Shuren endures criticism of FDA review process
Jeffrey Shuren, MD, JD, director of the FDA's Center for Device and Radiological Health, heard testimony from patients and device innovators who were critical of medical device review procedures, during a July 20 meeting of the House Energy and Commerce Subcommittee on Oversight and Investigations.
Shuren testified that the FDA is refining its approval methods and attempting to identify rules that may be obsolete. He noted that in April, the agency requested comment on any rules that might fit into that category, and also cited recent draft guidance that describes the agency's intent to exercise enforcement discretion with certain device approval procedures.
Among some of the speakers, Carol Murphy, a migraine sufferer from Fairborn, Ohio, testified that the FDA’s approval process has prevented American patients from using medical equipment that relieves migraine symptoms. “We, as Americans, should not have to go to England to get medical equipment to help live a normal life,” she said. “This is a product made in America, by Americans, but not for use by Americans.”
Medical device inventor Robert E. Fischell, ScD, was also critical, calling the current regulatory environment “the worst” he has experienced in a 42-year career developing medical technologies. “Unfortunately, it is not technology, science, ingenuity or the economy that is standing in the way of success in developing new medical technologies. It is the FDA,” Fischell said.
Shuren testified that the agency is identifying rules that are “obsolete, unnecessary, unjustified, excessively burdensome or counter-productive,” and the FDA is updating existing regulations as well—including instituting an electronic Medical Device Reporting system, reforming regulatory initiatives, as well as defining its role in patient safety regulation.
“As we continue to look for ways to improve our ability to facilitate innovation and to speed safe and effective products to patients, we must not lose sight of the benefits of smart regulation, to the industry, patients, and society. Medical device regulation results in better, safer, more effective treatments and worldwide confidence in, and adoption of, the devices that industry produces,” Shuren said.
“I share your goal of smart, streamlined regulatory programs," Shuren told the chair and members of the subcommittee. "The Department’s plan for regulatory reform under President Obama’s Executive Order will heighten and maintain the focus on this important prinicipal.”
Shuren's testimony can be found here.
Shuren testified that the FDA is refining its approval methods and attempting to identify rules that may be obsolete. He noted that in April, the agency requested comment on any rules that might fit into that category, and also cited recent draft guidance that describes the agency's intent to exercise enforcement discretion with certain device approval procedures.
Among some of the speakers, Carol Murphy, a migraine sufferer from Fairborn, Ohio, testified that the FDA’s approval process has prevented American patients from using medical equipment that relieves migraine symptoms. “We, as Americans, should not have to go to England to get medical equipment to help live a normal life,” she said. “This is a product made in America, by Americans, but not for use by Americans.”
Medical device inventor Robert E. Fischell, ScD, was also critical, calling the current regulatory environment “the worst” he has experienced in a 42-year career developing medical technologies. “Unfortunately, it is not technology, science, ingenuity or the economy that is standing in the way of success in developing new medical technologies. It is the FDA,” Fischell said.
Shuren testified that the agency is identifying rules that are “obsolete, unnecessary, unjustified, excessively burdensome or counter-productive,” and the FDA is updating existing regulations as well—including instituting an electronic Medical Device Reporting system, reforming regulatory initiatives, as well as defining its role in patient safety regulation.
“As we continue to look for ways to improve our ability to facilitate innovation and to speed safe and effective products to patients, we must not lose sight of the benefits of smart regulation, to the industry, patients, and society. Medical device regulation results in better, safer, more effective treatments and worldwide confidence in, and adoption of, the devices that industry produces,” Shuren said.
“I share your goal of smart, streamlined regulatory programs," Shuren told the chair and members of the subcommittee. "The Department’s plan for regulatory reform under President Obama’s Executive Order will heighten and maintain the focus on this important prinicipal.”
Shuren's testimony can be found here.