In the wake of continuing patient complaints about injuries from vision-corrective LASIK (laser-assisted in situ keratomileusis) procedures, especially in ambulatory surgical facilities, CDRH director Daniel Schultz told FDA Webview 9/15 his Center is “putting together a total strategy for LASIK, and we are trying to get some of this stuff that we are doing out there.”

 

Speaking after an appearance at the Regulatory Affairs Professionals Society annual meeting in Boston, Schultz acknowledged that “there is this sort of this vacuum of information that looks like we had the public meeting and nothing has happened and that is not right.”

 

According to an FDA Webview on-line check the same day, CDRH’s Web site for LASIK has not been updated since March, a month before a 4/25 meeting of the Center’s Opthalmic Devices Panel heard patient testimony about injuries. Since then, the Center has “opted” to redact patient, physician, surgical facility, manufacturer and other information from the public comments it has received and posted to another part of its Web site.

 

In a 9/15 email to FDA Webview and other interested parties on the redaction issue, FDA Dockets Management Branch systems administrator Karen Kennard did not acknowledge CDRH’s decision to “opt” for redacting but instead cited an agency “policy” of not posting individual consumer comments, which she said “was established due to the high number of individual consumer requests to remove their names and comments from the FDA Web site. In addition,” Kennard continued, “if there is any personal information contained in the comment, it is not posted. Therefore, any comment which contains ‘individual consumer’ in the ‘Submitter Category’ or personal information in the comment, does not get posted to the FDA Web site. This does not mean that [they] are not reviewed by the scientific reviewers. Every comment is reviewed,” Kennard emphasized, “whether it is posted to the web or not.”

 

Meanwhile, as if to further muddy the picture, FDA on 9/12 opened a formal public docket to receive public comments on LASIK experiences which “may be posted to the FDA’s Web site for public viewing,” but did not say in its announcement that personal or other identifying information will be redacted from such comments.

 

One of the recipients of Kennard’s email, Washington attorney Larry R. Pilot (McKenna Long & Aldridge) promptly challenged her on the “policy” she claimed had been adopted.

 

“This ‘policy’ is new to me,” he said in a reply email. “Would you provide me with a copy of same along with related supporting documents? In addition, please identify the statutory reference that supports such policy and explain how this policy is reconciled with specific language appearing in FDA's FOIA regulations appearing in 21 CFR Part 20.”

 

Back in Boston and presumably not apprised of these new developments, Schultz volunteered to us that “We need to figure out how to get the information out there. There are a lot of angry people out there, no question, and I think we need to be careful when we put information out, you know, recognizing that are a lot of happy people out there.”

 

Asked by FDA Webview whether inspections would be part of the plan or whether there was a resource issue involved, Schultz answered: “No, I don’t think it is so much a resource issue. I think it should be part of an overall coordinated plan. Okay?” Already delayed, he quickly departed the dais.

Through FDA’s Press Office, Freedom of Information Division director Frederick J. Sadler told FDA Webview 8/27 that patient privacy concerns caused CDRH to “opt“ to redact information from public comments. Sadler did not address 21 CFR 20.103 regulatory requirements on disclosure, but did note that the comments were not submitted to “a formal docket,” nor did he cite statutory or regulatory authority for the redactions, which also included manufacturer and device names.

 

Sadler’s response in full follows:

 

“The comments were submitted to FDA’s Center for Devices and Radiological Health (CDRH) by members of the general public for the Ophthalmic Devices Advisory Committee meeting and not through a formal docket. Most of these comments contained personal (home) addresses, e-mail addresses, home telephone numbers, as well as the names of patients and their attending physicians. The vast majority of the written comments were from patients themselves, although in some cases the comments related to other persons who were known to, or related to, the writer.

 

“It is apparent that the majority of these persons were not informed that written comments could be posted on a public Web site. Many submitted extensive personal information about themselves, their medical conditions and treatment. Because CDRH received public comments up until and following the panel meeting, it was impossible to seek and obtain each correspondent’s permission to post the comments. Therefore, CDRH opted to ensure the protection of personal privacy information and redacted personal, patient and doctor information from the written comments received. While a docket was not available to receive comments prior to the meeting, CDRH is in the process of opening a docket to receive additional comments.”

 

As for other redactions, such as device names and their manufacturers, a follow-up question produced this response from the Press Office:

 

“The device and manufacturer names are often associated with a particular LASIK center. Therefore, they were removed uniformly to prevent association of either negative or positive comments with a particular LASIK provider.

 

“We will notify you when the public docket is open. At that time, any of the individuals who submitted comments previously will have the opportunity to post their un-redacted information to the public docket at that time with the full understanding that it will be widely available to the public.”

 

Washington device attorney Larry Pilot told FDA Webview that in his view, CDRH “has no right to ‘assume’ the intent of the writer or to act as his/her representative without permission. This is a public agency for which correspondence to the FDA is public unless otherwise stipulated. Many people appeared personally and explained their story with medical facts and physician identification. The CDRH knew who these people were in advance. So, did they advise any of them in advance that they should not identify themselves, wear masks, hide behind a screen, etc.? Give us a break!”

 

Meanwhile, FDA’s conduct of the 4/25 panel meetings that drew the comments continues to be controversial among the network of injured LASIK patients. Philadelphia-area elevator constructor Joseph Schnell, who was initially rebuffed due to a scheduling error when he showed up to present, told online network member 8/27 he considered the “the whole hearing a sham. ... I cannot think otherwise; I have spoken and written from my heart from the beginning of my LASIK experience and am becoming more convinced with the passage of time of the lack of oversight and premature approval of this procedure as well as many other refractive eye surgeries. The health of the patient is ignored and the fundamentals remain the same, that LASIK and other refractive eye surgeries are medically unsound.”

 

National Institute of Environmental Health Sciences molecular genetics core facility director Lauranell Burch, whose eyesight was allegedly impaired by LASIK, has petitioned FDA to ban the use of all refractive surgery lasers for LASIK surgery “due to substantial deception in the labeling and an unreasonable and substantial risk of injury.” Her petition also asks the agency to “acknowledge and enforce remedy for the misbranding of lasers used for LASIK (false and misleading labeling) due to failure to properly report adverse events and complications.”