Medical Device Daily Washington Editor
WASHINGTON – Dan Schultz, MD, director of the Center for Devices and Radiological Health at FDA, gave a brief address at this year's annual meeting of the Medical Device Manufacturers Association (MDMA; Washington), and had a lot to say about a lot of things.
One of the things he said is that with all the criticism of the 510(k) program at CDRH, more devices could end up as de novo 510(k)s if only because it is one of the center's regulatory options that are not used "to their maximum effect."
Schultz opened his remarks Tuesday by observing, "I get told a lot that the goalposts are moving" at FDA. "Of course the goalposts are moving," he said, and "there are a lot of reasons" for this, including the fact that technology is changing. "That's your fault," he told the audience, but added that as a physician, "I appreciate that."
All the same, "public expectations continue to evolve" with regard to safety, Schultz remarked, so even though "because of the technology you make, the operating room is a safer place," expectations are higher still. "The sense is that we're somewhat victims of our own success," he said, adding that rates of adverse events "that would have been acceptable and even laudable even 10 years ago" are now scarcely acceptable. "I think we need to explain risk and benefit in a way that I think we haven't done in the past," he stated.
The discussion of de novo 510(k)s came at the end of Schultz's remarks, and his initial response to a question about whether more devices would end up as de novos was "I'm not sure I would frame it as lowering the threshold" to bring more devices into the de novo part of the 510(k) program. "Everyone in this room understands that a 510(k) is not the mindless rubber stamp" that it is often perceived to be, a message he said FDA will try to convey, although he cautioned that such an effort is not necessarily going to work.
As for the technological drift induced by the continuous build-on of predicate devices, Schultz said "we need to do a better job of defining that path and making it much clearer how those decisions were made along the way. There are a lot of people who don't trust the system and we need to build that trust back up," he said.
Schultz said the agency is keenly aware that device firms are more and more commonly multi-national entities, remarking, "Clearly, the regulatory system was not designed for a global marketplace." This subject touches on the intent of the Food and Drug Administration Globalization Act of 2009, which would put FDA in the position of conducting more overseas inspections for makers of drugs, devices and food products (Medical Device Daily, Jan. 30, 2009). "It doesn't matter where the finished device is made if the components are made all over the place," Schultz said.
"If there's a word you're going to be hearing more of in the next four years, it's going to be 'transparency,'" he said, a message he said seems to be coming from "on high" rather than just from within FDA.
Earlier in the day, FDA had announced the opening of the FDA Transparency Blog and the formation of the FDA Transparency Task Force, which will meet June 24 to begin work on processes designed to make the agency's operations more open. In a June 2 statement on the blog, Secretary of Health and Human Services Kathleen Sebelius said, "our administration is committed to eliminating the barriers between the American people and their government, and the Task Force is another big step in the right direction." Deputy FDA commissioner Joshua Sharfstein will chair the task force.
"Reliance on interactive review, I think, is reborn," Schultz, acknowledging that the agency and industry "got off track" on the idea. Greater participation in interactive review would allow FDA to "reserve the [deficiency] letter for the larger issues" that cannot be dealt with over the phone. "When we have interactive review, we do a better job" and devices that should go to market get there more expeditiously.
The unique device identifier "is something that is clearly coming," Schultz advised the audience, adding that the electronic medical device report (e-MDR) is also looming on the horizon. "I would strongly encourage you to give this some consideration."
Following Schultz's talk, a panel took the dais to review recent developments on Capitol Hill. Leading off the session was John Manthei, a partner at Latham and Watkins (Washington), who said the Senate will soon vote on "the biggest series of reforms at FDA" in decades. "I can't think of a more contentious, controversial" change than putting tobacco into FDA's portfolio, he said.
The reference is to the Family Smoking Prevention and Tobacco Control Act of 2009, which the House passed earlier this year by 298-112, while the Senate Health, Education, Labor and Pensions Committee forwarded the upper chamber's version to the full Senate in April (MDD, April 28, 2009).
"It's a new day in Washington," Manthei said, echoing comments he made about the traditional five-year legislative hits absorbed by FDA at the FDA/FDLI annual conference earlier this year (MDD, April 27, 2009). "Those days are over, and industry has to brace itself" for annual updates to legislation affecting the agency and, by extension, industry.
Manthei noted that Congress is likely to undertake an "evaluation of the 510(k) program," adding that the program "may be materially reformed." He suggested that industry defend the process. He also said more enforcement activity can be expected, and noted that the approaches of inspections of device manufacturers' facilities will have to be reconciled and which is "another area in which it's important that industry is heard."
Later in the discussion, Manthei and Nick Shipley, director of government relations at the healthcare consultancy the McManus Group (Washington) and formerly a Democratic staffer, said the 510(k) program is of intense interest in the House Energy and Commerce Committee and would fall under the committee's health subcommittee, which is chaired by Rep. Frank Pallone (D-New Jersey). However, Pallone's involvement in the Menaflex 510(k) by ReGen Biologics (Franklin Lakes, New Jersey) could make any such moves ticklish for Pallone, and he recently told Medical Device Daily that he could not be sure when hearings on the 510(k) program might move onto the top of the subcommittee's list (MDD, May 14, 2009).
MDD asked Manthei and Shipley whether such an investigation might be handled by the Oversight and Investigations Subcommittee, chaired by Rep. Bart Stupak (D-Michigan). Shipley said "there is definitely an opportunity for Stupak to step up and take over" the 510(k) question, while Manthei said, "if I had to handicap it, I would put it in Stupak's committee."