[Congressional Record Volume 149, Number 168 (Wednesday, November 19, 2003)]
[House]
[Pages H11565-H11567]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
REGULATION OF NONCORRECTIVE CONTACT LENS AS MEDICAL DEVICES
Mr. BILIRAKIS. Mr. Speaker, I move to suspend the rules and pass the
bill (H.R. 2218) to amend the Federal Food, Drug, and Cosmetic Act to
provide for the regulation of noncorrective contact lens as medical
devices, and for other purposes.
The Clerk read as follows:
H.R. 2218
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. FINDINGS.
The Congress finds as follows:
(1) All contact lenses have significant effects on the eye
and pose serious potential health risks if improperly
manufactured or used without appropriate involvement of a
qualified eye care professional.
(2) Most contact lenses currently marketed in the United
States, including certain plano and decorative contact
lenses, have been approved as medical devices pursuant to
premarket approval applications or cleared pursuant to
premarket notifications by the Food and Drug Administration
(``FDA'').
(3) FDA has asserted medical device jurisdiction over most
corrective and noncorrective contact lenses as medical
devices currently marketed in the United States, including
certain plano and decorative contact lenses, so as to require
approval pursuant to premarket approval applications or
clearance pursuant to premarket notifications.
(4) All contact lenses can present risks if used without
the supervision of a qualified eye care professional. Eye
injuries in children and other consumers have been reported
for contact lenses that are regulated by FDA as medical
devices primarily when used without professional involvement,
and noncorrective contact lenses sold without approval or
clearance as medical devices have caused eye injuries in
children.
SEC. 2. REGULATION OF CERTAIN ARTICLES AS MEDICAL DEVICES.
Section 520 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360j) is amended by adding at the end the following
subsection:
``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 described in that
paragraph.''.
The SPEAKER pro tempore. Pursuant to the rule, the gentleman from
Florida (Mr. Bilirakis) and the gentleman from Ohio (Mr. Brown) each
will control 20 minutes.
The Chair recognizes the gentleman from Florida (Mr. Bilirakis).
General Leave
Mr. BILIRAKIS. Mr. Speaker, I ask unanimous consent that all Members
may have 5 legislative days within which to revise and extend their
remarks and to include extraneous material on H.R. 2218, the bill now
under consideration.
The SPEAKER pro tempore. Is there objection to the request of the
gentleman from Florida?
There was no objection.
{time} 1515
Mr. BILIRAKIS. Mr. Speaker, I yield myself such time as I may
consume.
Mr. Speaker, I rise today in support of H.R. 2218, which amends the
Federal Food, Drug and Cosmetic Act to provide for the regulation of
noncorrective contact lens as medical devices, and I commend the
gentleman from Arkansas (Mr. Boozman) for his work on this legislation.
As the corrective contact lens industry has grown, so has the
practice of using noncorrective contact lenses for cosmetic purposes.
Currently, there is very little regulation of these lenses. However,
all contact lenses have significant effects on the eye and pose health
risks if improperly manufactured or used without the supervision of a
qualified eye care practitioner. Both corrective and noncorrective
contact lenses have been approved as medical devices by the FDA. It
just makes sense that the FDA should have the authority to regulate
these lenses.
Mr. Speaker, having said that, I would urge all of my colleagues to
support this important resolution.
Mr. Speaker, I reserve the balance of my time.
Mr. BROWN of Ohio. Mr. Speaker, I yield myself such time as I may
consume.
Mr. Speaker, colored and patterned contact lenses can be a fun way to
express one's sense of style. Noncorrective contact lenses that are
manufactured responsibly and worn under the supervision of a qualified
eye care professional are useful and a perfectly safe commodity.
For years, the FDA saw it that way too and properly classified
colored contact lenses as medical devices. In fact, just over a year
ago FDA issued an official notification noting that noncorrective
contacts ``present significant risks of blindness and other eye injury
if distributed without the involvement of a qualified eye
professional.''
But in April, for whatever reason, and we have seen an FDA that has
become more and more politicized in the last couple of years, but for
some reason the FDA flip-flopped deciding that colored contact lenses
were not medical devices and were instead cosmetics. This quiet, but
important, policy change opened the door to a new public health threat.
[[Page H11566]]
By reclassifying colored contacts as cosmetics, FDA eliminated the
requirement that these products be manufactured to exacting standards,
that they be FDA approved for safety before marketing, and that they be
labeled with directions for safe use. FDA has expressed concern about
the safety of noncorrective lenses administered without a doctor's
involvement. But FDA's decision to reclassify them in this increasingly
politicized FDA, this decision to reclassify them eliminated its
authority to require that very involvement.
Despite concerns raised by Members in the House, but more importantly
by Prevent Blindness Ohio and other eye health advocates, FDA went
ahead with this misguided plan. This bill corrects that mistake by
statutorily reclassifying noncorrective contacts as medical devices by
statute. This bill was carefully drafted to ensure that this would be
its only effect, and it clearly states this change will have no
limiting effect on FDA's discretion in classifying other products under
the Food, Drug and Cosmetic Act.
H.R. 2218 enjoys bipartisan support in the Committee on Energy and
Commerce. The chairman of the Subcommittee on Health, the gentleman
from Florida (Mr. Bilirakis), and I have cosponsored this legislation,
as have several other colleagues; and I am joined on the floor today by
two other leading health advocates, the gentleman from California (Mr.
Waxman) and the gentlewoman from California (Ms. Eshoo). I urge my
colleagues to join us in supporting this important legislation in
protecting the vision and health of American consumers.
Mr. Speaker, I reserve the balance of my time.
Mr. BILIRAKIS. Mr. Speaker, I yield such time as he may consume to
the gentleman from Arkansas (Mr. Boozman), who is himself an
optometrist and certainly has lived with this problem for many, many
years and knows the real world, and I thank the gentleman for bringing
this to our attention.
Mr. BOOZMAN. Mr. Speaker, I thank the gentleman from Florida
(Chairman Bilirakis) for yielding me this time.
I also thank the gentleman from California (Mr. Waxman) and his staff
for working so hard on this bill. They have really gone above and
beyond the call of duty in spending a great deal of time getting this
to the situation that we have now. I also thank the gentleman from
Florida (Mr. Bilirakis) for his help and the gentleman from Louisiana
(Mr. Tauzin).
Today we have the opportunity to close a loophole that has caused
harm to many people young and old throughout the country. The loophole
is a quirk in the law that allows decorative, plain old contact lenses
to be sold without a prescription. Although this may not sound like a
big deal, as a practicing optometrist for over 25 years, it is.
There are many cases of damage caused by contact lenses sold without
the supervision of an eye care professional. Take, for instance, the
case of a 14-year-old girl who purchased a pair of decorative contact
lenses from a local video store and received no instructions on how to
care for them. She ended up suffering a severe bacterial eye infection,
and ultimately had to have a corneal transplant, which is a very
significant surgery. Or the 32-year-old man who bought a pair of lenses
at the local flea market for a Halloween costume. Again, the customer
was provided with no directions at all on proper usage. He was later
diagnosed with a corneal abrasion. He had scratched his eye because
they did not fit his eye. He was later in a situation that resulted in
possible permanent loss of vision.
Unfortunately, there are many, many more people whose vision has been
compromised because of this type of contact lens being available to the
general public without the supervision of eye care professionals. It is
important to know that although adults are affected by the availability
of these lenses, our children are the most vulnerable. As all of us who
have children know, reason is often overruled by the desire to be
fashionable and trendy.
Selling lenses to change one's eye color in video stores, flea
markets, hair salons, and gas stations is inviting trouble and,
frankly, should not be allowed.
A simple eye infection is the least of problems with unsupervised
contact lens use. The worst is it can lead to permanent blindness.
Proper care of the lenses and instructions on the correct way to use
them are the keys to preventing these afflictions. Consumers are not
getting this information from the video store clerk or the gas station
attendant.
H.R. 2218 presents a simple fix to a dangerous problem. This bill is
not intended to address the complicated legal issues surrounding
intended use. The gentleman from California (Mr. Waxman) and I have
worked hard to ensure that the language in this bill remains neutral on
this question, and I think we have succeeded.
Additionally H.R. 2218 is being endorsed by the health care
community, including the American Optometric Association and the
American Academy of Ophthalmology, as well as the leading manufacturers
in the contact lens industry and consumer protection groups.
Mr. Speaker, I cannot stress strongly enough that unregulated,
unsupervised use of decorative contact lenses is extremely hazardous to
one's health. H.R. 2218 would simply close that loophole that allows
these lenses to be sold unregulated. I would strongly encourage my
colleagues to support H.R. 2218.
Mr. BROWN of Ohio. Mr. Speaker, I yield such time as he may consume
to the gentleman from California (Mr. Waxman).
Mr. WAXMAN. Mr. Speaker, I thank the gentleman for yielding me this
time.
I am very pleased to be able to join my colleagues in urging support
for a bill that deems all contact lenses to be medical devices under
the Federal Food, Drug and Cosmetic Act; and I thank the gentleman from
Arkansas (Mr. Boozman) for his leadership in sponsoring this
legislation. Anyone who has any doubts about how significantly contact
lenses affect the structure and function of the eye need only spend a
few minutes talking with the gentleman from Arkansas (Mr. Boozman),
who, by virtue of his professional training, understands these dangers
better than anyone else in the House of Representatives.
This bill is urgently needed. All contact lenses pose serious health
risks. Lenses the wrong size can deprive the surface of the eye of
oxygen. Lenses worn for too long can cause painful ulcerations of the
cornea. Lenses that are poorly manufactured or misused can become
contaminated and cause vision-threatening infections. Until recently,
FDA had the tools to control the risks of contact lenses. They
considered all lenses of all types to be Class III medical devices.
Using its medical device authority, the FDA required that companies
follow good manufacturing standards, obtain approval prior to
marketing, report adverse events promptly, and sell their lenses only
with a prescription from an eye care professional.
However, under FDA's current interpretation of the law, some contact
lenses are now considered cosmetic, nonmedical devices. These lenses,
which the agency refers to as decorative lenses, are colored or feature
unusual designs. These lenses pose exactly the same health risks as
other lenses, yet today these lenses only have to comply with
requirements for cosmetics, and there are very few requirements and
they are difficult to enforce.
Treating them in this way, I believe, is a recipe for disaster.
Lenses sold outside the protections of medical device laws have caused
numerous eye injuries. It is critically important that FDA have the
ability to stop these dangerous sales as quickly and efficiently as
possible. The solution is simple: treat all contact lenses as medical
devices. No contact lenses should be classified in the same category as
lipstick.
H.R. 2218 would ensure that all contact lenses are treated the same
as medical devices. This bill is enforced by professional associations
representing ophthalmologists and optometrists, by leading
manufacturers and by consumer groups. It is a basic consumer
protection, and it is common sense.
Finally, let me say this bill has been written with the understanding
and agreement of all parties that it should not be interpreted as
either a rejection or a ratification of the legal arguments
[[Page H11567]]
underlying FDA's decision to treat noncorrective lenses as cosmetics.
For that reason, the bill includes a rule of construction stating that
the bill should not be construed as having any effect on any product
regulated by the FDA other than the specific contact lenses at issue
here. I thank the gentleman from Ohio and the distinguished chairman of
the Subcommittee on Health, and I join with every Member who has spoken
on this bill in urging support for it.
Mr. BILIRAKIS. Mr. Speaker, I have no further requests for time, and
I yield back the balance of my time.
Mr. BROWN of Ohio. Mr. Speaker, I have no further requests for time,
and I yield back the balance of my time.
The SPEAKER pro tempore (Mr. Ose). The question is on the motion
offered by the gentleman from Florida (Mr. Bilirakis) that the House
suspend the rules and pass the bill, H.R. 2218, as amended.
The question was taken; and (two-thirds having voted in favor
thereof) the rules were suspended and the bill, as amended, was passed.
The title of the bill was amended so as to read: ``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.''.
A motion to reconsider was laid on the table.
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