[Senate Report 109-110]
[From the U.S. Government Publishing Office]



                                                       Calendar No. 177
109th Congress                                                   Report
                                 SENATE
 1st Session                                                    109-110

======================================================================
 
 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

                                _______
                                

                 July 27, 2005.--Ordered to be printed

                                _______
                                

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.

           *       *       *       *       *       *       *


                                  
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