9/9/2015

Copyright Dickinson FDA Webview at www.fdaweb.com. Republished by permission.

Despite continued agitation on the part of patient activists claiming injuries from LASIK vision correction procedures, FDA said 9/9 it has “not found any new safety concerns associated with LASIK devices to lead it to believe that there is no longer a reasonable assurance that these devices are safe and effective under the conditions of use in the labeling of the device.” The statement came after FDA Webview asked why the agency had not responded to a 5/8 letter from LASIK activist Paula Cofer to acting commissioner Stephen Ostroffthat attached 1,073 electronic signatures supporting reconsideration of FDA’s denial of a LASIK ban petition from former CDRH ophthalmic devices chief Morris Waxler.

Cofer herself chided Ostroff for his non-response in a second letter attaching an investigative report in the September issue of Consumers Digest and advising him that two more ex-FDA officials are now speaking out against LASIK: Former CDER ophthalmic division deputy director Everett Beers, quoted in Consumers Digest as supporting Waxler’s assertion that LASIK should not have been approved, and former medical device compliance director Larry Pilot, quoted in the same article as saying, “When it comes to LASIK, it isn’t that the agency has dropped the ball, it’s that they never even moved it.”

Cofer’s second letter to Ostroff told him: “For years we’ve been complaining to the FDA about this issue. In 2008 your agency said you would reevaluate the safety of LASIK. It’s been seven and one-half years, and nothing has changed except for the growing number of injured LASIK patients. Now it’s your watch, Dr. Ostroff. Are we to expect more of the same treatment ─ injured citizens shut out of the regulatory process? Or will you do what’s right and respond to our grievances and concerns?”

FDA’s response to FDA Webview said the agency entered Cofer’s 5/8 letter to Ostroff as a public comment to the docket to Waxler’s 7/22/14 petition for reconsideration, and the agency’s failure to notify her of this was an “oversight.” As for Cofer’s latest letter, “it is currently under review. The FDA will respond directly to Ms. Cofer if necessary.”