Give FDA Authority over All Medical Device Ads? By Jim Dickinson
Historically, U.S. law has given the Federal Trade Commission (FTC) primary authority to regulate the advertising and other promotion of prescription medical devices not otherwise "restricted" by FDA.
Restriction most commonly occurs in the conditions of approval stipulated in writing by FDA at the time of PMA approval, leaving the overwhelming majority of Class I and II devices unrestricted and therefore subject only to FTC, and thus scant, regulation of their advertising and promotion.
This is in stark distinction to other FDA-regulated prescription medical products, primarily drugs and biologics, which are unequivocally regulated in their promotional activities by FDA.
In practice, this has meant that the advertising and promotion of prescription drugs and biologics have been much more closely regulated than the marketing claims commonly made for most medical devices.
Lacking the in-house scientific backup that FDA has, FTC's interest in medical devices has been minimal, a neglect that many Washington device lawyers justify by citing a fundamental difference between devices and drugs: the former's characteristic ongoing and frequent design and materials change throughout the product life cycle, versus the latter's static adherence to the formula, ingredients and indications as approved by FDA.
Arguments that there should be a public safety-based regulatory consistency for both categories of medical products frequently get short shrift from legal scholars.
But consider the case of hyper-advertised LASIK excimer lasers, which are "unrestricted" Class III devices and are therefore in FTC's regulatory bailiwick, where they enjoy an unrestricted advertising world of bright-eyed people who've thrown away their glasses forever after what the ads portray as a quick and easy, painless procedure with a high-tech laser.
Article continued at LasikNewswire.