Medical Device Daily Washington Editor
WASHINGTON — The device and diagnostics industries are knee-deep in a number of issues, and the Advanced Medical Technology Association (AdvaMed; Washington) promises it will be in the mix again this year. One widely anticipated change at AdvaMed is the turnover at the position of chairman of the board, soon to be vacated by Michael Mussallem, CEO of Edwards Lifesciences (Irvine, California), whose replacement will be Jim Mazzo, president/CEO of Abbott Medical Optics (Santa Ana, California).
Mussallem and Steve Ubl, AdvaMed's president/CEO, offered no bombshells at their annual policy briefing Wednesday, but they did announce that the association is taking square aim at the device lag issue by commissioning a study by PricewaterhouseCoopers (PWC; New York) to evaluate the overall environment for device approvals in other nations compared to the U.S.
Ubl said, "The idea is to look at a set of elements" that influences device approvals, including intellectual property protection as well as the more obvious issue of regulatory review. "The interest is in stimulating a race to the top" of the device innovation heap among national governments, Ubl remarked. Mussallem observed that Japan arguably "has one of the slowest processes" in the developed world, noting that the term "device lag" is in common usage in reference to this market. PWC will file its first report in May.
In his opening remarks, Mussallem employed a bit of understatement when saying that his two years as the board chairman have been "an exciting two years," adding that "the priorities I had ... continue to be" priorities, including transparency at FDA. Mussallem foreshadowed the PWC study announcement with the remark that AdvaMed is "concerned when many of our innovations are in Europe first," making the case that "life sciences can have a tremendously positive impact on our economy."
Ubl seconded Mussallem's comments on the economic competition matter, noting that President Obama said in his State of the Union address that "second place isn't good enough" for any U.S. industry. Ubl continued, "life sciences is an area where we are in first place," a lead he said the U.S. would do well to sustain. Devices and diagnostics, considered jointly, are "one of the few industries that are a net exporter" for the U.S. economy, he said, but added, "We're on the bubble" of an import-export calculation resulting in a figure that is trending to "near zero."
Regarding FDA's intent to rewire the 510(k) process, Mussallem said, "We're very supportive of their efforts" at ensuring safety, but expressed an interest in seeing the agency "maintain a balance" between regulatory scrutiny and patient access. Payment reform also "gets a lot of conversation," he understated, acknowledging a preference that policymakers "mak[e] sure that quality ... and efficiency get rewarded" in a reimbursement scheme. Hence, while "the cost curve must be bent," patient choice is also an imperative.
As for congressional concern over the state of investment, Mussallem said Congress may believe that a heftier NIH budget suggests "that they've checked the box on innovation," which he argued requires "a much more complex" set of interactions. He reminded the media that venture capital has ebbed of late and that initial public offerings seem nearly extinct. "We're going to work to reauthorize the research and development tax credit," he said, and boost emphasis on the Small Business Innovation Research grants. Mussallem also acknowledged that "Senator Bayh will be sorely missed" where the R&D credit is concerned. This is in reference to Evan Bayh, the Indiana Democrat who recently announced he would not seek re-election to the Senate in November.
When asked whether absolute scientific certainty is the new standard at the Office of Device Evaluation at CDRH, Mussallem responded: "I think the short answer is no." He acknowledged that ODE "has a challenging job," adding that "there's not much of a human element" to pure science, which clearly is not characteristic of device applications.
"Everyone would love to have great science," Mussallem continued, but acquiring it "in a humane fashion is challenging" given the complexities of the safety/efficacy dynamic. Ubl added that device reviewers "do appreciate the balance that they need to strike," insisting that industry and FDA are "really on the same page" on the 510(k) process.
FDA eyes rule on trial data falsification
The clinical trial process has not generated as much controversy as the 510(k) process has – after all, few things have – but a few instances in which clinical trial data were treated casually or worse give FDA pause about the goings-on at clinical trial sites and institutional review boards. As a result, FDA is proposing to require that sponsors of clinical trials report any instances in which clinical trial data may have been falsified, intentionally or otherwise, within 45 days of becoming aware of the problem.
According to an announcement in the Feb. 19 edition of the Federal Register, the move is prompted by what FDA sees as "ambiguity in the current reporting scheme," although the agency does not expand on that remark in the announcement. The FR notice says that FDA "does not intend to impose any additional monitoring responsibilities" as a result, and instances of falsification can include anything that omits or adds data to such documentation "in such a way that the data do not represent what actually occurred."
The notice lists several types of falsifications, although sponsors "would not need to specifically categorize" any purported falsehoods when filing a report. Simple errors are not covered by the rule, however, and FDA says that it is "purposely not proposing to specify ... any particular information threshold that must be met" for the requirement to apply. However, FDA "invites comment on whether the regulation should specify some sort of evidentiary standard or minimum threshold for reporting."
Those who wish to comment have until May 20 to do so, the FR notice states, which also states that the requirement will go into force within 90 days of the announcement of the final rule.
Mark McCarty, 703-268-5690