[Congressional Record (Bound Edition), Volume 151 (2005), Part 17]
[House]
[Pages 23878-23880]
[From the U.S. Government Publishing Office, www.gpo.gov]




AMENDING FEDERAL FOOD, DRUG, AND COSMETIC ACT TO PROVIDE FOR REGULATION 
                OF ALL CONTACT LENSES AS MEDICAL DEVICES

  Mr. DEAL of Georgia. Mr. Speaker, I move to suspend the rules and 
pass the Senate 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.
  The Clerk read as follows:
       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. 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 Device

       ``(n)(1) All contact lenses shall be deemed to be devices 
     under section 201(h).
       ``(2) Paragraph (1) shall not be construed as bearing on or 
     being relevant to the question of whether any product other 
     than a contact lens is a device as defined by section 201(h) 
     or a drug as defined by section 201(g).''.

  The SPEAKER pro tempore. Pursuant to the rule, the gentleman from 
Georgia (Mr. Deal) and the gentleman from California (Mr. Waxman) each 
will control 20 minutes.
  The Chair recognizes the gentleman from Georgia (Mr. Deal).


                             General Leave

  Mr. DEAL of Georgia. Mr. Speaker, I ask unanimous consent that all 
Members may have 5 legislative days within which to revise and extend 
their remarks and include extraneous material on S. 172.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from Georgia?
  There was no objection.
  Mr. DEAL of Georgia. Mr. Speaker, I yield myself such time as I may 
consume.
  Mr. Speaker, I am proud to rise in favor of S. 172, and I would like 
to thank the gentleman from Arkansas (Mr. Boozman) and the gentleman 
from California (Mr. Waxman) for their work on the House companion 
bill, which was H.R. 371.
  Historically, the contact lens industry in the United States has 
secured prior approval from or clearance by the Food and Drug 
Administration prior to the introduction of contact lenses into the 
United States market. These same contact lens manufacturers also have 
been subjected to and complied with numerous requirements codified in 
the Federal Food, Drug, and Cosmetic Act.
  A few companies challenged the FDA's ability to regulate non-
corrective decorative contact lenses as medical devices to create a 
loophole in the current law. As a result, these entities distribute 
their products without the attendant controls that historically have 
safeguarded contact lens consumers.

[[Page 23879]]

  The uncontrolled distribution of decorative contact lenses has caused 
a variety of eye injuries and conditions. At first, what might seem to 
be a minor irritation, if left untreated, can develop permanent eye 
damage and loss of vision. S. 172 would close this loophole by 
restoring the FDA's ability to regulate all contact lenses as medical 
devices.
  Mr. Speaker, I urge Members to support this legislation.
  Mr. Speaker, I reserve the balance of my time.
  Mr. WAXMAN. Mr. Speaker, I yield myself such time as I may consume.
  Mr. Speaker, I rise to join my colleagues, particularly the gentleman 
from Arkansas (Mr. Boozman), in supporting this important bill to apply 
the highest safety standards and consumer protections to all contact 
lenses.
  This legislation became necessary on April 4, 2003. On this date, the 
Food and Drug Administration decided to classify certain colored 
contact lenses as cosmetics, not medical devices. This classification 
made no sense. Cosmetics are not required to be made according to 
strict manufacturing standards; cosmetics are not reviewed for safety 
prior to marketing; and cosmetics are not prescribed by a doctor.
  The loose regulatory approach to cosmetics may work for lipstick; but 
it is dangerous for contact lenses, which are placed directly on the 
eyes. If contact lenses are not made properly, they can cause severe 
infections. If lenses do not fit properly, they can cause disfiguring 
ulcers, and if lenses are worn by teenagers or others without the 
ongoing supervision of an eye care professional, severe injuries can 
result.
  Since April 4, 2003, scores of teenagers and young adults have been 
injured by cosmetic contact lenses. Some have permanently lost vision. 
Others have required corneal transplants. In one survey in Louisiana, 
85 percent of optometrists and 45 percent of ophthalmologists reported 
diagnosing eye injuries from contact lenses sold without a 
prescription.
  Since April 4, 2003, I have worked with the gentleman from Arkansas 
(Mr. Boozman), contact lens manufacturers, the American Academy of 
Ophthalmology, the American Optometric Association, and consumer 
advocates to ensure that all contact lenses are regulated according to 
the strict standards and consumer protections applied to medical 
devices.
  In the 108th Congress, our legislation passed the House, but not the 
Senate. In late July of this year, the legislative approach that we 
designed passed the Senate. It is this legislation that is again before 
the House.
  By passing this bill, we can ensure the FDA protects consumers from 
unsafe contact lenses, we can prevent serious eye injuries, even 
blindness, and we can send a timely message to teenagers and their 
parents about the dangers of unsupervised use of contact lenses at 
Halloween.
  I would like to express my appreciation to Senators DeWine and 
Kennedy for guiding this legislation through the Senate, I would like 
to thank those at FDA who supported our legislative solution, and I 
recognize the efforts of experts such as Thomas Steinemann in 
Cleveland, who worked hard to raise awareness about the availability 
and dangers of unsafe lenses.
  I especially want to thank and congratulate our colleague, the 
gentleman from Arkansas (Mr. Boozman), for his persistence and hard 
work in the House of Representatives. I urge my colleagues to support 
this bipartisan consensus legislation today.
  Mr. Speaker, I reserve the balance of my time.
  Mr. DEAL of Georgia. Mr. Speaker, I am pleased to yield such time as 
he may consume to the gentleman from Arkansas (Mr. Boozman), who is the 
original cosponsor of the House companion bill to this legislation.

                              {time}  1745

  Mr. BOOZMAN. Mr. Speaker, last Congress, myself, Mr. Waxman in the 
House, Senator DeWine, Senator Kennedy in the Senate, became aware of a 
very serious problem. The FDA had claimed jurisdiction over all contact 
lenses, and then in April of 2003 announced that it did not feel like 
it had jurisdiction over contact lenses that did not have any power in 
them anymore. In other words, there were lenses that were sold for the 
purpose of changing eye color, sold at Halloween to enhance; if you 
were going to a whatever and wanted to look kind of wild, you could buy 
these lenses. Up until then, everyone agreed that a contact was a 
contact, but when they got to looking at their statute, they were very 
concerned that they did not have any jurisdiction.
  As a result, these lenses began being sold at flea markets, began 
being sold at places where you get your nails done, and when they were 
sold, no one told them how to put them in and take them out, there was 
no effort at all to teach anything about hygiene, the disinfecting 
solutions that you needed to prevent your eyes from becoming infected.
  Dr. Steineman at Case Western Reserve about this time started seeing 
a tremendous incidence in eye infections related to these lenses. Let 
me just tell my colleagues about a couple of them. Here is an example 
of a young gal that was 16 years old. Her boyfriend supplied her with 
these colored contact lenses, did not have any power in them, so they 
were not regulated. The patient admitted to sharing the colored contact 
lenses with her younger brother, again doing this because she had no 
idea of how you take care of this type of situation.
  You say, well, it is just a 16-year-old. Here is an example of a 26-
year-old that also bought contact lenses at a flea market that made him 
have cat eyes. This individual developed a very significant, very 
severe infection, which probably resulted in loss of vision.
  Today what we are trying to do by passing this bill is to close the 
loophole which everybody agrees needs to be done. So the real heroes of 
this have been the FDA. We have worked very, very hard with them and 
have gotten language that they have agreed to; Dr. Steineman, in doing 
the early work in identifying this; and ophthalmology, optometry that 
have really pressed the issue in the House; the manufacturers of the 
particular lenses; Senator DeWine and Senator Kennedy in the Senate; 
and then also Mike Enzi, the chairman of the committee over there that 
really took this upon himself to get this thing passed. Mr. Waxman has 
done a tremendous job of working with us and just really going through 
in an effort to get the particular language that would get this done 
without affecting the jurisdiction of the FDA. So I really appreciate 
the gentleman from California; also, Chairman Barton and Chairman Deal 
in allowing this to go forward to get this to the floor. These were the 
guys that really allowed us to get this done. We had a goal of getting 
this done before Halloween, and I think we are almost there.
  The other thing I would like to do, which needs to be done more than 
we do it, is thank our staffs. They have put in literally countless 
hours trying to get this thing worked out.
  Again, I would urge all of my colleagues to support this bill. I 
think it is something that needs to be done, and it is one of those 
things that as a result of us getting this done today truly will 
protect our youth, protect people in keeping them from experiencing a 
devastating eye injury.
  I also want to thank the majority leader, Mr. Blunt, for getting this 
scheduled, again before Halloween.
  Mr. WAXMAN. Mr. Speaker, I yield myself such time as I may consume.
  I want to thank my colleague from Arkansas for his very kind words 
and join him in saluting all of the Members of the House and the Senate 
and our staffs who have worked on this legislation. I do not want to 
dwell on why the FDA decided to regulate some lenses as cosmetics 
rather than medical devices. Congressman Deal referred to it as a 
loophole. I consider it a lapse in enforcement. Regardless, this bill 
is neutral on what went wrong. It just fixes the problem, and that is 
what we need to do. I would urge all of our colleagues to join us in 
supporting the legislation.
  Mr. Speaker, I yield back the balance of my time.
  Mr. DEAL of Georgia. Mr. Speaker, I have no further requests for 
time, I urge the adoption of this Senate bill,

[[Page 23880]]

and I yield back the balance of my time.
  The SPEAKER pro tempore (Mr. Gingrey). The question is on the motion 
offered by the gentleman from Georgia (Mr. Deal) that the House suspend 
the rules and pass the Senate bill, S. 172.
  The question was taken; and (two-thirds having voted in favor 
thereof) the rules were suspended and the Senate bill was passed.
  A motion to reconsider was laid on the table.

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