What’s Behind the New LASIK Guidance?

Attorney Jeffrey Shapiro (Hyman, Phelps & McNamara) says it appears that FDA issued a 7/29 guidance on LASIK laser patient labeling in an attempt to “induce manufacturers to seek approval of a labeling change, and to direct them as to what changes they should request.” Writing in his firm’s FDA Law Blog, Shapiro says the broad scope of the guidance is “curious.”

He notes that approved devices already have patient-directed labeling that the agency has approved. “Why would it be necessary for FDA to issue a new set of patient labeling recommendations in a non-binding guidance?” he asks. “How could the manufacturers even follow the guidance without illegally departing from their previously approved labeling? What is going on here?”

Shapiro’s analysis is that FDA recognizes that PMA holders have a limitation in their ability to adopt the recommendations in the new guidance. “It would appear that the purpose of the guidance is really to induce manufacturers to seek approval of a labeling change, and to direct them as to what changes they should request,” he says. “As FDA points out, the agency can readily impose this labeling for new devices during an original PMA process, but they need existing PMA holders to ‘voluntarily’ file supplements to make these changes.”

Shapiro says it would seem that the targeted current PMA holders would be on “rock-solid legal ground” to ignore the guidance. “They may legally continue to use their existing PMA-approved labeling,” he adds. “No doubt, if FDA persists, some manufacturers may be unable to resist the pressure. That does not speak to the propriety of this maneuver.”

Shapiro concludes that the issue is that FDA seeks to substitute new patient labeling based on a generalized assessment of procedural outcomes obtained through a wide range of medical information, not device-specific evaluations. Perhaps more important, he continues, FDA is asking that the labeling convey risk information to patients that overlaps with routine surgical informed consent.

“FDA’s mandate, however, is to supervise the safety and effectiveness of specific devices used in LASIK procedures,” Shapiro writes. “FDA is not authorized to impinge on the informed consent process. It is a subtle distinction, but it is well-established and is usually honored by the agency. In this case, it appears that FDA has crossed over the line.”