Week in Review, December 16, 2014

Otismed pleads guilty to selling knee replacement cutting guides that had been rejected by the FDA, Senators Hatch and Bennett introduce bill to exempt low risk software from the definition of a medical device, and the oversight group for the APBI Code of Conduct chastises Galderma over the requirements for attending a presentation.

They litter the landscape of the Christmas season, and have become so iconic that an entire day is dedicated to celebrating the infamous ugly Christmas sweater. It’s as much a fixture of the season as Santa hats and reindeer antler headbands. In fact, a number of on-line retail outlets have jumped on the bandwagon for this haute mess couture. Before we get dive into a debate over the categorization of light-up sweaters as “ugly” or just a “whole separate item,” we’ll dive into something a little less controversial, this week’s Compliance News in Review.

This isn’t a warm and cozy situation for Otismed and its former CEO. The company pleaded guilty to criminal and civil charges that it sold knee replacement surgery cutting guides despite it being rejected by the FDA. According to prosecutors, the former executive directed that over 200 of units be shipped despite the product not receiving FDA clearance and the company’s board voting to cease shipments of the product. Otismed was purchased by Stryker, which was unaware of the incident at the time of purchase. The company will pay $80 million to resolve the charges and the former CEO will be sentenced in March of 2015.

There are no ugly feelings from med tech innovators about a bill recently introduced in the U.S. Senate. Senators Orin Hatch and Michael Bennett have introduced a bill that will exempt low-risk medical software and apps from the definition of a medical device under the FDCA. The senators say the bill will provide clarity over which devices should be regulated. The bill, called the MEDTECH Act, removes five categories of innovation from the definition of a covered device.

Could the Prescriptions Medicines Code of Practice Authority (PMCPA) be unraveling its ties with Galderma? PMCPA, the oversight group for the Association of the British Pharmaceutical Industry’s Code of Practice, and Galderma are at an impasse over a public reprimand issued against the company by the organization. The reprimand stems from a complaint lodged by a nurse attending an educational meeting sponsored by Galderma. The complaint alleges that attendees had to prove they had purchased the company’s filler in order to attend the presentation. In addition, the PMCPA says attendees received financial incentive to attend in the form of free product. Galderma says it was not uncommon to require attendees to purchase product in order to attend, and the filler is a medical devices so any related activities do not fall under the Code. Galderma appealed the decision, and the PMCPA has removed the company from its list of companies agreeing to abide by the Code.

With that, we put a wrap on this week’s edition of the News in Review. Good luck with those ugly sweater contests this weekend everyone, and remember, light-up reindeer noses always seem to catch the judge’s eyes.

Have a great week!

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