration on this legislation, along with the distinguished 
chairman and ranking minority member of the committee of jurisdiction, 
the Health, Education, Labor and Pensions Committee, both of whom were 
integral to this process, has produced a bill which strikes the right 
balance between necessary regulation and over-regulation.
  This is how the new system will work:
  Manufacturers, packers or distributors of OTC drugs or dietary 
supplements marketed in the United States must provide to the FDA 
within 15 business days any reports of a serious adverse event 
associated with their products. Accompanying that report must be a copy 
of the label on or within the retail packaging of the supplement.
  The definition of serious event is proscribed within the legislation. 
It is either an event that results in a death, life-threatening 
experience, inpatient hospitalization, persistent or significant 
disability or incapacity, or congenital anomaly or birth defect... or 
it is an event that requires based on reasonable medical judgment a 
medical or surgical intervention to prevent one of the outcomes I have 
just listed.
  The bill requires that those reporting must, for one year, provide 
any new medical information related to the serious adverse event 
report. Again, that information must be submitted within 15 days.
  In addition, manufacturers, packers and distributors must keep for 6 
years records of any adverse event associated with the product, even 
though there is no reporting requirement unless the event meets the 
definition of serious.
  For over-the-counter drugs, the definition of ``adverse event'' is a 
health-related event associated with the use of a nonprescription drug 
that is adverse, including: an event occurring from an overdose, 
whether accidental or intentional; an event occurring from abuse of the 
drug, or withdrawal from the drug; or any failure of pharmacological 
action.
  For dietary supplements, an ``adverse event'' means any health-
related event associated with the use of a dietary supplement that is 
adverse.
  The reports will be submitted on the current MedWatch form, unless 
the Secretary of Health and Human Services chooses to modify that form 
at some point.
  The bill makes clear that State health officials may have access to 
the adverse event reports, but that the Federal reporting system would 
supersede any state reporting laws.
  As we met to develop this legislation, one thing we struggled with 
was the need to encourage responsible reporting in a way that 
manufacturers could implement. Some manufacturers indicated to us, for 
example, that they were not medical experts and could not determine in 
every case if a reporter's problem met the definition of ``serious'' 
contained in the bill.
  To address this, we allow manufacturers to contract with third 
parties to handle the collection of reports. The manufacturers, of 
course, would still be ultimately responsible for reporting.
  Another concern was making certain we appropriately defined the role 
of retailers, who are selling a range of products, some supplements, 
some OTCs, some not. We determined that retailers would not be 
considered reporting parties. If, however, a retailer contracts 
with manufacturers to distribute ``private label'' products, they may 
authorize the manufacturer or packer to submit reports, as long as the 
retailer directors to the manufacturer all reports it receives.

  We also wanted to allow the FDA the flexibility to manage this 
program. At its request, we made the program self-implementing. We also 
included a provision to allow the Secretary, after notice and comment 
from interested parties, to establish an exemption to the reporting 
requirements if there would be no adverse effect on public health.
  Finally, there are provisions in the bill to impose penalties for not 
reporting, not providing on the product label an address or phone 
number for reporting, and for providing a false report.
  The law will go into effect one year after the date of enactment.
  Before I close, I want to address some of the concerns that 
representatives of the dietary supplement industry have voiced with 
this legislation.
  First, some have suggested there is no need for this legislation from 
a public policy or a consumer safety perspective. I disagree.
  Many have unfairly criticized the industry over media reports that 
supplements are unsafe because there is no pre-market approval. While I 
can never support any system that requires premarket approval for 
supplements, I have become convinced that having a system in place to 
identify problems quickly can only enhance the authorities we gave the 
FDA with DSHEA.
  It is also good policy. As the industry matures, we need to separate 
out the good actors from the bad. This is one way to show that this 
industry is a respectable, mainstream industry. Other major industries, 
e.g. pharmaceuticals, devices, are subject to mandatory AER reporting. 
Supplements are only handled through the voluntary reporting system.
  And, I disagree with you those who avow there is no consumer safety 
benefit. Let's take an easy case--where there is a bad batch of a 
product. Enabling the FDA to know quickly there is a problem can help 
industry and the public.
  Other critics note that the FDA fails to pursue egregious violations 
of DSHEA. They question why this program will help. As I discussed 
earlier, Senator Harkin and I have been working to increase FDA's 
funding for responsible enforcement of DSHEA. I have also discussed 
this with the Commissioner-nominee, Dr. Andrew von Eschenbach, whom I 
expect we will confirm tomorrow.
  I listened carefully to one of my constituents who opposes this 
effort. He suggested that the FDA's voluntary system, the CAERS system, 
should be able to handle any reports of problems. Public health experts 
will agree that a voluntary system is not as good a sentinel as a 
mandatory system. In addition, those who report under the voluntary 
system are more likely to be physicians. Encouraging consumers to 
report to manufacturers through a phone number or address on the 
product's label will ensure a more thorough reporting system.
  Yet another concern I have heard is that this bill has a significant 
economic impact that has not been studied appropriately. One estimate I 
have heard is that it could cost tens of millions of dollars a year to 
industry and consumers.
  I have to say that these estimates do not seem to be supported by 
other industry representatives who already are instituting reporting 
systems of their own. During the drafting of this bill, we worked very 
hard to keep requirements to the minimum that would be necessary for a 
complete and full reporting of serious adverse events.
  In addition, I have heard a suggestions that a better alternative to 
this bill would be a 1-800 number that consumers can use to contact FDA 
directly to report complaints. I discussed this idea with my colleagues 
and the FDA and found little support for this idea. What this could do 
is shift onto FDA the majority of reports about product problems. In 
other words, FDA fears that consumers would start phoning the agency, 
rather than the manufacturer, to report complaints for things like 
broken bottles or tablets, or to answer questions about usage. It is 
easy to see how this could end up relieving manufacturers of some of 
their consumer-related responsibilities and shift that onto the FDA.
  Let me hasten to add that I understand the motivation behind these 
concerns. I will keep a close watch on this

[[Page S11381]]

new program as it is implemented, and pledge to reexamine it should 
problems of implementation arise.
  In closing, I want to thank my colleagues for the spirit of 
collaboration which led to development of this legislation. In 
particular, I want to thank Senator Durbin for his leadership on this 
issue. While we may not have always agreed on every provision, we did 
forge a bill on which we can agree. His top-notch staffer, now a 
distinguished professor, Krista Donahue, worked with us every step of 
the way.
  Senator Harkin is a steadfast supporter of the dietary supplement 
industry, and his guidance undoubtedly made this bill a better product. 
We benefitted greatly from the counsel of his legislative director, Pam 
Smith, and before her, Peter Reinecke, his former chief of staff. Peter 
was instrumental in drafting DSHEA as well.
  Senator Enzi and Senator Kennedy, both long-time experts in food and 
drug law, have both been most generous in their time and in moving the 
process forward. Chairman Enzi's FDA expert, Amy Muhlberg, helped guide 
us through this process and was key in our success. Senator Kennedy's 
staffer, David Dorsey, once a top FDA, lawyer, was instrumental in the 
drafting and made countless invaluable suggestions.
  I will take this opportunity to thank my own staff--Patti DeLoatche, 
who always stood for common sense and reason during heated arguments, 
the elusive Bruce Artim, now a top staffer at Eli Lilley, and of 
course, Patricia Knight, who helped draft DSHEA with me as well.
  Finally, we couldn't have done it without Liz King and Stacey Kern-
Scheerer in Legislative Counsel, who patiently produced the 21 drafts 
leading to the bill today.
  I must also note the groups that also support the bill--the 
Consumer's Union, the Center for Science in the Public Interest, the 
Consumer Healthcare Products Association, the Natural Products 
Association, the Council for Responsible Nutrition, the American Herbal 
Products Association, and finally and most importantly, the Utah 
Natural Products Association.
  That these groups, not often united--at least on this subject--can 
rally around our bill today is a testament to good policy, good 
politics, and a surviving bipartisan spirit.
  It is my hope the Senate will give swift approval to this bipartisan 
measure and that the House will shortly thereafter do the same.
  Mr. DURBIN. Mr. President, today, the Senate adopted a bipartisan 
bill that provides the Food and Drug Administration with the tools it 
needs to help monitor the safety of dietary supplements.
  Dietary supplements are safely consumed by millions of Americans 
every day. I myself take a multivitamin every morning. The vast 
majority of these supplements do not result in harm to the consumer.
  Unfortunately, this is not the case for all supplements. Some cause 
dangerous health problems: increased blood pressure, heart attack, 
stroke, seizures and liver failure. Ephedra is the most well-known 
among these.
  Under the Dietary Supplement Heath and Education Act, DSHEA, which 
passed in 1994, supplement manufacturers are not required to prove 
their products are safe or effective before they are marketed: 
supplements are assumed safe until proven unsafe.
  The bill we passed today will help the FDA identify products that may 
be causing harm to consumers.
  In 2000, the FDA contracted with the Institute of Medicine at the 
National Academies of Science to develop a scientific framework for the 
evaluation of dietary supplements under DSHEA.
  IOM's proposals flowed from their first and essential recommendation 
to Congress: Make adverse event reporting mandatory. They asserted that 
``adverse event reports have considerable strength as potential warning 
signals of problems requiring attention, making monitoring by the FDA 
worthwhile.''
  Unfortunately, under current law, reporting is voluntary and it is 
not working. The Office of the Inspector General at the Department of 
Health and Human Services, HHS, estimated in 2001 that less than 1 
percent of all adverse events associated with dietary supplements are 
reported to the FDA.
  My own experience reinforces the need for a mandatory system of 
reporting. Metabolife told the FDA in February of 1999 that, 
``Metabolife has never been made aware of any adverse health events by 
consumers of its products. Metabolife has never received a notice from 
a consumer that any serious adverse health event has occurred because 
of ingestion of Metabolife 356.''
  The Justice Department began investigating the truthfulness of that 
statement and found that Metabolife was holding 16,500 adverse event 
reports, including almost 2,000 significant cardiac, neurological and 
psychiatric reports.
  The Dietary Supplement and Nonprescription Drug Consumer Protection 
Act will prevent this scenario from ever happening again. Manufacturers 
of over-the-counter drugs and dietary supplements will be required to 
send these reports to the FDA.
  I would like to thank Senators Hatch, Harkin, Enzi and Kennedy, who 
have worked with me for the last 3 years on this important issue.
  Mr. FRIST. Mr. President, I ask unanimous consent that the committee-
reported amendment be agreed to, the bill, as amended, be read a third 
time and passed, the motion to reconsider be laid upon the table, and 
that any statements relating to the bill be printed in the Record.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  The committee amendment in the nature of a substitute was agreed to.
  The bill (S. 3546), as amended, was ordered to be engrossed for a 
third reading, was read the third time, and passed.

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