The president of the Society for Cardiovascular Angiography and founder of the Children with Diabetes Foundation made the case for faster medical device approvals at a July 17 AdvaMed meeting at Washington DC’s National Press Club.
Jeff Hitchcock, founder of the diabetes foundation, pointed to promising study results of a recent trial of the artificial bionic pancreas, which resulted in 37% fewer interventions for low blood glucose, but lamented that patients weren’t able to keep the device, saying, “The [research] team never anticipated the horror of the patients of having to give it back.”
“They had lived for five days without diabetes, without worrying about what they ate, never having to count carbohydrates, never going low at night. And they had to turn it back in. For our community we look forward to rapid advancement, clinical trials and approvals by FDA for these advanced technologies.”
Meanwhile, cardiologist and president of SCAI Jim Blankenship issued a reminder that “we are consistently about two generations behind Europe in terms of the kinds of devices that we can use for our heart patients,” and did not predict improvement in this arena.
The speakers agreed that asymmetric incentives at the FDA explain why bioresorbable stents and a host of other devices are available in Europe, and sometimes emerging markets as well, but not the U.S. “In a sense, I can’t blame the FDA [for being risk averse] because any time we approve something that turns out to not be as good as we initially thought or even has deleterious effects, they get raked over the coal,” said Blankenship.
|Ross DeVol, chief research officer at the Milken Institute|
Hitchcock concurred, saying, “FDA gets in trouble if they approve a device that doesn’t work quite as well, but they are never called to task for the patients who died or had bad outcomes while they delay their approvals, and perhaps we need to remind them that their inaction has very serious consequences.” As Ross DeVol, chief research officer at the Milken Institute, put it, “I think the other thing we have to recognize is that there are incentives, or a lack of incentives, at the FDA itself.”
The speakers also said the medical device tax and high corporate tax rates are deterring innovation. And Rep. Fred Upton (R-MI), who chairs the 21st Century Cures Initiative, told AvdaMed president Stephen J. Ubl that tax reform is on the way.
“Pfizer’s the largest employer [in my district], and as you all know they almost had a deal with AstraZeneca in large part because of the tax structure,” he said, referring to inversion. “We’ve got to lower the [35% corporate] rate as well. I’m encouraged that that’s going to happen. We’ve got to get this done.
“Early next year we’ll be ready to move a bill that should have strong bipartisan support, certainly in the house.”
The hearing was held to discuss an AdvaMed-funded study conducted by the Milken Institute, which found that the economy experienced a net annual benefit of $23.6 billion from the use of medical technologies to address four health conditions: diabetes, heart disease, musculoskeletal disease and colorectal cancer.