The agency is more concerned with managing its image than solving its problems.
FDA’s leadership appeared to have an inkling about the Institute of Medicine’s (IOM) recommendation to scrap the 510(k) program weeks before its controversial report became public.
Don’t expect we’ll buy it, FDA seemed to be saying. It will be only a recommendation.
How was FDA able to make that play ahead of time? My bet is a high-level leak gave FDA and the industry’s main lobbying group, AdvaMed, a chance to get their collective ducks in a row and swamp the first wave of media accounts with a common, negative position: namely, that junking the 510(k) is a bad idea. The insular nature of this apparent closed circuit suggests a new political reality for FDA and its numerous constituencies, one that emphasizes the importance of stage-managing troublesome controversies as they emerge.
The day before the report came out, FDA commissioner Margaret Hamburg repeated the “only recommendations” party line while addressing the Senate Committee of Health, Education, Labor, and Pensions. Hamburg said she was aware of industry concerns about the IOM committee’s lack of industry representatives. A month before she spoke, the industry-funded Washington Legal Foundation petitioned the agency to disregard any advice it received from the IOM committee for precisely that reason, arguing that the committee did not meet the fair balance requirements of the Federal Advisory Committee Act of 1972.
Virtually instantaneous post-release comments—unprecedented, in my experience—from CDRH director Jeffrey Shuren and AdvaMed defended the 510(k) program against the report. The IOM’s criticisms centered on the regulatory pathway’s failure to provide assurance of safety and effectiveness. The committee concluded that the 510(k) program can’t be fixed and should be replaced.
In reaching this astonishing position, the committee basically rewrote the 510(k) statute by defining safety and effectiveness as risk management. In the process, it drove industry and its regulatory agency closer together and helped push the debate into the political maelstrom of Washington.
The impact of the recommendation, which hits the reader like a two-by-four between the eyes, is not the most striking thing about the 249-page report. That would be its conversion of the original 510(k) concept into a mundane, intricate risk-management program, like something one would see in the pharmaceutical industry. This is something that the 510(k) statute’s authors, who saw the program as a stroke of genius when they wrote it in 1976, never contemplated.
“The most important development after 1976,” the IOM report reads, “was the evolution of the 510(k) clearance process from a transitional tool for preclearance of postamendment devices to a permanent and dominant means of premarket review for most postamendment devices.”
Attorney Larry Pilot, who, in addition to helping write the Medical Device Amendments to the Food, Drug, and Cosmetic Act in 1976, helped FDA implement them as director of medical device compliance, is among those criticizing the IOM’s report. From its opening page, Pilot told me, the report mischaracterizes the purpose of the three classes of medical device established by the 1976 amendments.
According to the report, the MDA “created three classes of device types on the basis of the risks posed and the ability of postmarket controls to manage them.” The report then claims that “as originally contemplated,” the devices were to be grouped according to risk level, with “high-risk” devices in Class III, “moderate-risk” devices in Class II, and “low-risk” devices in Class I.
That’s just plain wrong, Pilot says. Sec. 513 of the Food, Drug, and Cosmetic Act, which governs the classification of medical devices, does not use the terms “high risk,” “moderate risk,” or “low risk” at all. The word "risk" only appears twice in the section: once in the description of Class I devices (which are defined as those that do "not present a potential unreasonable risk of illness or injury..."), and again in the description of Class III devices (which are defined as those that present "a potential unreasonable risk of illness or injury..."). Thus, Pilot says, the IOM report is wrong to claim that the 510(k) program was devised as a risk-management mechanism. Indeed, the 510(k) section itself does not mention the word “risk” or even “safety and effectiveness.”
Rather academically, the report attempts to measure FDA’s 510(k) program against the “ideal” medical device regulatory system, an artifact it created for the purpose of argument. The ideal system, the report reads, must be risk-based, grounded in sound science, and “clear, predictable, straightforward, and fair.” The system should also be self-sustaining and self-improving, support innovation that improves public health, and ensure safety and effectiveness via the appropriate and relevant authorities.
Because the 510(k) statute says nothing about risk management or safety and effectiveness, the authors of the IOM report scorn its “substantial equivalence” standard. This allows a new device to be deemed substantially equivalent to a device that was on the market before 1976, enabling it to be approved via the 510(k) pathway.
“According to the FDA and the Supreme Court,” the report reads, “when the FDA finds a device substantially equivalent to a predicate device, it has done no more than find that the new device is as safe and effective as the predicate.” This is not enough, the report continues, because the “devices that were on the market before the enactment of the 1976 MDA — the origin of all predicate devices for the 510(k) process — have never been systematically assessed to determine their safety and effectiveness.”
Unsurprisingly, the report also finds fault with industry’s practice of citing a new device’s “substantial equivalence” to multiple predicates in order to stretch the pedigree of that device back to a device made before 1976.
The industry and FDA din over the IOM’s report seemed to carry the day until a New England Journal of Medicine article emerged to sing the report’s praises. The piece, titled “Medical Devices—Balancing Regulation and Innovation,” was written by Gregory Curfman, executive editor of NEJM, and Rita Redberg, the editor of the Archives of Internal Medicine.
Curfman and Redberg called the use of predicates to evaluate safety and effectiveness “untenable,” part of a system conceived “in an era of much simpler and fewer devices.” The authors cited the withdrawal of DePuy’s ASR XL Acetabular System metal-on-metal hip after nearly 100,000 implants and five years on the market. The 510(k)-cleared Class III device was found to shed minute particles of metal into patients’ tissues and blood streams, and, the authors write, it became a “public health nightmare.”
The authors mention Rep. Cliff Stearns’ (R-FL) argument that FDA regulations are an undue obstacle to industry. In countering this commonly echoed sentiment, Curfman and Redberg cite the DePuy hip case, claiming that it demonstrates the danger of “rushing” devices to market. The authors write that “our regulators should not be in the business of creating jobs in the manufacture of dangerous devices.”
Stearns didn’t derive his criticisms from his own observations. They came to him from industry constituents and became ammunition in narrow efforts to coerce FDA into better accommodating those constituents.
Curfman and Redberg sensibly argue that there are three things FDA can do immediately to alleviate some of the problems surrounding the 510(k) progress. They write that FDA should ban all Class III devices from the 510(k) program, disallow clearances that rely on multiple predicates, and implement a formal postmarket surveillance program.
FDA, however, has long had an elastic definition of “immediately.” Considering its new political reality, we need not expect early action on these recommendations. User fees have brought the agency into bed with industry, leaving it to outsiders like journal editors and academicians—who presumably don’t know what it’s like to get a device to market—to criticize accommodations made along the way.
If history is any guide, this is a recipe for inaction by the agency. As shown by such examples as FDA’s ponderous handling of controversies over LASIK eye surgery and dental amalgam, the more political an issue becomes, the longer the agency delays its responses and the more important stage management becomes.
The current controversy over the 510(k) process was sparked in 2007, when the Government Accountability Office (GAO) was first asked to assess the program’s adequacy. At that time, the GAO timidly recommended new regulations for Class III devices that go through 510(k). Four years later, there’s still no answer in sight to the broader adequacy question. New budgetary constraints and the preoccupations that will certainly accompany the coming election season are likely to further the agency’s paralysis.