To Ease the Regulatory Process, Improve Your Ability to Think Like FDA

Kenneth Sumner, PhD, vice president, worldwide scientific affairs for Ethicon Endo-Surgery Inc. spoke a couple of weeks ago at the at the Life Sciences Summit in Mountain View, CA, where he talked about his company's approach to dealing with regulatory affairs. Sumner said that Johnson & Johnson has the luxury of being a champion for the medical device industry. But he also stresses the importance of being respectful of FDA and to approach them humbly. “If you want to commercialize product in the United States, FDA is the only way to do it. And whatever you think of FDA, it doesn’t matter,” he says. “They own the ball the bat, the rules, everything.”

He went on to explain that, before meeting with representatives from the agency, it is helpful to try to put yourself in their shoes. 

He recommended asking questions such as: 

“We’ve found in a couple of recent meetings that this idea of understanding FDA does resonate very well with them,” he says. “And so we are trying to get back to that understanding because we know if we’re going to sell product in the United States, it’s FDA that we have to work with.”

Sumner also explained that his company, which is a subsidiary of Johnson & Johnson, has been corresponding with FDA on recent draft guidance. “We’re actively working as Johnson and Johnson to reply to those, analyze them, and put together feedback to the FDA to help them understand what the effect of these draft guidances are on [medtech] companies,” he said.

—Brian Buntz