Last week’s U.S. House of Representatives Energy & Commerce Health Subcommittee hearing on the “Impact of Medical Device Regulation on Jobs and Patients,” provided FDA with an opportunity to defend itself, and it did.
Representing FDA was Jeffrey Shuren, director of the Center for Device and Radiological Health, who addressed the notion that Europe could be doing things better than the US, referring to FDA approval as the “gold standard” known throughout the world. Shuren’s remarks were partly in response to a recent study of 204 device companies that was supported by MDMA and the National Venture Capital Association, and co-authored by Josh Makower, a consulting professor of medicine with Stanford University and CEO of ExploraMed Development, and one of six industry experts who testified during the hearing.
Makower and Mark Deem, managing partner and chief technology partner of the business incubator, The Foundry, testified that current FDA practices were having an adverse effect on US medtech innovation and investment capital. Deem cited examples of start-ups that ceased to exist before gaining FDA approval due to costs and time involved, while Makower reiterated findings from his study showing FDA reviews for medical devices take on average two years longer than reviews for similar products in Europe, with no discernible benefit in patient safety or outcome, prompting some startups to introduce products offshore first.
Shuren pointed out, and rightfully so, that direct comparisons between the US and Europe are difficult because the EU relies on private companies for safety reviews while US law requires “devices be shown to be effective.” He went on to say that “Europe doesn’t have the accountability, consistency, and transparency [that the US does], making it almost impossible to compare it directly with Europe.”
But reality is reality and the FDA way of doing things is being compared with processes in other parts of the world, especially Europe. And to its credit, FDA is responding. On Feb 8, FDA announced its “Innovation Pathway,” a priority review program for “new, breakthrough medical devices” and announced that the first submission will be a “brain-controlled, upper-extremity prosthetic.” Earlier this year, FDA announced efforts to improve its 510(k) and Premarket Approval (PMA) programs.
“We recognize that we need to provide greater clarity [to device manufacturers] on what we need from them.” Later, Shuren added that delays are often drawn out due to “poor quality submissions and studies” because “companies are ignoring our recommendations. If we (industry and FDA) are going to fix this, FDA needs to make changes, but we need industry to be held responsible, too.”
Shuren’s assertion didn’t go unanswered. “We (device makers) are trying to help patents and sometimes the FDA requests and requirements are beyond what is reasonable and may be impossible in cases of early-stage technologies,” said Makower. “That disagreement is what is delaying innovation.”
Shuren also said that current FDA staffing is inadequate and that more funding and increased user fees are necessary. With proposed budget cuts on the table, Shuren said if the $272 million in CDRH funding is reduced, the previously announced Innovation Pathway effort would not be an option and other FDA efforts would be curtailed, causing further delays.
Also in support of greater funding was Steven E. Nissen, chair of the department of cardiovascular medicine with the Cleveland Clinic and Rita Redberg, director of women’s cardiovascular services, division of cardiology, with the UCSF Medical Center and editor of Archives of Internal Medicine. Redberg said the medical device market accounts for $135 billion in products, and yet CDRH receives a budget of only $272 million.
Medical Design commends the Congressional committee’s efforts and the panel members for their candor. Such exchanges must continue until it is clear to all involved that the US has the best system for ensuring the safety of medical devices and for fostering an environment for innovation. For more on the hearing, visit Perspectives at www.medicaldesign.com and click Blogs.