The medical device industry’s public relations campaign to push the regulatory agenda its way hit another level today, with industry advocates testifying before a U.S. House subcommittee, studies taking aim at the Food & Drug Administration and even an op-ed from a pair of friendly legislators.
A House Energy and Commerce panel, the subcommittee on health, is slated to hear about the “Impact of Medical Device Regulation on Jobs and Patients” today, led by chairman Rep. Joe Pitts (R-Pa.). Med-tech industry reps will likely find a sympathetic ear in Pitts.
Pivoting off of a trio of recent studies by PricewaterhouseCoopers, Stanford University and the Boston Consulting Group which conclude that medical innovation in the U.S. is sagging from over-regulation, Pitts authored an op-ed column this week signaling his intention to “explore why Europe has gained such a significant advantage over American companies.”
“Unfortunately, the FDA has become risk-averse in recent years,” he wrote.”Approval times have crept up, nearly doubling the time required in some cases. This means that European patients are receiving access to devices two years before American patients. In some cases, devices approved in Europe have never been legal in the U.S.”
Pitts, a member of Energy & Commerce’s health panel since 2001, is no stranger to the medical device industry — he sponsored the Medical Device User Fee Stabilization Act of 2005, which eliminated a trigger in the original 2002 user fee act that would have terminated the program. His website hails the bill’s passage as saving “an important program at the Food & Drug Administration that helped manufacturers of life-saving devices avoid lengthy approval delays.” Pitts was also one of 12 congressmen that sent a letter to FDA head Dr. Margaret Hamburg asking the agency for more transparency as it mulls changes to its 510(k) medical device clearance program.
Slated to testify before the Pitts panel is Ralph Hall, a University of Minnesota Law School professor with strong ties to the device sector. Hall, who specializes in FDA law and compliance, also represents device makers on FDA matters and is CEO of MR3 Medical LLC, which he calls “a four-person start-up medical device company working on a new technology for cardiac rhythm devices.” He’s called for more data on the FDA’s 510(k) protocol before widespread changes planned by the Obama Administration go into effect, saying he’s concerned that “we are doing a ‘ready, fire, aim.'”
“My concern is We don’t understand if there are substantive problems,” Hall told an FDA official last year at a “town hall” meeting in Minneapolis.
In testimony prepared for today’s subcommittee hearing, Hall detailed the results of a study he conducted on “the overall safety profile of medical devices approved or cleared by FDA” from 2005 to 2009. Using Class I safety recall data — denoting the FDA’s most serious recall level — Hall found that the 510(k) program has “an excellent safety profile,” with only half a percent of clearances during the study period resulting in a Class I recall and less than 0.3 percent resulting in a Class I recall “recall for any reason relevant to the 510(k) pre-market system.”
“It must be remembered that all devices carry risk and that Congress has balanced patient access to new technology with pre-market processes by creating the standard that there must be ‘reasonable assurance’ of product safety before the product should be marketed,” Hall wrote.
“The 510(k) clearance program has a track record of protecting public health,” added Dave Fisher, executive director of the Medical Imaging & Technology Alliance, in prepared remarks. “As manufacturers innovate diagnostic technologies, it’s important that the clearance process improve so that it can continue to spur innovation and create jobs.”
Another report, released today by the California Healthcare Institute and the Boston Consulting Group, takes aim at the pace of clearances and approvals at the federal watchdog agency. The authors found that 510(k) clearances have slowed by 43 percent compared with the average for 2003 through 2007, with PMA approvals lengthening 75 percent and drugs and biologics approval times rising 28 percent
“Patients here in the U.S. ultimately suffer when there are delays in bringing new medical discoveries to the market,” CHI president and CEO David Gollaher said in prepared remarks. “With foreign regulatory agencies, such as the European Medicines Agency, focused on enhancing the competitiveness of their industry as well as the safety of new drugs and devices, inefficiency at the FDA has resulted in American inventions being made available to patients and physicians in other countries first.”
Back inside the Beltway, Pitts is not the only device-friendly legislator on Capital Hill, nor the least reticent on the subject. Writing today in the Washington Times, Sens. Richard Burr (R-N.C.) and Dr. Tom Coburn (R-Okla.) said some of the FDA’s actions “are eroding America’s leadership in medical innovation.”
“We need an FDA that embraces a culture that places more primacy on the promotion of patient benefit than the status quo. FDA reviewers need to weigh potential dangers from innovative treatments against the potential life-improving benefits to patients. Too many promising treatments are languishing behind mounting rules that cannot be justified by a focus on safety alone,” Burr and Coburn wrote. “The FDA‘s regulatory malaise harms innovators, too. Today, device companies are launching products in Europe years before they approach the U.S. market. The New York Times recently highlighted the story of a California woman who had to travel to Europe to have a specific spinal device that was manufactured just 40 miles from her home. She could not get the device in the United States because the FDA was still reviewing the product.”