While squabbles over the rules for approving new medical devices rarely attract much attention outside the insular world of manufacturers, regulators and medical professions, a fight is brewing that could have a major impact on efforts to control health-care spending.
The device industry has launched an aggressive campaign to avoid tighter Food and Drug Administration rules that would help generate the information needed to show whether newer devices are actually superior to the ones they replace. The latest devices – from heart valves and defibrillators to artificial knees and hips – are usually significantly more expensive than older devices, and the intense marketing surrounding the introduction of new devices has become a major driver of rising health care costs.
Many medical specialists say tighter rules are needed to ensure newer devices are safe and effective, which could help hold down costs. “Better regulation of medical devices has the potential to reduce health care costs,” said Steve Nissen, chairman of cardiovascular medicine at the Cleveland Clinic. “New devices are often more complex and expensive than existing products, but may not offer any improvements in health outcomes. The current regulatory approach allows these devices to reach the market with little or no clinical data.”
“Requiring evidence of benefit of effectiveness for patients before device approval would prevent billions of dollars from being spent on technologies that are not helpful for patients and are even harmful,” said Rita Redberg, editor of the Archives of Internal Medicine and a cardiologist at the University of California, San Francisco. “There are many examples, such as vertebroplasty and kyphoplasty for back pain [compression fractures], on which Medicare spends approximately $1 billion annually. After they were FDA-approved, randomized clinical trials showed they were no more effective than a sham procedure in relieving symptoms.”
Despite the cry for tighter rules, think tanks funded by industry in recent weeks have released several studies claiming that the FDA is standing in the way of improved devices getting to market. Congress is holding hearings to investigate the issue. And a third of the members of the House has signed a letter calling for legislation that would roll back a small excise tax that proponents claim is choking off “innovation.”
The 2.3 percent tax projected to generate $20 billion over the coming decade was part of the health-care-reform law and was similar to excise taxes slapped on the drug and insurance industries, which have not launched similar campaigns. All three industries are among the most profitable in America.
The controversy has important regional political significance because many of the device manufacturers are major employers in the Midwest – especially in Minnesota, Ohio, and Indiana. With the backing of Midwestern lawmakers, the industry is fighting back.
Rep. Erik Paulsen, R-Minn., whose district abuts the headquarters of industry giant Medtronic, last week released a letter with 154 co-signers, including four Democrats, that called for repealing the $2 billion-a-year tax. “Device manufacturers will have to cut R&D or may be forced to lay off employees due to this disastrous tax,” the letter said.
Proponents of the industry warn that what they describe as hostile government action could lead to a loss of jobs. Moreover, some manufacturers claim that they are looking overseas for a more permissive regulatory environment.
There are over 8,000 medical device companies in the U.S.; they generated about $136 billion in sales and employed over 422,000 last year, according to industry officials. While the industry did better than the economy as a whole through the recession, losing only 1.1 percent of its jobs compared with nearly 5 percent of all manufacturing workers, its job performance lagged behind the rest of the health-care economy, which added employment throughout the downturn.
Two years ago, the medical device industry, which manufactures everything from heart valves to ace bandages, came under tougher scrutiny. The FDA had become more aggressive overseeing the industry in response to criticism that it had repeatedly caved to corporate and political pressure when approving new products.
After health-care reformers targeted the industry for higher taxes to help pay for covering the uninsured, Democratic leaders in Congress asked the prestigious Institute of Medicine (IOM) to convene a blue-ribbon panel to determine if the industry needed tougher regulations to ensure the safety and effectiveness of its products. With the IOM’s final report due later this month, the industry is mounting a major public relations offensive to blunt calls for stronger oversight.
The Institute for Health Technology Studies, which is primarily funded by the industry, late last month released an industry survey showing American companies are increasingly going to Europe to get new devices approved. Industry executives also claimed that the FDA in the last few years has arbitrarily toughened its standards for new devices that are similar to products already on the market. In the past, those look-alike products usually received a less rigorous review than brand new medical innovations.
“As the FDA considers regulatory revisions, what’s at stake is the ability of companies to attract investors in order to continue developing innovative, life-saving products and sustaining American competitiveness in the global marketplace,” said John Linehan, a professor of biomedical engineering at Northwestern University and lead author of the survey.
Paulsen, the Minnesota lawmaker, cited the example of Xtent, a Menlo Park, Calif., device maker that tried to gain approval to start a U.S. clinical trial for its coronary stent. Surgeons had already inserted the company’s stent in hundreds of European patients. When the FDA refused to consider data from the European experiences and insisted on a prospective clinical trial, the company closed its doors and sold the technology to foreign investors.
Last week, the House Oversight and Government Reform Committee called in the FDA’s top device regulator to explain the changes underway at the agency, which Republican members claimed had gone too far. “In some cases, the conveyor belt for medical devices has come to a grinding halt,” charged Rep. Trey Gowdy, R-S.C., who chairs the health subcommittee.
Jeffrey Shuren, a lawyer and physician who 18 months ago replaced the previous head of the troubled Center for Devices and Radiological Health at FDA, promised to “do a far better job to make the process more efficient without compromising our standards for safety and efficacy.” Earlier this year, the FDA proposed new rules that would give companies more certainty about what would be expected from them when bringing new products to the agency. But it postponed consideration of any major changes in the oversight process pending the IOM report, which could propose companies do more clinical trials proving efficacy for follow-on devices.
The current rules are a product of the 1976 law that ushered in the modern era of medical device regulation. They require any new device whose failure would pose a serious risk to public health to go through rigorous clinical trial testing in humans for both safety and effectiveness before going on the market.
But the law also set up a regulatory scheme, known as the 510(k) process, which allows follow-on devices deemed substantially similar to something already on the market to get approved without the same level of testing. Regulators have discretionary power to order more tests.
The vast majority of new devices use the follow-on process, even though their manufacturers often claim superior performance to the older models and charge accordingly. The result is a lack of scientific data for making those comparisons, which leaves Medicare, private insurers and physicians in the dark as to their relative worth.
The regulatory framework for potentially life-saving devices differs from drugs, where follow-on products – say, the four or fifth statin to come to market for lowering cholesterol – must still go through rigorous clinical trial testing. While that doesn’t meet the gold standard of head-to-head comparisons between competing products, at least that gives medical analysts sufficient information to know if one drug is significantly better or worse than another product in the same class.
Safety issues can arise when there are no clinical trials for follow-on devices. And that also contributes to rising health care spending, since it can result in costly recalls or even follow-on operations to replace faulty devices.
The updated devices often change materials or tweak the engineering, which can alter their performance once put in the body or deployed in health care settings. A study published earlier this year in Archives of Internal Medicine found that of 113 major product recalls between 2005 and 2009, only 19 percent had gone through the more rigorous clinical trial testing required for new products, while 71 percent had used the follow-on process. There had been only 49 major recalls in the prior five years.
“Yes, the FDA’s getting tougher and it’s long overdue,” said the study’s lead author, Diana Zuckerman, executive director of the National Research Center for Women and Families. “Too many things were sailing through without clear evidence they were safe and effective.” She cited last December’s recall of 359 million glucose test strips manufactured by Abbott Laboratories, whose malfunction could give diabetics false readings and lead to under or over-medication.
Last week Redberg of UCSF told the Oversight subcommittee to reject calls for speeding up the regulatory review process in the name of fostering greater innovation. She cited a 2009 Government Accountability Office report that found that a majority of high-risk devices do not go through clinical trial testing prior to marketing. “Only high-quality clinical trials can assure safety and effectiveness, especially when it comes to high risk devices that are used with invasive procedures,” she said.