05292017Headline:

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Greg Webb
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FDA Scolds Eye Care Health Professionals About False Claims

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Last week the U.S. Food and Drug Administration (FDA) issued a "Letter to Eye Care Professionals" with a broad warning against "deceptive, potentially harmful advertising" that makes false claims, and putting them on notice that they have 90 days within which to update their advertising to reflect more accurate claims. After the 90-day honeymoon period, the FDA will "take regulatory action." If a company has "unproven claims, important omissions or claims of complete safety" that may not fully exist, there will surely be trouble, implied Erica Jefferson, FDA spokesperson.

Eye care professionals must have reasonable bases for the claims they make in their advertising. In its 2008 guidance to eye care doctors, the Federal Trade Commission (FTC) states that endorsements by satisfied customers (patients) are not enough to make an objective evaluation of a health or safety claim. While some advertisements are accurate, they don’t always provide the complete truth. If a procedure is stated as "clinically proven to be safe", there should be supporting data for that claim.

American Society of Cataract and Refractive Surgery representative, Dr. Eric D. Donnenfeld, says his group is in favor of FDA’s efforts to clean up misleading advertising by eye care professionals. "LASIK is exceptionally safe when done by the right doctor on the right patient." Choosing the correct physician is a burden on the patient and a decision which definitely makes a difference in the outcome of complicated eye care procedures. Choosing a physician solely based on advertisements in the media, according to Donnenfeld, is not be the best way of selecting one’s doctor. Although procedures such as LASIK have improved tremendously in the past few years, certain patients may be less than glowing candidates for some procedures—and there are always risks which should be discussed by the eye care professional with the patient ahead of a procedure, when possible.

In any case, eye care professionals have 90 days to clean up their advertising act. If you are considering such surgery, do your homework on the procedure and the professional(s) performing the procedure.