James p. Mc culley, md, Chair

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Meeting of:




July 23, 1999

July 23, 1999

Gaithersburg Hilton

620 Perry Parkway

Gaithersburg, Maryland

Reported By:

CASET Associates

10201 Lee Highway, Suite 160

Fairfax, Virginia 22030

(703) 352-0091



Call to Order, Introductory Remarks - Dr. McCulley 1

Open Public Hearing 8

Open Committee Discussion - Branch Updates 12

PMA P990014 20

PMA P930034\S13 90

Open Public Hearing 154



Voting Members:














LYNN MORRIS, Consumer Representative

MARCIA S.YAROSS, PhD, Industry Representative

SARA M. THORNTON, Panel Executive Secretary












P R O C E E D I N G S (8:15 a.m.)

AGENDA ITEM: Call to Order, Introductory Remarks.

DR. MC CULLEY: I want to call to order the Ophthalmic Device Panel meeting of July 23, 1999. I will turn the floor to Sarah Thornton.

MS. THORNTON: Good morning, and welcome to everyone. Before we go on with today's agenda, I will make the same few short announcements that I made yesterday.

I would like to remind everyone that you are requested to sign in on the attendance sheets in the registration area, just outside the meeting room.

You can pick up an agenda there, and information about today's meeting and how to obtain summary minutes or panel transcripts after the minutes.

Please make a note that there is a panel meeting tentatively scheduled for September 23, 1999. Stay tuned to our web site.

I think probably in the next week or two there will be further information on that meeting.

Messages for the panel members and FDA participants, information or special needs should be directed through Ms. Anne Marie Williams or Ms. Theresa Lewis, who are available at the registration table.

This is Anne Marie Williams right here. She will be able to help you, I am sure.

For those of you with cell phones and pagers, we ask that you turn them off or put them on the vibration mode, so as not to disturb the panel or anyone making presentations.

I wanted to note, for the folks who are going to be presenting, that there are name tents on the table. This is for FDA staff. Just pick out whichever name you like, and you can put it up while you are presenting, but they are over there on the table for you.

Please, speak into the microphone and give your name clearly. This applies mostly to panel members, but also to anyone who is making presentations.

It is very important for us to have accurate reporting, as well as the correct name with the correct comment.

I would like now to extend a special welcome to our panel for the second day, and to express FDA's appreciation for the time they have taken from their schedules to prepare for this meeting. We truly appreciate it.

Please introduce yourselves for the record, panel, beginning with Dr. Yarros.

DR. YARROS: Marcia Yarros, director of regulatory affairs for Allergan in Irvine, California, and industry representative to the panel.

MS. MORRIS: I am Lynn Morris with the state department of consumer affairs in California.

DR. FERRIS: Frederick Ferris, director of the division of biometry and epidemiology, National Eye Institute.

DR. VAN METER: Woodford Van Meter, private practice in cornea and external disease in Lexington, Kentucky.

DR. MACSAI: Miriam Macsai, professor of ophthalmology, West Virginia University School of Medicine.

DR. JURKUS: Janice Jurkus, professor of optometry, Illinois College of Optometry.

DR. HIGGINBOTHAM: Eve Higginbotham, professor and chair, department of ophthalmology, University of Maryland School of Medicine.

DR. PULIDO: Jose Pulido, professor and head, department of ophthalmology, University of Illinois.

DR. MC CULLEY: Jim McCulley, department of ophthalmology, University of Texas Southwestern Medical School.

DR. SUGAR: Joel Sugar, professor and vice chair, department of ophthalmology, University of Illinois at Chicago.

DR. BULLIMORE: Mark Bullimore, associate professor, The Ohio State University College of Optometry.

DR. GRIMMETT: Michael Grimmett, assistant professor, department of ophthalmology, University of Miami School of Medicine.

DR. MATOBA: Alice Matoba, associate professor of ophthalmology, Baylor College of Medicine.

DR. MANNIS: Mark Mannis, professor of ophthalmology, University of California, Davis.

DR. WANG: Ming Wang, director of refractory surgery, Vanderbilt University.

DR. ROSENTHAL: Ralph Rosenthal, director of the division of ophthalmic devices.

MS. THORNTON: Thank you. I would like to read the conflict of interest statement for the ophthalmic devices panel meeting for July 23, 1999.

The following announcement addresses conflict of interest issues associated with this meeting and is made part of the record to preclude even the appearance of an impropriety.

To determine if any conflict existed, the agency reviewed the submitted agenda and all financial interests reported by the committee participants.

The conflict of interest statutes prohibit special government employees from participating in matters that could affect their or their employers financial interests.

However, the agency has determined that participation of certain members and consultants, the need for whose services outweigh the potential conflict of interest involved, is in the best interests of the government.

Waivers are on file for Drs. Woodford Van Meter and James McCulley, and waivers have also been granted for Drs. Eve Higginbotham, Jose Pulido and Ming Wang, for their interests in firms that could potentially be affected by the panel's deliberations.

The waivers allow these individuals to participate fully in the panel's deliberations. Copies of these waivers may be obtained from the agency's Freedom of Information Office, Room 12-A-15 of the Parklawn Building.

We would like to note for the record that the agency took into consideration certain matters regarding Drs. Mark Bullimore, Frederick Ferris, Eve Higginbotham, Janice Jurkus, Marianne Macsai, Mark Mannis, James McCulley and Ming Wang.

These individuals reported past and/or current interests in firms at issue, but in matters not related to the specific issues of today's agenda.

Therefore, the agency has determined that they may fully participate today. The agency also considered Drs. Michael Grimmett's and Mark Mannis' reported involvements related to vision correction.

In the absence of any financial interests, the agency has determined that they may participate fully in today's deliberations.

In the event that the discussions involve any other products or firms not already on the agenda, for which an FDA participant has a financial interest, the participant should excuse him or herself from such involvement, and the exclusion will be noted for the record.

With respect to all other participants, we ask, in the interests of fairness, that all persons making statements or presentations disclose any current or previous financial involvement with any firm they may wish to comment upon.

I would like to now read the appointment to temporary voting status.

Pursuant to the authority granted under the Medical Devices Advisory Committee charter, dated October 27, 1990, as amended April 20, 1995 and October 10, 1997, I appoint the following individuals as voting members of the ophthalmic devices panel for the duration of this meeting on July 23, 1999:

Drs. Frederick Ferris, Mark Mannis, Woodford Van Meter, Alice Matoba and Ming Wang.

I also appoint Dr. Michael Grimmett as a voting member of the panel for the discussion of the intraocular lens for the correction of aphakia.

For the record, these persons are special government employees and are consultants to this panel or consultants or voting members of another panel under the Medical Devices Advisory Committee.

They have undergone the customary conflict of interest review and have reviewed the material to be considered at this meeting.

This is signed, Dr. David W. Feigel, Jr., director, Center for Devices and Radiological Health, July 21, 1999. Thank you, Dr. McCulley.

DR. MC CULLEY: Thank you. Just to add a new, so everyone knows up front, a new wrinkle to how we are doing business, we follow an agenda in the program that gives us an order of the things to do, and in some situations, the time frame within which it must be done, which we read and follow, or I read and we follow.

There has been one addition. That is, one of the primary reviewers will serve as scribe during the primary reviews, to list all the concerns that come up, so that we have those very well recorded, so I am not trying to do two or three things at once.

I am going to ask that Dr. Van Meter be the scribe this morning and Dr. Sugar the scribe this afternoon. Also, I won't go through everything I did yesterday, but everyone please remain aware of not only real conflict of interest, but the perception of conflict of interest, which can be drawn potentially in the minds of some people, if individuals are seen pow-wowing during the course of the meeting.

We must keep our comments on PMAs to ourselves and not discuss them with anyone in the audience or with ourselves.

With that, I would like to open the public hearing session of this meeting. Thirty minutes is allocated for public hearing, where members of the public may come forward and speak.

Each individual is limited to no more than 10 minutes. We have one person who has requested time prior to the meeting, Dr. William Bond.

AGENDA ITEM: Open Public Hearing.

DR. BOND: Thank you, Mr. Chairman. I am William Bond. I am an ophthalmologist in central Illinois. I am speaking for, this afternoon, the Summit Apex-Plus Laser, for the approval of LASIK. I have some prepared remarks.

As a Summit CRS investigator core study, I would like to respectfully submit to the panel the following points in support of labeling the Summit Apex-Plus Laser for LASIK.

LASIK is currently the true standard of care for refractive surgery in the United States and elsewhere. Extensive studies, including the CRS study, have proven LASIK on a Summit laser to be safe and effective.

DR. MC CULLEY: Excuse me. I hate to interrupt you, but I need for you please to state whether you have any conflicts of interest, who paid your way here, and things of that sort.

DR. BOND: I paid my own way here, missed a day and a half of work, and I own a Summit laser. I am out on this quite a bit.

DR. MC CULLEY: No accusations, just that we need it for the record, and it was pointed out to me that we hadn't gotten it.

DR. BOND: I am sorry. I own a Summit laser. Other than that, I am on my own.

Accuracy in labeling serves the entire public, not just the MDs and the laser manufacturers but, most of all, the patients.

LASIK is by far the most commonly performed refractive procedure on all eximer lasers, including the Summit Apex Plus.

This is because the surgeons actually treating the patients have found LASIK to be safe, effective, reliable and reproducible.

The laser should be approved and labeled for its most common actual use, and the use shown to be preferred by both doctors and patients.

Labeling the Summit Apex Plus laser for LASIK allows the LASIK procedure to be done in a manner best serving the public.

American patients should have access to the best LASIK software. Currently, better software for such things as central island prevention and multiple zones -- to give two examples of many -- is unavailable to the majority of the American public, although freely available outside the USA.

On-label LASIK would eliminate such unscientific, but politically mandated maneuvers such as double carding.

In my own experience with both the Summit Apex and the Summit Apex Plus laser, CRS software gives better results than the approved PRK software.

Regulations originally meant to protect patients wind up obstructing care, as knowledge and circumstances change.

For instance, I cannot access very low amounts of myopia in my Summit Apex Plus laser, which would be of great benefit to certain patients, particularly in enhancement situations.

These useful myopic instruments are not unavailable due to lack of engineering skill or scientific knowledge, but by decree, and not very recent decree.

The public is best served by frank talk among MDs. One of the things about my profession of which I have been the proudest has been the absolute free exchange of medical knowledge among doctors, exemplified by the remark, there are no secrets in medicine.

Ideas, results, concepts, techniques are shared freely for the benefits of everyone's patients. It is a wonderful tradition.

There is also a place for free and frank exchange between MDs and laser manufacturers, perhaps leading to advances in design.

Due to regulation, perhaps over-interpretation of regulation, we now often find ourselves in a Kafka-esque world of circumlocution, code words, particularly with manufacturers. On label LASIK would eliminate this unhealthy situation.

Not everyone here is a surgeon, but we are all patients. The interests of patients very rightly take precedence over all other considerations, but I would still like to mention a few issues that concern MDs directly.

On label LASIK is a direct benefit to MDs, because it resolves certain issues with professional liability insurance, which in turn affects cost of, and access to medical care.

Insurance companies prefer premiums to claims, and especially seem to dislike the claims on which they have to pay out.

LASIK is the established standard of care refractive procedure. An insurance carrier or plaintiff's attorney should not be able to deem LASIK experimental.

It is a lamentable state of affairs when a surgeon has to describe to the patient the most commonly done, safe and effective refractive procedure as off label, not approved by the FDA, investigational, experimental.

It is no longer the last two of these two, and should no longer be the first two. I thank you for your kind attention.

DR. MC CULLEY: Thank you. Does the panel have any questions for Dr. Bond? Seeing none, we thank you for your comments.

Time allows, if there are others in the audience who wish to come forward and make comment. Seeing none, we will close the open public hearing. The open committee discussions will begin with branch updates. Dr. Rosenthal?

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