Copyright Dickinson FDA Webview at www.fdaweb.com. Republished by permission.
01/04/2017

(Report by Jim Dickinson) FDA has statutory authority to regulate the advertising and promotion of “restricted” medical devices, but even in the face of injured patient complaints, it’s an authority it rarely uses. That’s probably because in the broad sweep of device safety issues and recalls that grab headlines and congressional attention, complaints about ads from injured patients directly to the agency’s Center for Devices and Radiological Health are few and far between. And that’s probably because injured patients don’t know that CDRH is supposed to be regulating violative device ads.

One injured patient, however, does know and in November she complained to CDRH about a violative ad by LASIK (laser-assisted in-situ keratomileusis ) eye surgeon T. Hunter Newsom, in Tampa, FL. A former FDA advisory committee consumer member, injured Tampa LASIK patient Paula Cofer complained that Newsom’s Web site omitted all risk information in extolling the benefits of his new Wavelight laser by Alcon Laboratories. CDRH regulatory counsel Deborah Wolf responded that she’d referred the complaint to the Allegations of Regulatory Misconduct Branch, with the suggestion that Cofer communicate directly with them.

When Cofer did so, she got an email form letter saying “FDA does not provide information on ongoing investigations. Such information can be obtained pursuant to a Freedom of Information Act (FOIA) request once an investigation is closed … Please note that on average, investigations take a minimum of six (6) months to complete.” There was no information on how Cofer could learn of the investigation’s completion, other than the unsaid implication that she could begin inquiring on her own schedule after the minimum six months.

For the FDA-savvy Cofer, this was “Unbelievable!” For injured patients without FDA familiarity it would likely be plain impossible, given (a) their unawareness that FDA even has a role in false or misleading medical device promotional claims enforcement, and (b) their inability to discover who at FDA might handle such complaints.

There was a time when CDRH took this issue a little more seriously than it does now. In September 2011, hard on the heels of an acrimonious campaign by injured LASIK patients against LASIK surgeons’ violative promotions, then-CDRH compliance director Steven Silverman issued a Dear Eye Care Professional letter politely urging them to be mindful of the law. In it, he reminded them that this was the second time in two years that FDA had taken this direct approach to their promotional practices. He gave them 90 days to comply with the law.

“After that time,” Silverman wrote, “the FDA may take regulatory action against eye care professional whose advertisements or promotional materials violate the FD&C Act. Agency actions may include Warning Letters, product seizures, injunctions and civil money penalty proceedings.”

Actually, this was CDRH’s third attempt to bring the LASIK practitioner community into compliance. The Center sent a similar letter separately to the community’s national body, the American Society of Cataract and Refractive Surgery.

Cofer and the earlier prolific complainers among the LASIK injured patient community say these efforts had no effect on the number of deceptive promotions and advertising by practitioners. Indeed, since Cofer complained about Newsom, she says she has found three additional active violative Web sites belonging to the 37-state, 68-center LASIK Vision Institute, California-based Saroudi Advanced Lasik and Eye Centers, and surgeon Manoj Motwani.

For ongoing and proliferating violations dating back more than seven years, why doesn’t FDA do more than say it can’t confirm or deny the existence of its investigations and invite FOIA requests after an investigation is complete? Probable explanations include ꟷ if the agency allowed itself to publicly discuss the matter: (1) Lack of resources to prosecute so many cases which have comparatively few reports of actual harm; (2) the agency’s dismal track record in court cases involving First Amendment issues (which LASIK surgeons would surely invoke if prosecuted); (3) the need to defend its failure to aggressively address the related issue of permanent eye injuries in a small minority of LASIK patients who were deceived; and (4) lack of congressional and media interest.

While LASIK may be dismissed as an isolated case because of its elective nature, other areas of violative promotional activity among users of restricted devices may be encouraged by its example. That’s a bet FDA appears to be confident in making.