The U.S. Food and Drug Administration (FDA) is considering comments to their risk-focused draft guidance, “Laser-Assisted In Situ Keratomileusis (LASIK) Lasers-Patient Labeling Recommendations.” Although LASIK is one of the most commonly performed elective procedures in the world, responses to the draft guidance have been mixed.
The draft guidance was issued in July 2022 “based on concerns that some patients are not receiving and/or understanding information regarding the benefits and risks of LASIK devices.” The FDA’s director of the Center for Devices and Radiological Health stated, “[i]t is important to provide patients with comprehensive labeling that clearly describes the risks involved with LASIK surgery, including potential adverse effects such as dry eye, pain and discomfort, and visual symptoms.”
The draft guidance provides recommendations on content and formatting for patient labeling information for LASIK devices. This content includes a patient decision checklist with a list of contraindications—pre-existing conditions indicating when a patient should not receive LASIK—and warnings for pre-existing conditions that can increase the risk of serious harm due to LASIK. The FDA states that these labeling recommendations are meant to enhance doctor-patient discussions, not replace them.
The guidance received more than 650 comments ranging from being viewed as “timely and beneficial” to requests that it be withdrawn. Some of the most common criticisms are that the guidance’s recommended labeling would mislead patients because it does not describe the potential benefits, that the document fails to cite relevant literature references, and that the guidance interferes with the doctor-patient relationship.
Many commenters also focus on the fact that refractive laser systems for LASIK are already subjected to a rigorous safety approval process. Between 2009 and 2021, the FDA approved more than 115 refractive laser systems for LASIK using the premarket approval (PMA) submission process. PMA approval is the most stringent type of device marketing application. In order to receive approval, the FDA carefully reviews several critical pieces of medical device information, including product labeling. Critics ask why the FDA requires additional labeling and patient counseling when it has already made a determination that the devices are safe for their intended use. However, it is not uncommon for the FDA to institute new labeling policies for devices that have already undergone FDA review, including through the PMA process. Recent examples include the Essure contraception device, and breast implants. LASIK lasers could be next, though in light of the controversy, it is possible that the FDA may seek further stakeholder input prior to guidance finalization. These opportunities could come in the form of a public meeting, reproposed draft guidance, or public notice requesting comments on specific scientific or regulatory questions.
In the meantime, it remains to be seen whether the draft guidance’s recommendations will affect patients’ interest in and willingness to undergo the surgery.
For more information, please contact Georgia Ravitz, David Hoffmeister, Eva Yin, Shari Esfahani, or any member of the firm’s FDA regulatory, healthcare, and consumer products practices.
Alex DeLaney contributed to the preparation of this Wilson Sonsini Alert.
