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Pitts, Upton Push to Ease Delays in Medical Device Regulatory Process to Benefit Patients, Spur Job Growth


WASHINGTON, DC – The House Energy and Commerce Health Subcommittee, chaired by Rep. Joe Pitts (R-PA), today held a hearing to examine the impact of medical device regulations on patients and jobs. During the hearing, members of the subcommittee questioned the Food and Drug Administration’s Center for Device and Radiological Health Director Jeffrey Shuren about recent reports that small businesses and device companies are being forced to market their devices first in Europe because the EU countries have a more predictable and consistent regulatory process.

“Multiple studies have shown that regulatory uncertainty is damaging this critical industry and hurting American patients,” said Pitts. “According to a recent report from Pricewaterhouse Coopers, the FDA process is “˜unpredictable and characterized by disruptions and delays.’  Quite simply, shorter, more predictable, and more transparent approval processes in Europe have led many device companies to seek a market for their products in Europe before submitting them to the FDA. We need to ensure that our regulatory system is consistent and transparent so American patients have timely access to life-saving and life-improving drugs and devices and American workers have access to these good jobs.”

Energy and Commerce Chairman Fred Upton (R-MI) said, “We need to get Americans back to work. Part of that involves fixing regulatory problems caused by the federal government. Our nation has been the world leader on medical devices, using American innovation to bring life-saving, life-improving devices to American patients and create high-paying, rewarding jobs here at home.  Unfortunately, our leadership is being threatened.  FDA must build certainty, predictability and transparency into its process so our nation can stay as the global leader in medical device innovation, so we can create good-paying jobs here at home and so we can improve the lives of patients.”

ExploraMed Development CEO Josh Makower and The Foundry Managing Partner and Chief Technology Partner Mark Deem also appeared before the subcommittee and testified that current FDA regulations slow growth, delay job creation, and expansion.

Makower said, “I am deeply concerned that we are in jeopardy of losing the US leadership position in medical technology innovation as a result of the current regulatory environment at FDA.  Over the past several years it has been increasingly difficult, more time consuming, more costly and less predictable to navigate the FDA approval process.  As a result, investment is drying up, companies are moving overseas or closing their doors and US patients are being denied timely access to safe and effective new medical products.”

“I am speaking to you today because those of us who operate on the most fragile end of the medical device ecosystem, the startups, are struggling.  Startups are responsible for a huge percentage of paradigm-shifting breakthroughs in patient care. We exist for our patients, but we live on venture capital,” explained Deem.

In response to a question by Rep. Brett Guthrie (R-KY), both Deem and Makower shared concern over the medical device tax instituted in the recent health care law.  Deem testified that companies have already delayed hiring in anticipation of the tax and Makower requested Congress modify the tax proposal.


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