Medical Device Daily Washington Editor

WASHINGTON — The 510(k) program has been under fire for some time, and yesterday's hearing in the health subcommittee for the House Energy and Commerce Committee confirmed that Congress is keenly aware of at least the reports of problems that surface on a seemingly routine basis.

Adding fuel to the anti-device industry fire are events such as the indictment of officials at Synthes North America (West Chester, Pennsylvania) (Medical Device Daily, June 18, 2009), although such illicit behavior was not the focus of yesterday's hearing. However, while the hearing was canceled before the committee could query the witnesses about device approvals, there was no indication that Congress anticipates any statutory change to the 510(k) and PMA programs.

Subcommittee Chairman Frank Pallone (D-New Jersey), who was involved in the intervention on behalf of Regen Biologics (Franklin Lakes, New Jersey) in connection with the company's Menaflex application, opened by stating that the purpose of the hearing was "to determine if the current regulations are doing enough for patients," adding that he sees "evidence of an approval system that is broken."

Pallone acknowledged that thanks to medical technology, "many illnesses that were once a death sentence are now curable or at least manageable," but asserted "we need an approval process that keeps pace with technology." He also said that his greatest interest is "to find out what FDA needs to ensure that the medical devices that are on the market are safe and effective." However, Pallone did not directly address the agency's funding.

Rep. Michael Burgess (R-Texas), said, "it is my firm opinion that this meeting should be about science and solutions," and questioned why nobody from FDA was on the witness panel. "As often as I complain about how often" FDAers are brought up to the Hill for hearings, he expressed doubts about the constitution of the panel "when it is clear that resources are the real remedy."

"I think we need to hear from the commissioner of FDA ... to hear what they need," Burgess said, adding that he sees "a troubling trend in our conversations" about drugs and devices in that FDA was not present at a recent hearing about biosimilars.

Marcia Cross, director of healthcare at the Government Accountability Office, said that GAO "added FDA's oversight of medical products, including medical devices, to its list of high-risk areas warranting attention by Congress and the executive branch." She also noted that the agency was inspecting domestic firms making high-risk devices every three years despite a statutory requirement of biennial inspections.

"There is no comparable requirement to inspect foreign establishments," Cross said, with foreign establishments making high-risk devices facing inspections no more frequently than every three years. She also reminded the committee that the FDA Science Board had "found that FDA's resources had not increased in proportion to the growing demands placed" on the agency.

"The agency's ability to understand the risk of adverse events related to the use of medical devices ... is limited by both a lack of informative, validated adverse events reports and by a lack of quality epidemiological information," Cross said. She also noted that FDA's system is a passive system and that "the volume of reports exceed the center's ability to consistently enter or review the data in a routine manner."

William Maisel, MD, a cardiologist and the director of the Medical Device Safety Institute (Boston), made note of several recent device safety issues and the recent controversies regarding device approvals sparked by public letters from reviewers at CDRH. "FDA device scientists have alleged wrongdoing," but "these allegations divert attention from the tireless efforts" by many FDA personnel "to ensure that only safe and effective medical devices reach the American public."

Maisel said, "unnecessarily slowing the device approval process is akin to leaving patients with an outdated, antique telephone in an iPhone world," but also that "it is critical that the safety and performance of medical devices be improved."

Maisel reminded the panel that the Sprint Fidelis lead, made by Medtronic (Minneapolis), was approved as a PMA supplement "with no human clinical data," adding that a number of other such clearances have gone out.

"Only by demanding more thorough medical device evaluations can FDA hope to reestablish consumer confidence in its ability to protect the public's health."