Key industry stakeholders have asked the US Food and Drug Administration (FDA) to pull its recently published draft guidance on laser-assisted in situ keratomileusis (LASIK) patient labeling, arguing that the agency’s recommendations are based on faulty and outdated data and challenging its legal authority to issue the guidance.
The draft guidance, issued for comment in July, notes the FDA has become aware of more potential side effects of LASIK treatment and asks manufacturers to update their labeling so physicians can discuss those risks and alternative treatments with patients. (RELATED: FDA proposes checklist to inform patients of LASIK surgery risks, Regulatory Focus 28 July 2022)
FDA extended the comment period in response to requests from several stakeholders; so far the agency has received more than 600 comments to the docket.
In their public comments, industry groups AdvaMed and the Medical Device Manufacturers Association (MDMA) have asked FDA to withdraw the guidance, saying it amounts to interfering with clinical interactions between physicians and patients, and in effect would regulate the practice of medicine.
“The draft guidance intrudes on the patient informed consent process for the LASIK procedure – informed consent related to medical procedures is solely in the purview of clinicians and/or their associated health care facilities,” said AdvaMed. “Although it is unclear, it appears that FDA is aware that the proposed patient labeling in the draft guidance may, in effect, dictate medical practice but nevertheless chose to issue the draft guidance.”
AdvaMed also said the manufacturers should not have to make labeling that includes a checklist of alternative and competing treatments.
“This seems to be squarely within the surgeon’s responsibility, who can and should discuss the details of why certain treatments are appropriate or inappropriate based on the specific characteristics of a particular patient’s eye(s) or vision,” they added.
AdvaMed said that instead of issuing the guidance, FDA should collaborate with ophthalmic medical societies such as the American Academy of Ophthalmology and the American Society of Cataract and Refractive Surgery to gather the latest data on LASIK treatments and develop preferred practice pattern (PPP) guidelines that can help with standard of care.
“If the FDA believes that an FDA guidance directed to industry, rather than a preferred practice pattern, is warranted, it should open a new docket, separate from the draft guidance, for public comment, or convene an Ophthalmic Devices Panel meeting, in order to obtain up-to-date input for the formal record,” the group added.
Several stakeholders, including MDMA note that the guidance relies on information from a 2008 panel FDA convened on the topic and additional data from 2009, which do not take into account improvements to LASIK technology since then.
“Moreover, the Draft Guidance oversteps the scope of the FDA’s regulatory authority and contradicts the agency’s long-established regulatory approach, by impermissibly regulating the practice of medicine,” said MDMA. “As the FDA has long acknowledged, the agency does not regulate the practice of medicine, including informed consent obtained by physicians prior to engaging in a procedure with a particular patient.”
While the group said they agree that patients should be appropriately informed in their best interest, they don’t think the guidance achieves that objective and should be withdrawn.
Daniel Cameron, the Republican attorney general for Kentucky, also wrote to FDA, arguing its guidance is an infringement on state authorities. He said the agency does not have authority to preempt a state’s informed consent laws unless Congress gives it that explicit ability.
“In the medical device context, Congress has said that no state may establish any requirement that is different from or in addition to any applicable federal requirement,” said Cameron. “In most cases a state law will be preempted only to the extent that the FDA has promulgated a relevant federal
requirement.”
The Kentucky AG also raised concerns that FDA is creeping toward regulating medical practice under the guise of attempting to shape the informed consent process. He pointed to a September 2020 guidance entitled, Breast Implants – Certain Labeling Recommendations to Improve Patient Communication, in which the agency similarly recommended incorporating a boxed warning and establishing a patient decision checklist into the product label.
“This seems to be squarely within the surgeon’s responsibility, who can and should discuss the details of why certain treatments are appropriate or inappropriate based on the specific characteristics of a particular patient’s eye(s) or vision,” they added.
AdvaMed said that instead of issuing the guidance, FDA should collaborate with ophthalmic medical societies such as the American Academy of Ophthalmology and the American Society of Cataract and Refractive Surgery to gather the latest data on LASIK treatments and develop preferred practice pattern (PPP) guidelines that can help with standard of care.
“If the FDA believes that an FDA guidance directed to industry, rather than a preferred practice pattern, is warranted, it should open a new docket, separate from the draft guidance, for public comment, or convene an Ophthalmic Devices Panel meeting, in order to obtain up-to-date input for the formal record,” the group added.
Several stakeholders, including MDMA note that the guidance relies on information from a 2008 panel FDA convened on the topic and additional data from 2009, which do not take into account improvements to LASIK technology since then.
“Moreover, the Draft Guidance oversteps the scope of the FDA’s regulatory authority and contradicts the agency’s long-established regulatory approach, by impermissibly regulating the practice of medicine,” said MDMA. “As the FDA has long acknowledged, the agency does not regulate the practice of medicine, including informed consent obtained by physicians prior to engaging in a procedure with a particular patient.”
While the group said they agree that patients should be appropriately informed in their best interest, they don’t think the guidance achieves that objective and should be withdrawn.
Daniel Cameron, the Republican attorney general for Kentucky, also wrote to FDA, arguing its guidance is an infringement on state authorities. He said the agency does not have authority to preempt a state’s informed consent laws unless Congress gives it that explicit ability.
“In the medical device context, Congress has said that no state may establish any requirement that is different from or in addition to any applicable federal requirement,” said Cameron. “In most cases a state law will be preempted only to the extent that the FDA has promulgated a relevant federal
requirement.”
The Kentucky AG also raised concerns that FDA is creeping toward regulating medical practice under the guise of attempting to shape the informed consent process. He pointed to a September 2020 guidance entitled, Breast Implants – Certain Labeling Recommendations to Improve Patient Communication, in which the agency similarly recommended incorporating a boxed warning and establishing a patient decision checklist into the product label.
Cameron said that once the breast implant guidance was finalized, FDA issued an order that restricted sale of breast implants only to health care providers and facilities that provided information to patients using a patient decision checklist. That, in effect, converted a recommendary guidance into a mandate, he said.
“As the FDA repeatedly states, the draft guidance is not a requirement, and it is a non-binding recommendation even if made final,” said Cameron. “Therefore, the guidance cannot be treated as ‘specific federal requirements’ that would preempt state requirements. This would be true even if the FDA later issued an order restricting the sale or use of lasers to doctors who comply, because, as discussed above, such action would be an impermissible attempt at circumventing the limits on the FDA’s authority.”
The Society for Excellence in Eyecare (SEE) also asked FDA to withdraw the guidance stating it exceeds its authority and is based on outdated information. The group notes that FDA lists several contraindications in the guidance but since the data was acquired LASIK technology has gotten better and many of the side effects listed by the agency are temporary which fails to consider the potential long-term benefits compared to short-term issues such as dry eyes, discomfort and blurred vision.
“It is not unusual for patients to have some mild discomfort right after LASIK, but it usually goes away within a few weeks or months,” said SEE.
In the guidance, FDA noted that certain complications such as dry eye, inflammation or infection may cause severe, constant pain in some patients, preventing them from doing their normal activities. In some patients, it states the pain may never go away and may be resistant to therapy.
SEE argues the agency is conflating the normal healing process after LASIK surgery with neuropathic pain. The group argues that neuropathic pain resolves with treatment.
But not everyone was against FDA’s draft guidance. The American Optometric Association (AOA) said the guidance was “timely and beneficial” in providing patients with transparency around the risks and benefits of LASIK devices. The group asked for some changes to the guidance, including the inclusion of pregnancy as a contraindication and contact lenses as required devices that may result from LASIK surgery complications.
The AOA also asked FDA if it intends to publish a similar guidance on photorefractive keratectomy (PRK).
“As the FDA repeatedly states, the draft guidance is not a requirement, and it is a non-binding recommendation even if made final,” said Cameron. “Therefore, the guidance cannot be treated as ‘specific federal requirements’ that would preempt state requirements. This would be true even if the FDA later issued an order restricting the sale or use of lasers to doctors who comply, because, as discussed above, such action would be an impermissible attempt at circumventing the limits on the FDA’s authority.”
The Society for Excellence in Eyecare (SEE) also asked FDA to withdraw the guidance stating it exceeds its authority and is based on outdated information. The group notes that FDA lists several contraindications in the guidance but since the data was acquired LASIK technology has gotten better and many of the side effects listed by the agency are temporary which fails to consider the potential long-term benefits compared to short-term issues such as dry eyes, discomfort and blurred vision.
“It is not unusual for patients to have some mild discomfort right after LASIK, but it usually goes away within a few weeks or months,” said SEE.
In the guidance, FDA noted that certain complications such as dry eye, inflammation or infection may cause severe, constant pain in some patients, preventing them from doing their normal activities. In some patients, it states the pain may never go away and may be resistant to therapy.
SEE argues the agency is conflating the normal healing process after LASIK surgery with neuropathic pain. The group argues that neuropathic pain resolves with treatment.
But not everyone was against FDA’s draft guidance. The American Optometric Association (AOA) said the guidance was “timely and beneficial” in providing patients with transparency around the risks and benefits of LASIK devices. The group asked for some changes to the guidance, including the inclusion of pregnancy as a contraindication and contact lenses as required devices that may result from LASIK surgery complications.
The AOA also asked FDA if it intends to publish a similar guidance on photorefractive keratectomy (PRK).
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