Draft LASIK Guidance: Why Did FDA Issue New Labeling Recommendations for Products that Already Have PMA Approved Labeling?

December 13, 2022By Jeffrey K. Shapiro

Last summer, FDA published a draft guidance, Laser-Assisted In Situ Keratomileusis (LASIK) Lasers – Patient Labeling Recommendations (July 29, 2022) setting forth a proposal for new recommended patient‑directed labeling.  It is focused on excimer lasers with premarket application (PMA) approval for LASIK  in product code LZS.  This proposal is not, however, simply advice for preparation of an application for a new device.  The draft guidance purports to apply to current PMA holders.  This broad scope is curious.  The approved devices already have patient‑directed labeling that FDA has approved.  Why would it be necessary for FDA to issue a new set of patient labeling recommendations in a non‑binding guidance?  How could the manufacturers even follow this guidance without illegally departing from their previously approved labeling?  What is going on here?

Draft Guidance

In the draft LASIK guidance, FDA has a 15‑page outline of recommended patient labeling, broken into 10 subsections that would address things like the risks, benefits, and possible alternatives to LASIK.  In an appendix, FDA provides a model “decision check list” for patients.  It looks similar to the type of procedural informed consent a surgeon ordinarily would present to a patient.  The introductory paragraph states:

The review and understanding of this document is a critical step in making the decision whether you should choose LASIK surgery.  This form lists important risks, including those known or reported to be associated with the use of the LASIK laser devices based on information from clinical trials, scientific literature, and reports from patients who have undergone LASIK.  After reviewing the information . . . please read and discuss the items in this checklist with your doctor. You should place your initials in the location provided next to each item to indicate that you have read and understood the item. Your full signature at the end of this document means that you have read and understood the materials and that your physician has answered all questions to your satisfaction.  [Draft LASIK Guidance at 22.]

Public Comments

It was this apparent foray into the realm of informed consent that appears to have provoked considerable backlash in the public comments on the draft guidance.  The Refractive Surgery Council (RSC) and Society for Excellence in Eyecare (SEE), the Medical Device Manufacturers Association (MDMA), and even the Commonwealth of Kentucky’s attorney general (AG) all requested the draft guidance be withdrawn.  All of them stated some version of an argument that this guidance requires labeling that will overlap and potentially clash with the informed consent process.  MDMA, for example, states:

The patient labeling recommendations in the Draft Guidance inappropriately require manufacturers, rather than surgeons, to provide information to patients regarding the risks of LASIK as a procedure, as distinct from the risks of the approved device (i.e. excimer laser systems) used to perform the procedure. The Draft Guidance incorporates a Patient Decision Checklist Example (the “Checklist”) at Appendix A, which would become part of the device’s labeling.  There appears to be significant overlap in content between the Checklist and informed consent forms and processes routinely provided by healthcare providers to their patients. MDMA is concerned this Checklist will not assist patients in their decision regarding whether to undergo surgery, but rather do the opposite by presenting potentially conflicting informed consent information. In addition, the Checklist is not device-specific and may not reflect the data contained in the manufacturer’s premarket approval application (PMA). This proposal is a[n] . . . intrusion [into] the doctor-patient relationship.

The Kentucky AG uniquely adds that FDA’s proposal improperly interferes with the Commonwealth’s exercise of supervisory authority over its physicians, including statutes addressed to obtaining informed consent.

There was also controversy in the comments over how to characterize LASIK’s risks, underscoring how far FDA seems to have strayed from its statutory mandate.  The argument was not about evaluating the performance of a particular device, which is FDA’s bread and butter.  Rather, it was about the assimilation of the full range of available medical data and information to assess how procedural risk generally should be conveyed to patients, regardless of the specific LASIK device being used.

More than one commenter on the draft guidance was troubled that FDA’s proposed labeling fails to incorporate most recent data bearing on LASIK’s risks.  Additionally, several of the commenters pointed out apparent errors in FDA’s characterization of risk.  We are not equipped to say who is right about the data, but this dialogue seems to be playing out on the medical professionals’ home turf.

Regulatory Analysis

We return now to the puzzle of how these new draft recommendations relate to the previously approved labeling for these devices.  FDA describes the legal effect of the draft guidance as follows:  “The contents of this document do not have the force and effect of law and are not meant to bind the public in any way. . . .  This document is intended only to provide clarity to the public regarding existing requirements under the law.”  In this context, this statement is absurd.  FDA has already approved the patient labeling in connection with each individual manufacturer’s PMA approval.  None of the manufacturers require any clarification, since FDA has already specifically reviewed and approved the labeling.

At the end of this discussion, we learn what the game is.  The draft guidance states (p. 4):  “FDA intends to work with manufacturers of new LASIK devices through the premarket approval application (PMA) process, and manufacturers of currently marketed LASIK devices through the PMA supplement process, to integrate these important labeling recommendations.”

FDA’s statement tacitly concedes that current PMA holders have a limitation on their ability to adopt the recommendations in this guidance.  As a legal matter, they would need to first obtain supplemental approval from FDA granting them permission to do so.  It appears that the purpose of the guidance is really to induce manufacturer’s to seek approval of a labeling change, and to direct them as to what changes they should request.  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.

The draft guidance is directed at devices in the LZS product code, most of which originally gained approval in the mid‑1990s to early 2000s.  While there are PMA supplements steadily filed in this product code until the present, it appears from FDA’s database that the last original PMA approval was in 2006.  Therefore, it is likely that this guidance is really directed at existing PMA holders.

It would seem that these targeted PMA holders would be on rock solid legal ground to ignore the guidance.  They may legally continue to use their existing PMA‑approved labeling.  No doubt, if FDA persists, some manufacturers may be unable to resist the pressure.  That does not speak to the propriety of this maneuver.

A final word about the limits of FDA’s authority.  FDA is not categorically barred from requiring manufacturers to provide patient information.  These lasers were previously approved with patient information booklets.

The problem here is that FDA seeks to substitute new patient labeling based on a generalized assessment of procedural outcomes obtained via a wide range of medical information, not device‑specific evaluations.  And, perhaps more important, FDA is requesting that the labeling convey risk information to patients that clearly overlaps with routine surgical informed consent.  FDA’s mandate, however, is to supervise the safety and effectiveness of specific devices used in LASIK procedures.  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.

Categories: Medical Devices