Copyright Dickinson FDA Webview at www.fdaweb.com. Republished by permission.
11/5/2013

FDA explains how a little-noticed change in its conditions of approval for LASIK lasers removed a patient-protection requirement two years before public complaints about eye injuries from the procedure erupted.

Two years before rising complaints erupted in public from LASIK patients with post-surgical vision problems, FDA’s Center for Devices and Radiological Health, on its own initiative, quietly removed a LASIK laser condition of approval that “[p]rospective patients, as soon as they express an interest in LASIK and prior to undergoing surgery, must receive from the treatment provider the Patient Information Booklet.” It took injured LASIK activists seven more years to notice the language change in CDRH laser PMA approval letters.

Last week, activist Paula Cofer questioned the approval letters’ language change in an email to FDA Webview editor Jim Dickinson, who in turn asked FDA for an explanation, and whether the change had been sought by the LASIK laser industry or by eye surgeons’ representatives. Both communities had been accused by activists for years of not passing on FDA-approved patient labeling to prospective patients prior to LASIK surgery. Although Cofer says their adequacy “is all over the place,” FDA-approved LASIK Patient Information Booklets often contain objective risk-benefit information, precautions and warnings.

In a response from FDA public information officer Synim Rivers, the agency acknowledged that it had used the missing language prior to 2006 as a condition of approval, and that it still requires final labeling (professional-use and patient labeling) from manufacturers during the review of marketing applications. “During this review,” Rivers’ response said, “we ensure that adequate safety/risk/procedural information is accurately conveyed in plain, understandable language. The manufacturer, in return, is required to provide this patient information booklet to the practitioner.

“In 2006,” the response continued, “we internally revisited the conditions of approval with respect to FDA’s regulations, and revised the conditions of approval for subsequent LASIK approvals. It is the responsibility of the practitioner, who is not regulated by the FDA, to provide the patient information booklet to their patients.”

As for whether the language change had been sought by industry or professional organizations, the response asserted that “the changes to our approval letter were not the result of external organizations or inquiries from external organizations. Instead, the changes were a direct result of internal discussions.”

Cofer told FDA Webview the agency’s explanation for dropping the Patient Information Booklet requirement “doesn’t hold up to the smell test,” especially since the change occurred shortly after the responsible CDRH review division was taken over by an ophthalmologist (Malvina Eydelman). “Malvina attends their conferences and rubs elbows with the leading refractive surgeons,” Cofer said.

“Why would FDA require patient labeling for LASIK devices, but not communicate the necessity of providing it to prospective patients? And how is this any different from a pharmacist negligently not providing patients with drug labeling? Why are patients’ rights more protected when they pop a pill than when they undergo an irreversible elective surgery on their eyes?

“Why not just clarify in the approval letter that the manufacturer is required to provide practitioners with patient labeling, and practitioners are required, in turn, to provide the patient labeling to ‘prospective patients as soon as they express an interest in LASIK and prior to undergoing surgery’, rather than simply eliminating the mandate from the approval letters altogether? This deliberate omission of the patient labeling mandate from the approval letters indicates that the agency is more concerned about protecting refractive surgeons than in ensuring that patients are fully informed of the known risks of LASIK.”