Sunday, September 20, 2009

I was recently sent this article posted below from an eye care practice. As someone that is very tuned in with eye care advertising we are always interested in helping others understand compliance. Glacial Multimedia Inc. has always been dedicated to following advertising guidelines. With the pressure to produce sales in this tough economy it is no wonder why practices resort to inappropriate techniques, but we all must remember we are medical industry professionals. This applies to LASIK marketing agencies, LASIK eye care web development companies, consultants, manufacturing companies, and certainly eye care practices.

Using misleading advertising does not help eye care professionals in the long-term perspective. Misleading patients through advertising can be very dangerous and lead to unnecessary lawsuits. However, everyday we still see advertising misleading patients, giving lead referral bonuses, claiming PRK is bladeless LASIK, using inaccurate technology claims and making un-realistic success statements. I have posted a copy of this letter from the FDA on our website because I feel it is important to spread this message to the eye care community of physicians, and related companies.

FDA Letter to Eye Care Professionals 

Dear Eye Care Professional:
 
The Food and Drug Administration (FDA) is writing to provide you with important information about the promotion and advertising of FDA-approved lasers that are used during laser-assisted in-situ keratomileusis (LASIK) procedures and to let you know where you may get additional information, if needed.

The FDA's Ophthalmic Devices Panel held a public meeting to discuss issues concerning post-market experiences with LASIK procedures. Both at the meeting and through submissions to a subsequently established public docket, the FDA has received information, comments, and complaints from interested persons regarding the promotion and advertising of LASIK procedures and the FDA-approved lasers used in LASIK procedures. The FDA has received complaints that eye care professionals' advertisements for LASIK procedures and FDA-approved lasers used for the LASIK procedures failed to inform consumers of the indications, limitations, and risks associated with LASIK procedures and the approved lasers used for the LASIK procedures.
 
The FDA believes that eliminating deceptive or misleading health-related advertising claims is an important part of protecting the public health. The FDA has approved several lasers intended for use in LASIK procedures. A list of all FDA-approved lasers for LASIK procedures may be found at: Devices@FDA. This Web page also provides information about the scope of the intended uses for each FDA-approved, restricted device and the risks associated with the use of the device. The information about risks may include warnings, precautions, side effects, and contraindications.
These lasers are restricted medical devices that have been approved for particular uses and have risks associated with their use. Advertising and promotional materials for FDA-approved lasers used during LASIK procedures must be truthful, properly substantiated and not misleading.
 
A restricted device is misbranded under the Federal, Food, Drug, and Cosmetic Act (Act) if its advertising is false or misleading (21 U.S.C. 352(q)). In determining whether the advertisement is misleading, the FDA takes into account not only representations made or suggested by statement, word, or design, but also the extent to which the advertisement fails to reveal facts material in the light of such representations, or material with respect to consequences which may result from the use of the device to which the advertisement relates under the conditions of use prescribed in the advertisement (21 U.S.C. 321(n)).

If you become aware of an advertisement for any of these restricted devices that may be in violation of the Act, please forward it to FDA's Center for Devices and Radiological Health (CDRH), Office of Compliance at the address listed above. Questions concerning this letter may be directed to Ann Simoneau, Regulatory Counsel, CDRH, Office of Compliance at (301) 796-5514.
 
Sincerely yours,
Timothy A. Ulatowski
Director
Office of Compliance
Center for Devices and
Radiological Health

Posted By Michael Dobkowski at 05:18 AM