[Senate Report 109-110]
[From the U.S. Government Publishing Office]
Calendar No. 177
109th Congress Report
SENATE
1st Session 109-110
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TO AMEND THE FEDERAL FOOD, DRUG, AND COSMETIC ACT TO PROVIDE FOR THE
REGULATION OF ALL CONTACT LENSES AS MEDICAL DEVICES, AND FOR OTHER
PURPOSES
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July 27, 2005.--Ordered to be printed
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Mr. Enzi, from the Committee on Health, Education, Labor, and Pensions,
submitted the following
R E P O R T
[To accompany S. 172]
The Committee on Health, Education, Labor, and Pensions, to
which was referred the bill (S. 172) to amend the Federal Food,
Drug, and Cosmetic Act to provide for the regulation of all
contact lenses as medical devices, and for other purposes,
having considered the same, reports favorably thereon with an
amendment in the nature of a substitute and recommends that the
bill (as amended) do pass.
CONTENTS
Page
I. Purpose and summary..............................................1
II. Background and need for legislation..............................2
III. Legislative history and committee action.........................2
IV. Explanation of bill and committee views..........................2
V. Cost estimate....................................................3
VI. Application of law to the legislative branch.....................4
VII. Regulatory impact statement......................................5
VIII.Section-by-section analysis......................................5
IX. Changes in existing law..........................................5
I. Purpose and Summary of the Bill
The purpose of S.172 is to provide for the regulation of
all contact lenses as medical devices. S. 172 amends Section
520 of the Federal Food, Drug, and Cosmetic Act (FFDCA) by
adding a subsection (n) that deems all contact lenses to be
medical devices under Section 201(h) of the FFDCA.
II. Background and Need for Legislation
``Plano'' contact lenses are zero powered, non-corrective
contact lenses that are used to change the appearance of the
normal eye in a decorative fashion. Most contact lenses
currently marketed in the United States, including certain
plano and decorative contact lenses, have been cleared as
medical devices pursuant to premarket notifications under
Section 510(k) of the FFDCA by the Food and Drug Administration
(FDA). The FDA has asserted medical device jurisdiction over
most corrective and noncorrective contact lenses currently
marketed in the United States, including certain plano and
decorative contact lenses, so as to require approval pursuant
to premarket approval applications under Section 515 of the
FFDCA or clearance pursuant to premarket notifications for
dispensing pursuant to the lawful prescriptions of eye care
professionals.
However, some non-corrective, decorative contact lenses
have not been approved by FDA and are sold without a
prescription. The FDA regulates these non-corrective contact
lenses under its cosmetic authority in Chapter VI of the FFDCA.
These contact lenses present a public health threat.
One such example involved a teenage girl from Cleveland who
bought colored contact lenses from a video rental store for the
purpose of matching her eyes with her dress. The lenses were
sold without fitting or instruction. Shortly after wearing the
colored contact lenses, she was admitted to a Cleveland
hospital where her left eye become so badly infected the doctor
feared that she might not only lose her sight, but she could
actually lose her eye. She was in the intensive care unit for 4
days.
The problem is national in scale. Contact lens insertion
without appropriate supervision and fitting has been linked to
ocular ulcers, as well as temporary and permanent vision
problems. In Wyoming, Dr. Roger Jordan of Gillette reported a
personal experience with a teenager who came in to see him with
vision problems that resulted from an unlicensed person giving
her plano lens that she put over her corrective lenses.
III. Legislative History and Committee Action
On January 26, 2005, Senator DeWine, for himself and
Senator Kennedy, introduced S. 172, to provide for the
regulation of all contact lenses as medical devices. On March
9, 2005, the committee held an executive session to consider S.
172. After accepting an amendment in the nature of a
substitute, the committee approved S. 172, as amended, by
unanimous voice vote.
IV. Explanation of Bill and Committee Views
There is an overwhelming public health consensus that it is
necessary for these products to be regulated as medical
devices. However, because the companies marketing these plano
lenses, mostly importers, have avoided making health claims for
their products, the FDA regulates them as cosmetics, not
medical devices. The committee's action is not intended to
create law for or against FDA's regulatory approach in this
case. S. 172 achieves this result by including a rule of
construction providing that the bill's substantive provision
shall not be construed as having any legal effect on any other
article regulated under the FFDCA.
S. 172 automatically deems all contact lenses to be medical
devices under the Federal Food, Drug, and Cosmetic Act
(``FDCA'') to ensure that all contact lenses are properly
manufactured and used only with the appropriate involvement of
a qualified eye care professional while avoiding any complex
legal or policy issues. In the highly regulated arena of
products governed by the FFDCA, such product-focused
legislation is not unusual. Thus, for example, in 1990,
Congress enacted specific medical device provisions relating to
daily wear soft and nonhydrophilic plastic contact lenses. S.
172 achieves a similar outcome by addressing unanticipated
developments in the marketplace with respect to one particular
form of contact lens.
V. Cost Estimate
U.S. Congress,
Congressional Budget Office,
Washington, DC, April 15, 2005.
Hon. Michael B. Enzi,
Chairman, Committee on Health, Education, Labor, and Pensions,
U.S. Senate, Washington, DC.
Dear Mr. Chairman: The Congressional Budget Office has
prepared the enclosed cost estimate for S. 172, a bill to amend
the Federal Food, Drug, and Cosmetic Act to provide for the
regulation of all contact lenses as medical devices, and for
other purposes.
If you wish further details on this estimate, we will be
pleased to provide them. The CBO staff contact is Julia
Christensen.
Sincerely,
Elizabeth M. Robinson
(For Douglas Holtz-Eakin, Director).
Enclosure
S. 172--A bill to amend the Federal Food, Drug, and Cosmetic Act to
provide for the regulation of all contact lenses as medical
devices, and for other purposes
S. 172 would amend the Federal Food, Drug, and Cosmetic Act
(FDCA) to require that the Food and Drug Administration (FDA)
regulate all contact lens products as medical devices.
FDA currently regulates all contact lenses as medical
devices except for decorative, noncorrective lenses, which FDA
currently regulates as cosmetics. S. 172 would deem all contact
lenses to be medical devices under the FDCA. Based on
information from FDA, CBO expects that the additional cost for
FDA to regulate decorative contact lenses as medical devices
beyond its cost to regulate such products as cosmetics under
current law would be negligible. Assuming the availability of
appropriated amounts, CBO estimates that implementing S. 172
would cost FDA less than $500,000 annually.
CBO expects that changing the regulatory classification of
decorative, non-corrective lenses to medical devices would
likely lead to FDA requiring that those products be available
only by prescription. (For decorative, non-corrective lenses, a
prescription-only label would require the oversight of an eye
care professional to ensure proper fitting and use.) In
response, we anticipate that the Federal Trade Commission (FTC)
would expand its regulation of prescription contact lenses to
include decorative non-corrective contact lenses. Based on
information provided by the FTC, CBO estimates that
implementing S. 172 would not have a significant impact on
spending subject to appropriation for that agency.
The legislation would not affect direct spending. There
would be potential for higher revenues through penalties
imposed by FDA and the FTC for violations of Federal laws under
their respective jurisdictions related to contact lenses. Such
collections of civil penalties are recorded in the budget as
revenues. However, based on information provided by the
agencies, CBO expects that revenues from any penalties
collected as a result of enacting S. 172 would be negligible.
S. 172 contains no intergovernmental mandates as defined in
the Unfunded Mandates Reform act (UMRA) and would impose no
costs on state, local, or tribal governments. However, the bill
would impose private-sector mandates on sellers, prescribers
and manufacturers of decorative non-corrective lenses by making
them subject to more stringent federal regulatory requirements
for medical devices. CBO estimates that the direct costs of the
mandates in the bill would not exceed the threshold established
in UMRA ($123 million in 2005, adjusted annually for inflation)
in any of the first 5 years the mandate would be effective.
A mandate would be imposed on sellers and prescribers
because, as medical devices, such contact lenses would more
likely require prescription verification. CBO expects that
prescribers of decorative, non-corrective lenses would have to
provide the patient with a copy of the prescription and to
verify the prescription to third-party manufacturers. Since eye
care professionals need only return the call of a third-party
manufacturer if the prescription the manufacturer has is wrong,
CBO estimates that the costs to these entities would be
insignificant.
S. 172 also would impose a private-sector mandate on
manufacturers. Based on information from industry and
government sources, CBO estimates that most major manufacturers
already produce decorative, non-corrective contact lenses under
standards that would meet the tighter FDA requirements. For the
remaining manufacturers, CBO estimates that the cost of
upgrading production processes and obtaining FDA approval would
not be significant.
The CBO staff contacts for this estimate are Julia
Christensen and Melissa Zimmerman, for the Federal budget
impact, Leo Lex, for the State and local impact and Meena
Fernandes, for the private-sector impact. This estimate was
approved by Peter H. Fontaine, Deputy Assistant Director for
Budget Analysis.
VI. Application of Law to the Legislative Branch
S. 172 amends Section 520 of the FFDCA to deem all contact
lenses to be medical devices. As such, it has no application to
the legislative branch.
VII. Regulatory Impact Statement
The legislation amends Section 520 of the FFDCA to deem all
contact lenses to be medical devices. Decorative lenses now
regulated as cosmetics would be regulated as medical devices,
requiring that they be available only by prescription and the
oversight of a qualified eye care professional to ensure proper
fitting and use. Accordingly, CBO anticipate S. 172 will result
in a slight increase in cost to the public. CBO anticipates
that the Federal Trade Commission will expand its regulation of
prescription contact lenses to include all decorative, non-
corrective contact lenses. CBO estimates that implementing S.
172 would not have a significant impact on spending subject to
appropriation for that agency. Pursuant to the requirements of
paragraph 11(b) of Rule XXVI of the Standing Rules of the
Senate, the committee has determined that the bill will not
have a significant regulatory impact.
VIII. Section-by-Section Analysis
Sec. 1. Findings
Sec. 2. Regulation of certain articles as medical devices
Section 2 amends Section 520 of the FFDCA by adding a new
subsection (n). Paragraph (1) of the new section 520(n) deems
all contact lenses to be medical devices.
Paragraph (2) of the new section 520(n) makes clear that
paragraph (1) does not have any legal effect on any article
other than a contact lens.
IX. Changes in Existing Law
In compliance with rule XXVI paragraph 12 of the Standing
Rules of the Senate, the following provides a print of the
statute or the part or section thereof to be amended or
replaced (existing law proposed to be omitted is enclosed in
black brackets, new matter is printed in italic, existing law
in which no change is proposed is shown in roman):
FEDERAL FOOD, DRUG, AND COSMETIC ACT
* * * * * * *
GENERAL PROVISIONS RESPECTING CONTROL OF DEVICES INTENDED FOR HUMAN USE
General Rule
Sec. 520. (a) Any requirement authorized by or under
section 501, 502, 510, or 519 applicable to a device intended
for human use shall apply to such device until the
applicability of the requirement to the device has been changed
by action taken under section 513, 514, or 515 or under
subsection (g) of this section, and any requirement established
by or under section 501, 502, 510, or 519 which is inconsistent
with a requirement imposed on such device under section 514 or
515 or under subsection (g) of this section shall not apply to
such device.
* * * * * * *
(m)(1) To the extent consistent with the protection of the
public health and safety and with ethical standards, it is the
purpose of this subsection to encourage the discovery and use
of devices intended to benefit patients in the treatment and
diagnosis of diseases or conditions that affect fewer than
4,000 individuals in the United States.
(2) The Secretary may grant a request for an exemption from
the effectiveness requirements of sections 514 and 515 for a
device for which the Secretary finds that--
(A) * * *
* * * * * * *
Regulation of contact lens as devices
(n)(1) All contact lenses shall be deemed to be devices
under section 201(h).
(2) Paragraph (1) shall not be construed as having any
legal effect on any article that is not subject to such
paragraph.
* * * * * * *