WASHINGTON — When Jeffrey Shuren, MD, director of FDA’s Center for Devices and Radiological Health (CDRH) addressed a conference of small device companies recently, he assured them, “We get it.”
But the audience was not convinced.
Of late, device makers have become increasingly vocal about problems with the FDA approval process, claiming long delays, and little consistency in FDA decisions.
For example, a recent survey of device makers found most think the FDA is unpredictable, and many seek approval for new products in Europe before coming to U.S. regulators.
One small device company was so frustrated by what it characterized as FDA foot-dragging and vacillating on the company’s study design that it filed a Citizen Petition with the agency demanding answers from FDA Commissioner Margaret Hamburg, MD, within 180 days.
A More “Adversarial” Environment
Shuren, speaking at a conference of the Medical Device Manufacturers Association (MDMA) said he was aware of the more adversarial relationship between FDA and device makers, which he said included “a lot of finger-pointing.”
When pressed on what, exactly, has become more “adversarial,” about the relationship between medical device companies and the agency that regulates them, Shuren declined to mention specifics.
But industry representatives said they feel the tension.
“I think patients are always better served when industry and FDA work together, “said Mark Leahey, President and CEO of MDMA, which bills itself as the “voice for smaller” medical technology companies. “I think, unfortunately, there have been instances in the past couple years where FDA is being more confrontational with industry than collaborative.”
David Nexon, senior executive vice president of AdvaMed, the largest medical device lobbying group, stopped short of characterizing the current relationship between industry and the agency that regulates it as adversarial, but he admitted device groups are increasingly agitated with the FDA.
“We really feel we want to be a partner with the FDA, we really want to produce improved treatments and cures,” said Nexon. “At the same time, people are very frustrated with FDA’s performance.”
The “performance” Nexon references appears to be the most common complaint in the device industry: approval decisions take too long, and the review process has too many bumps along the way.
Much of the recent criticism of the FDA was aimed at the agency’s fast-track 510(k) approval process for devices, which is the process used for 90% of the devices considered by the agency.
The finger-pointing noted by Shuren was especially rampant at a recentcongressional hearing called “FDA Medical Device Approval: Is there a Better Way?” during which Republican members of Congress voiced the concerns of device companies. In Congress, the practice of seeking approval outside the U.S. before approaching the FDA is considered a worrisome sign.
Shuren was the star witness at that hearing, and he defended FDA’s process. The agency was not perfect, he said, but it shouldn’t look to the European system as a guide. He explained Europe chooses to overlook efficacy and instead requires device companies to only prove their devices are safe.
“If we have good technologies that are safe and effective, we want to get them to patients,” Shuren told the healthcare subcommittee of the House Committee on Oversight and Government Reform during a June 3 hearing. “We don’t do our healthcare system justice if we’re getting out devices that aren’t effective.”
The week before that hearing, Shuren defended the agency after a new report from Northwestern University that found device companies are frustrated by the unpredictable nature of the FDA’s fast-track 510(k) approval process.
The study was funded by the Institute for Health Technology Studies, a nonprofit group that is funded by medical device companies and the Advanced Medical Technology Association.
Diana Zuckerman, PhD, president of the National Research Center for Women and Families keeps a very close eye on FDA approvals and is a common presence at FDA and congressional hearings. She, too, said she noticed a more adversarial tone at hearings.
She was a witness in a recent Senate Special Committee on Aging hearing, during which the Government Accountability Office (GAO) released a report criticizing the way in which recalls of devices approved through the 510(k) process are handled.
At that hearing, it was particularly clear that there are those who feel FDA’s fast-track process doesn’t do enough to guarantee patient safety. By speeding up approval, the FDA runs the risk of approving dangerous devices, witnesses told the committee.
One example of a fast track approval that ran into safety problems is the DePuy ASR prosthetic hip. That hip replacement device was approved in 2006 through the 510(k) process but recalled in 2010 after it was found to malfunction at a much higher rate than expected.
But there are also those who say the FDA’s fast-track approval process is a very safe route for devices to come to the market. According to figures from the Institute of Medicine (IOM), only 1.5% of all devices approved through the 510(k) process are recalled.
Zuckerman (who authored a study with Cleveland Clinic cardiologist Steve Nissen, MD, that called into question those IOM numbers) told MedPage Today that the FDA’s device-approval standards have improved, but they still aren’t good enough.
“As a nonprofit organization that pays a lot of attention to medical devices, we have noticed — it would be hard to miss — that the FDA [has begun] … holding devices to standards that are slightly more rigorous,” she said, adding that the standard is still “much less rigorous than the requirements for prescription drugs.”
Longer Wait Times Irk Device Companies
Premarket approvals take 28% longer now than they did during the 2003-2007 time period, and 510(k) approvals have slowed by 43%, according to a study by the California Health Institute, an organization that advocates for California’s device industry.
The average time from submission to FDA approval for devices is a little less than five months in Europe, and about 13 months in the U.S., the Northwestern study found.
Shuren told the congressional panel that the agency is pretty much hitting its marks for approval times.
For instance, under the 510(k) program, which is used for nine out of 10 devices examined by the agency, 90% of the agency’s reviews are completed in 90 days or less, and 98% of reviews were completed in 150 days or less. But that was just for the devices whose makers pay a tax to the FDA (which was mandated by the Medical Device User Fee and Modernization Act — or MDUFMA for short).
Shuren told the panel the average time for all 510(k) submissions stands at about 140 days.
Nexon of AdvaMed said the FDA is meeting its own time goals, but overall time for approval is growing.
“FDA recognizes that it can do a better job at managing its premarket review programs,” Shuren said.
Part of the problem is the case load, Shuren said. CDER’s workload has increased by 26% since 2007, driven by a significant increase in requests from device makers, Shuren said.
Nexon said it has become increasingly difficult to get a meeting at the FDA, which many companies see as one of the most important first steps toward device approval.
Device companies also criticize the FDA’s reviewers, and Shuren will admit that the reviewers need better training. Device companies have complained that reviewers will tell them one thing, and then come back asking for something totally different.
In the Northwestern University survey, more than half of respondents said it’s “somewhat unclear or uncertain” what the FDA wants in terms of preparing for a 510(k) submission, and 72% said there is a difference between what guidance documents say and what FDA reviewers say during the review process.
Nearly half of the reviewers in the CDRH have four years or less of reviewing experience, and the majority of the front line supervisors have three years or less, Shuren said.
Shuren recently announced that every new reviewer at the agency will have to undergo training, rather than cutting their teeth on a device application, which was the old approach.
Shuren would like to hire more experienced reviewers, preferably physicians who have a better understanding of the human body and how medical devices work, but hiring doctors is very expensive, he said, particularly when the agency is competing with device companies, some of which can afford to pay physician reviewers a hefty salary.
He said it’s difficult to compete with the private sector when the FDA is very limited in what it can pay its reviewers.
While FDA appropriations have increased in recent years, the money was for other areas of the agency and device pre-market approval operations didn’t see that money, Shuren said.
The drug approval operation at FDA is much more well-funded because it collects about 10 times more in user fees from pharmaceutical companies.
When asked if increasing user fees on device companies might help pay for better trained reviewers and speed up the process of device approvals, Janet Trunzo, executive vice president of technology and regulatory affairs at AdvaMed, said the company couldn’t discuss user fees because it is in the midst of negotiations on MDUFMA, which is up for reauthorization in 2012.
That reauthorization is also a likely contributor to the tension between industry and FDA.
Money aside, reviewers get burned out at the FDA, because of a very high workload and the increased criticism of the department, Shuren said.
“Just being beaten on is draining,” he told reporters.
Shuren consistently talks about the changes that are coming in device approval, including better trained reviewers, more guidance documents, and better communication with companies. He recently announced 25 changes the FDA would make to its device approval process. But the agency is holding off on big changes until the Institute of Medicine issues a report on device approvals this summer.
Too Cozy With Industry
It’s no secret that many at the FDA leave the agency, opting for the heftier paychecks that come along with working in the private sector. And that has raised some eyebrows.
For instance, former FDA Commissioner Andrew von Eschenbach, Dan Schultz, the former head of CDRH, and Heather Rosecrans, the former director of the FDA’s 510(k) program all work for Washington-based Greenleaf Health, a firm that consults for device companies.
“Almost everyone who headed up CDRH left to work for device companies,” Zuckerman said. “It’s not surprising that it feels more adversarial, because it was so cozy before.”
Zuckerman said companies are complaining about how long the FDA is taking “compared to the good old days.” She said the FDA during the Bush administration had a “lack of rigor” in approving devices.
But Nexon dismissed allegations that industry was happier with the device approval climate during the previous administration.
“That doesn’t ring true to us,” Nexon said. “The decline in FDA performance began in 2007, and it’s continuing to decline under this administration. It’s not really a partisan issue.”