Copyright Dickinson FDA Webview at www.fdaweb.com. Republished by permission.
8/2/2014

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.

If you listen to CDRH former CDRH Diagnostic and Surgical Devices branch chief Morris Waxler, who approved the LASIK devices and Harvard assistant clinical ophthalmology professor Perry Rosenthal, who has studied their effects, you’ll glimpse the dark underbelly of FDA and FTC regulatory negligence. Here there’s an alleged LASIK adverse event rate that’s 20 times higher than FDA accepted when it approved the LASIK indication, and industry-dependent professional ophthalmology journals that reject papers trying to draw attention to it.

LASIK (laser in-situ keratomileusis) is a popular in-office procedure in which a U-shaped flap is cut by microkeratome blade in the surface of the cornea over the iris, the underlying stroma is contoured with an excimer laser, and the flap then folded back in place. However, untold to patients, the flap never heals, and is always prone to dislodgement and infection in such violent activities as contact sports and accidental trauma.

Waxler, who led the review team that approved the first of these lasers for LASIK in the late 1990s, was content with the decision until 2004, when a volatile and outraged Florida microjet salesman, Dean Kantis, tracked him down, now retired in Madison, Wisconsin.

Kantis operates a flamboyant Web site and belongs to country-wide networks of other injured LASIK patients. All allege they had received no FDA-required patient informed consent, namely the agency’s approved product-specific patient information brochure. LASIK surgeons do not answer to FDA because medical practice is regulated at the state level.

Kantis connected Waxler to other injured patients around the country. At first the retired FDA veteran was wary, but he gradually became sufficiently intrigued to begin personally researching the stories of the severely injured LASIK patients (including the mother of patient she said committed suicide due his LASIK injuries) and re-analyzing the industry-submitted PMA data on which he had relied to approve the devices. After five years in this effort, Waxler petitioned FDA in 2011 to withdraw the devices’ LASIK indication and issue a public health advisory.

Waxler’s conclusion: to get PMA approval, the laser makers had submitted fraudulent data to FDA attesting to a less-than-one-percent incidence of post-LASIK adverse events. Waxler’s re-examination of the PMA data revealed an incidence of more than 20 percent.

On this basis, the other 80 percent have no post-surgery problems, thus explaining, in part, the paucity of public complaints. Also the same devices have therapeutic, non-LASIK uses that are uncontroversial.

Meanwhile, Harvard Medical School assistant clinical professor of ophthalmology Perry Rosenthal had come to a parallel conclusion about the hidden LASIK adverse events.

Rosenthal identified and studied 21 patients who developed “unrelenting agonizing” eye pain following LASIK surgery, pain that had persisted for 2-15 years at the time of the study. He found that their pain was so “devastating and resistant to treatments that most of these patients admitted to thoughts of suicide.”

Rosenthal also discovered that the onset of this “neuropathic” eye pain was delayed in the majority of these patients, sometimes for many years after their eyes had healed and were comfortable. This type of pain had not been reported in the medical literature and because these eyes typically looked normal the sufferers had been accused of exaggerating or fabricating their suicide-provoking pain.

Nevertheless, his paper detailing these findings was rejected by two peer-reviewed ophthalmology journals and Rosenthal says he was forced to post it on his nonprofit Web site to avoid it being buried. He estimates there are 800,000 LASIK procedures every year worldwide and the available pool of surgical candidates is growing by 2 million eyes per year.

Rosenthal’s next step was to send his paper to FDA, despite being warned that the agency would not respond. FDA not only blew off Rosenthal’s study, it also blew off Waxler’s petition, just as it had previously blown off Kantis’ angry and insulting tirades (“Go to FTC,” it told him, but he found that agency to be just as disinterested as FDA).

After a 30-month wait, this past June Waxler received FDA’s formal denial of a petition he had filed seeking removal of the LASIK indication from all excimer lasers.

On July 22, he plunged onward, filing a petition for reconsideration in which he charged that FDA “grossly underestimates the risks of LASIK by conflating data used to legally support the PMAs with LASIK industry information used to promote sales.”

In doing so, he wrote, CDRH had sent two messages: that the LASIK industry could feel secure because “the agency has your back,” and that the public should beware because “FDA does not have your back.”

Waxler told the agency that it had “made deals” with the LASIK industry that “degraded the scientific quality of the collection and analysis of adverse event data of LASIK devices.”

He listed alleged deals with the following entities: Kremer Laser, American Society for Cataract and Refractive Surgery, CRS Inc., and more than 100 user facilities that he says received IDEs “to study LASIK in order to minimize their exposure to violating off-label rules.”

Would giving CDRH the authority to regulate all medical device advertising change its subservience to industry?

The only model we have is the more tightly regulated market environment for prescription drugs and biologics at CDRH’s sister Center for Drug Evaluation and Research (CDER), where historically promotional activities have been strenuously regulated. CDRH has a staff of three to review restricted device promotional activity, while CDER boasts a staff of 60 for this kind of work.

Medical device lawyers and proponents abhor the prescription drug regulatory template for the industry’s products, and the 1976 Medical Device Amendments and subsequent legislation have been careful to avoid such an imposition.

But when it comes to marketing and advertising at least, the LASIK experience gives us pause.