Tired of the 510(k) Issue Yet? Capitol Hill Hearing Examinesthe Process

Like the annoying neighbor who continues to invite himself to backyard barbecues, the 510(k) issue keeps coming back. The process is flawed. No it isn’t. It’s too slow. No, it’s moving too quickly. Trying to keep up with the back and forth about the U.S. Food and Drug Administration (FDA) approval of new medical devices is enough to give you a sore neck.

During a recent hearing on Capitol Hill, lawmakers in the U.S. House of Representatives attempted to rein in some of the back and forth, hearing arguments from different sides of the debate examining the FDA’s regulation of the $150 billion U.S. medicaldevice industry.

Leaders at the FDA are in the process of overhauling the 510(k) system, which is used to clear most devices. On the one side are device manufacturers who charge that FDA reviews have gotten longer and less predictable, forcing some companies to launch their devices overseas to stay in business. They say American patients no longer have access to the latest medical treatments, while putting at risk American innovation in an industry it securely has led.

Consumer safety advocates say just the opposite. They claim the FDA is clearing too many devices, too quickly, jeopardizing patient safety.

The hearing on the impact of FDA device regulations on U.S. jobs was held at the health subcommittee of the Energy and Commerce Committee. The Energy and Commerce chairman, Fred Upton (R-Mich.), criticized the regulatory process.

“Device companies are being forced to market their devices first in Europe,” he said. “This hearing aims to fix that.”Republican lawmakers including Leonard Lance of New Jersey, home to many device makers, stressed the role of medical-device manufacturers in the U.S. economy, saying that delays in product approvals threaten U.S. pre-eminence in the industry.

According to the head of the FDA’s Center for Devices and Radiological Health, Jeffrey Shuren, M.D., the U.S. system is not inherently slower than Europe’s, though it does require an extra level of evidence. European regulators require that a device be safe and perform as described on its label. The FDA has those standards but also requires that the device be proven to successfully treat a disease or condition. Shuren points to a handful of devices that were rejected by the FDA and approved in Europe, only to later be recalled for safety reasons.

“There is significant underreporting of safety problems in some European countries, and it takes longer to identify safety problems in Europe,” Shuren said in written testimony.

The main problem the FDA has encountered in recent years, according to Shuren, is the declining quality of applications from device makers. Shuren claims that more than 50 percent of applications for conventional medical devices are missing key information, leading to delays that should have been avoided.

“We’re stepping up to the plate to do our part to get this right. But if it’s going to work we need industry to do their part,” Shuren told members of the subcommittee.

Also testifying were device industry entrepreneurs, who argued that the pace and unpredictability of FDA reviews is driving some companies into bankruptcy.

“Investment is drying up, companies are moving overseas or closing their doors and U.S. patients are being denied timely access to safe and effective new medical products,” said Josh Makower, M.D., a medical device inventor, a venture capital investor and consulting professor at Stanford University. Makower and the others pointed out that venture capital, which is critical to start-up companies, has dropped 37 percent across the device sector since 2007. While some of that decline is unquestionably due to the recession, entrepreneurs insist the FDA’s regulatory inconsistency also is to blame. Makower hammered home a key argument of device companies: that it typically takes companies two years longer to get devices approved in the U.S. than in Europe. That figure and others came from a survey sent to 750 device companies, in which only 17percent responded.

PricewaterhouseCoopers released a similar report last month and its conclusions relied on a survey of just 13 companies.

Mark Deem of the Foundry LLC, a group of device entrepreneurs and investors in California, said the FDA sometimes makes “impossible” demands for “extraordinary” data from companies, which has cost the United States jobs.

Patient safety advocates claim the opposite is true.

Steven Nissen, M.D., reiterated data from a study published this week suggesting the FDA is clearing too many devices through a fast-track pathway designed for low-risk devices. The analysis found that 70 percent of life-threatening recalls between 2005 and 2009 involved devices cleared through the speedier 510(k) method—which requires comparison to a predicate device already on the market, rather than a more rigorous system that relies on clinical trial data. Devices that go through a longer, more strenuous premarket approval process—or PMA—usually are novel devices that require extensive clinical testing and data over the course of years. Most 510(k) applications don’t require extensive clinical testing.

“There’s a serious problem here when 112 million devices were recalled in less than five years,” said Nissen, chairman of cardiovascular medicine at the Cleveland Clinic.

But the FDA has questioned the significance of the numbers, since the devices recalled represent about 1 percent of those approved via 510(k). Also, since the agency approves 90 percent of its devices through the fast-track program it’s expected that more of those devices would be recalled.

According to the industry’s largest trade group, the Advanced Medical Technology Association, or AdvaMed, more than 99 percent of devices cleared in the 510(k) program haven’t been recalled. The group warned that slowing down the program could harm patients.

Proposed Budget IncreasesFDA Funding

It is that time of year again. With Republicans in control of the House, Democrats in control (though by narrow margin) of the Senate and, of course, the White House, prepare for non-stop wrangling over the budget for the government’s 2012 fiscal year, which runs from Oct. 1 this year through Sept. 30.

As part of the budget request that was sent to Congress on Feb. 14, the Obama administration has requested $329 million in appropriations for the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH)—a 4.8 percent increase over current appropriation levels for CDRH.

For fiscal year 2012, the overall budget request for the FDA is $4.4 billion, a net program-level increase of $1 billion, or 33 percent, compared with FY 2010. The 2012 budget proposal includes increased investments to implement the FDA Food Safety Modernization Act, advance medical countermeasures, and improve drug and device safety. The release of the president’s proposed budget is the first step in the budget process as spending and revenue measures are considered by Congress.

FDA’s budget is included under the budget for the U.S. Department of Health and Human Services (HHS). Approximately 84 percent of the $892 billion in outlays for the FY 2012 budget proposal for HHS is allocated to entitlement programs, 54 percent for Medicare and 30 percent for Medicaid.

The proposed FY 2012 HHS budget also includes $32 billion for the National Institutes of Health (NIH), which represents an increase of $745 million compared with the FY 2010 enacted level, to support basic and clinical research. In FY 2012, NIH estimates that it will support a total of 36,852 research project grants, including 9158 new and competing awards. In FY 2012, NIH plans to establish the National Center for Advancing Translational Sciences (NCATS) as a mechanism for bridging the gap between basic science and therapeutic applications. With the creation of NCATS, the National Center for Research Resources will be abolished, and its programs will be transferred to the new center or other parts of NIH.

Dr. Margaret Hamburg, head of the FDA, defended her agency’s 33 percent funding hike, calling it “crucial to the modernization” of the agency, which regulates nearly 20 percent of all products purchased and consumed in the United States.

“The breadth of this mandate means that FDA responsibilities continue to grow. The new budget contains new resources so that FDA can fulfill its growing responsibilities to the American public,” Hamburg said in prepared remarks.

The final version of these numbers undoubtedly will change dramatically before the budget process is finished.

Obama Acknowledges Need forFDA Reform

During a recent presidential panel on jobs and competitiveness, President Obama said it was a goal of his administration to modernize the U.S. Food and Drug Administration (FDA).

The President said the agency is not prepared to handle emerging 21st century challenges in regulating food, drugs and devices.

“I’ve gotten a lot of commentary about the fact that … essentially their model was designed for the kind of medical devices you see in museums,” said Obama, according to The Financial Times.”So that would be an area where we should be getting a group to think strategically about how … [we design] these regulatory bodies so that they are up to speed and more responsive to a dynamic economy.”

The White House is continuing a push to reexamine and reform burdensome federal regulations in an effort to boost American job creation.

The administration isn’t just paying FDA reform lip service. In its fiscal year 2012 budget, the White House proposed a 33 percent increase in the FDA’s budget to $4.3 billion at a time when most agency budgets have been held steady to respond to concerns about budget deficits.