The QMN Weekly Bulletin

FDA Lifts Hiring Freeze, Gottlieb Discusses Device Safety

June 2, 2017

FDA Commissioner Scott Gottlieb drew questions from lawmakers on device approvals as he laid out his early priorities in a House appropriations hearing Thursday, and announced that the hiring freeze on the agency had officially been lifted.

Gottlieb told members of the House Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies that he had notified the agency’s senior staff of the thaw in a memo earlier that morning.

President Trump signed an executive order in January implementing the hiring freeze for all federal agencies. The freeze was lifted by the Office of Management and Budget April 12, but was maintained by HHS, with restrictions based on the administration’s planned cuts for the FDA and other agencies. Previously, medical officer positions had been exempted.

Members of Congress had repeatedly inquired about the effects of the hiring freeze on the FDA, and whether it would slow the implementation of the 21st Century Cures Act and user fee programs.

Rep. Rosa DeLauro (D-Conn.) and other lawmakers quizzed the commissioner on recent device recalls and his plans for speeding up the device approval process without compromising quality and safety—which she said is already questionable.

On the issue of “speed versus safety,” Gottlieb said he has no interest in compromising quality, efficacy or safety in the name of faster approvals.

He said the agency instead needs to focus on efficiencies in the development process — which would ultimately lead to lowering the cost of device development and the finished products — by asking the right questions on the development end, and by providing the right guidance, rules and scientific tools to make sure it’s “not only efficient but also learning all we can during that process about safety and efficacy.”

The administration’s proposed $5.1 billion fiscal 2018 FDA budget would cut the agency’s taxpayer-funded budget authority by $854 million and make up for it by dramatically increasing industry-paid user fees—a move FDA and drug industry experts say would harm the agency.

Medical device design is linked inextricably with risk management. Risk reduction measures become design inputs. Implementation verification, a risk management activity, can work as design verification too. Better design and smoother operations benefit everyone — your employer, your customers, maybe your paycheck too. It’s well worth 90 minutes out of your week to sharpen skills and increase professional standing. Learn more with Device Design and Risk Management.

View today's stories