[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
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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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