Medical Device & Diagnostic Industry

Accountability Act, which since 1996 has guaranteed patient privacy, might be to blame. But that law applies to the provider community and exempts federal agencies such as FDA.

Outsiders’ inquiries must go through channels, which in my case meant through the press office. Days passed,

Schultz seeks to dis-

pel the idea that no

action has been taken

since the public meet-

ing on LASIK devices

and procedures.

and to cut a long story short, eventually two contradictory explanations were offered:

• Because most of the commenters “were not informed that written comments could be posted on a public Web site...CDRH opted to ensure the protection of personal privacy information and redacted personal, patient, and doctor information from the written comments received.” Moreover, other redactions were made because “device and manufacturer names are often associated with a particular LASIK center...[and] were removed uniformly to prevent association of either negative or positive comments with a particular LASIK provider.”

• Rather than CDRH “opting” to redact certain information, FDA established a “policy” of not posting individual consumer comments at all “due to the high number of individual consumer requests to remove their names and comments from the FDA Web site. In addition, 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 despite the fact that 252 such comments remained posted, albeit in redacted form.

Patients claiming injuries from their LASIK procedures took to the blog-osphere to allege that FDA was in a conspiracy with the American Society of Cataract and Refractive Surgery to suppress bad news about the wildly popular and profitable procedure.

Meanwhile, FDA on Sept. 12 opened a formal public docket to receive public comments on LASIK experiences, which it said in a Federal Register notice “may be posted to the FDA’s Web site for public viewing.” The notice did not say that personal or other identifying information would be redacted from such comments.

As to the agency’s claim that it now has a “policy” of not posting such comments to its Web site, Washington attorney Larry Pilot, of McKenna Long & Aldridge LLP, promptly challenged the agency in an e-mail in which he said the policy was new to him. He asked for a copy of the policy “along with related supporting documents. In addition,” he said, “please identify the statutory reference that supports such policy and explain how this policy is reconciled with specific language appearing in FDA’s [Freedom of Information Act] regulations appearing in 21 CFR Part 20.” That’s the regulation stating that public comments to FDA are just that: public.

Further tangling the LASIK web is the fact that CDRH does indeed have a partnership, as its LASIK-dissatisfied critics complain, with the American Society of Cataract and Refractive Surgery. The agency has said nothing publicly about the

FOR PREVIOUS COVERAGE OF LASIK ADVERSE EVENTS, GO TO

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policy, possibly fueling the suspicion and conspiracy theories being advanced in cyberspace. But according to the society’s Web site, the partnership also involves the National Eye Institute and the American Academy of Ophthalmology. The society created a joint LASIK Task Force to study LASIK vision correction and its effect on the quality of patients’ daily lives.