Among other reforms, Wyden would let outside reviewers approve low-risk devices, eliminate barriers that prohibit U.S. manufacturers from exporting devices that are approved for use in other countries but not yet approved here, and allow "breakthrough" drugs to be approved after one set of clinical trials, cutting approval times for those drugs by years rather than months. (Rumor has it that Wyden's newly found free market principles also coincide with his possible plans to challenge incumbent Republican Sen. Mark Hatfield next year.) Several trade-association representatives told me that, before the election, they would have been delighted to see the Wyden plan enacted. But they believe much more is now possible.
The most-sweeping FDA changes will probably come from the Medical Innovation Project, a collection of free market think tanks, academics, and trade associations assembled by the Progress & Freedom Foundation, a think tank that acts as House Speaker Newt Gingrich's brain trust. PFF Senior Fellow Tom Lenard, one of the project's leaders, argues that the FDA must eventually be replaced as a "politicized, risk-averse government-owned monopoly."
Lenard argues that developing public support for removing the agency's monopoly powers will take several years rather than a few months. "The public has to be assured that none of these changes will involve a dimunition of the standards under which drugs and devices are judged," he says. In July, the Medical Innovation Project plans to release a legislative agenda for private alternatives to many FDA functions.
In between the administration/Wyden proposals and those from the Medical Innovation Project are proposals the trade associations are coming up with themselves. Industry groups believe they can get substantive changes from this Congress, and they aren't willing to wait years for reforms to take effect. Yet there are striking differences over how far the different types of regulated firms will go. Brian Folkerts, a lobbyist for the National Food Processors Association, admits that "drugs and devices get most of the agency's attention, because the failure to approve them can lead to needless deaths." Even so, he says, the agency's "failure to act hurts our members' ability to provide healthy additives and ingredients." His group will prod the FDA to speed up approval of new items and push Congress to allow private groups to clear health claims made by food makers.
Pharmaceutical companies certainly have more regulatory hoops to jump through than food makers, so you might think they'd seek more thoroughgoing reforms. But they have benefited from the FDA's regulatory maze, which gives established drug companies a competitive advantage by erecting barriers to those firms that lack the expertise or patience to wait a dozen years to bring a new drug to market. "Successful drug companies can handle the approval process," one industry observer says. Drug firms would never advocate substantially loosening the FDA's bottleneck on approvals, the observer says, "because the current system lets [drug companies] earn near-monopoly profits."
PhRMA, the drug-makers' trade association, has indeed suggested ways to speed up drug approval--most notably by merging the separate FDA divisions that regulate drugs and biologics and requiring the agency to let independent reviewers gain FDA certification to conduct some drug-approval tests. But PhRMA would let the agency maintain its monopoly over approvals.
Device makers, by contrast, are less patient and much more
willing to get in the FDA's face. Before Congress passed the
Medical Device Amendments of 1976, the device industry hadn't been
regulated at all, and until the Safe Medical Devices Act passed in
1990, the FDA's Center for Devices and Radiological Health paid
scant attention to low- and medium-risk devices.
Before the 1990 device act passed, says Tommy Thompson, president of Quest Medical and chairman of the Medical Device Manufacturers Association (MDMA), the FDA could recall an unsafe device only after it was placed on the market; the new law forced device makers to submit their products for approval before selling them. "Although most changes in the SMDA didn't deal with product approval," says Thompson, "the FDA acted as if the SMDA dramatically expanded their authority."
Impatient device makers will attract a sympathetic hearing from congressional deregulators, including moderates and liberals, because they appeal to a motive everyone understands: self-interest. As many as 8,000 device manufacturers are scattered throughout the United States (and are thus located in many congressional districts); they employ 270,000 persons, comparable to the number who work in the semiconductor industry; and companies with fewer than 20 employees generate 64 percent of the industry's sales. As long as the preservation of "small businesses" and "high-tech" jobs remains politically sacrosanct, elected officials will scramble to mow down regulations that close down (or force overseas) cutting-edge companies in their districts.
It appears that the feisty two-and-a-half-year-old MDMA will get a more sympathetic hearing from Congress than the 700-member Health Industry Manufacturers Association (HIMA), which represents the industry's bigger, more-established firms. As trade associations are perceived, HIMA may be analogous to the U.S. Chamber of Commerce--solid corporate citizens who don't want to roil the political waters. MDMA is more like the National Federation of Independent Business, or even the Small Business Survival Committee--impatient and eager to mix it up with regulators if confrontation is needed to get products on the market. The 104th Congress, especially the pugnacious House, seems to revel in confrontation.
Both national associations agree on several reforms. They would eliminate controls that prohibit U.S. device makers from exporting devices that are approved in other countries but not here. They would allow all Class I, low-risk devices to reach the marketplace without the approval of the FDA, letting products such as toothpaste and contact lenses enter the market without first having to navigate the FDA bureaucracy. They would push Congress to develop a mission statement for the FDA and its device center, clarifying that the agency's purpose is to keep unsafe devices off the market while making new devices available as quickly as possible.
And along with the White House, HIMA and the MDMA want to eliminate the FDA's "Reference List." Under this internal policy, as described by several CEOs at the MDMA meeting in May, the agency often prevents a device company from getting approval for any of its new products if, in the past, the company has in any way violated manufacturing protocols. Once a device maker gets on the list, it tends to stay there, even after it resolves its problems and even if it develops completely different products. The administration promises that the agency will deny approval only to specific devices that don't meet agency standards, and not penalize those companies if they have other products in the pipeline.
Beyond these areas of consensus, HIMA and the MDMA take substantially different approaches on both the strategy and tactics of other FDA reforms. One contentious issue is "third party" approval of devices. Both groups oppose an administration plan that would impose "user fees" on companies that want to speed up the approval of new devices. HIMA would streamline the agency's device center, limiting its functions to reviewing devices and enforcing regulations; it would allow outside organizations to apply for FDA certification to review new devices. The MDMA, by contrast, would relocate the center as an independent part of the Public Health Service and completely privatize device approvals using independent outside reviewers.
In addition, both groups oppose the requirement that causes the biggest delay in device approvals: the FDA's demand that devices be regulated under the same "safety" and "effectiveness" standards as drugs. But the MDMA proposes changing the definition of "effectiveness" to encompass no more than truth in labeling. Under today's FDA standards, a device is considered to be "effective" only when, in the agency's judgment, it works as well as or better than other products on the market; the MDMA argues instead that a device is "effective" when it does what it says it will do. As long as devices are safe, the MDMA believes that doctors and patients, rather than the FDA, should decide which ones to use.
The MDMA spelled out its reforms in a 22-page blueprint published by the National Medical Device Coalition, an ad-hoc group of 10 national and regional device associations, representing large and small companies. The coalition shares one goal: to completely redesign the FDA's device center. The members include manufacturers of in-vitro diagnostics, dental implants, and contact lenses; the American Electronics Association; and the MDMA. Unlike HIMA, which hasn't reached far beyond its members to promote its reforms, the device coalition is actively approaching patient-advocacy groups and physicians associations to drum up grass-roots support for their legislative agenda.
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