Updated LASIK Advertising Guidelines Posted by Food and Drug Administration (FDA)
On Monday, the FDA circulated another letter to ASCRS and the American Academy of Ophthalmology (AAO) providing additional information about disclosing risk information in eye-care professionals' advertisements and promotional materials concerning FDA-approved lasers intended for LASIK. Due to various requests that they received from individual practices, etc., the FDA posted on their website the risk information that they believe should be included in all LASIK marketing and advertisements.
Specifically, the risk information that is on all FDA-approved labeling for all lasers, which includes the "risks of dry eye syndrome, which can be severe; the possible need for glasses or contact lenses after surgery; visual symptoms including halos, glare, starbursts, and double vision, which can be debilitating; and the loss of vision," should be included.
The letter is a follow up to two previous FDA letters dated September 2011 and May 2009. The letters are in response to information received at an April 2008 Ophthalmic Devices Panel public meeting that "eye-care professionals” advertising and promotion often failed to properly inform consumers of the indications, limitations, and risks of refractive procedures and the lasers used for those procedures."
The FDA noted that any corrections should be made within 90 days to avoid regulatory action.
Questions can be directed to Jenny Liljeberg, associate director of regulatory affairs, at jliljeberg@ascrs.org.
ASCRS, in Conjunction with Alliance of Specialty Medicine, Submits Comment Letter on FDA Guidance on Unsolicited Requests for Off-Label Information
On Thursday, March 29, in conjunction with the Alliance of Specialty Medicine, ASCRS submitted a comment letter to the FDA in response to the draft guidance released by the Agency in December, 2011, Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices. While FDA recognizes that health-care professionals can lawfully use FDA products for off-label uses or treatment regimens, in the draft guidance the FDA states that physicians speaking in a Speaker’s Bureau, firm-sponsored webinar, engagements (or other firm sponsored event) are prohibited to respond to any off-label question from audience participants. The speaker would have to cease all discussions (“thank you for the off-label question…”) and refer that person to the firm’s Medical or Scientific Department for a written response.
ASCRS and the Alliance’s comments focus on protecting the value of physician’s ongoing education; specifically, raising concerns with the proposed policy for handling public unsolicited requests that overly restricts the ability of any physician to openly discuss and respond to questions about off-label uses of drugs and devices in an educational public forum with their colleagues, as is the current custom. The letter requests that the draft guidance be amended to remove the new restrictions and continue to allow physicians to respond to their colleagues at industry-sponsored events regarding off-label information.
