Originally published April 1996
James G. Dickinson
A major FDA final rule on medical device manufacturer reporting procedures has become an unintended test of the agency's readiness to reform itself internally in the face of congressional efforts to inflict reform externally.
While most pundits were predicting in January that general FDA reform simply wouldn't make it into law this year, and as the focus shifted to possible reform legislation for devices only, the reporting final rule erupted in an unprecedented blizzard of substantive industry comments seeking to reopen the debate and test the agency's stated policy of being more flexible and responsive to industry input.
That policy, of course, is a key part of FDA's strategy for diverting and even dissipating political pressure for far-reaching legislative reconstruction of the way it regulates devices, but nobody in the agency intended the reporting rule to be a demonstration project of the strategy. If it was meant to demonstrate anything, the reporting rule, published in the December 11 Federal Register, was meant to show the agency doing business as usual, fairly and objectively, unswayed by the tumult of reform politics.
But on the way to the Federal Register, FDA's final rule ran into the Clinton administration's "Reinventing Government" initiative as interpreted by the White House Office of Management and Budget (OMB). Because you're announcing new forms that industry hasn't seen before, OMB said, you should provide an opportunity for comment on those forms. FDA objected that doing so could open a whole new can of worms affecting the broader rule, but OMB insisted. Naturally, OMB got its way.
Thus, despite FDA's apprehensions, there appeared a most unusual final rule that, because of its poor wording, did indeed let the worms out. Instead of confining comments to the format and content of the new forms, the notice proclaimed at its head an address and deadline for unqualified "comments" and deep in its bowels a solicitation of "public comment on the information collection requirements."
To complicate matters, the final rule with its solicitation appeared in the midst of both blizzard and budget shutdowns of the federal government, causing almost everyone to be late in both noticing its publication and meeting its January 10 deadline for comments. As for FDA's eventual embarrassment when no fewer than 26 entities submitted substantive comments on what was supposed to be a concluded, closed, final rule, few in industry had any sympathy.
"How can you ask for comment on 'information collection requirements' without also expecting to get comment on the information's purposes?" scoffed Health Industry Manufacturers Association (HIMA) director and counsel for technology and regulatory affairs Marlene Tandy. She and other commenters, like Medical Device Manufacturers Association (MDMA) executive director Jeff Kimbell, took full advantage of the unintentional opening FDA had created by asking, in effect, that the "final" rule be rendered nonfinal through an extended comment period. Kimbell asked for another 30 days, Tandy for deferment of the rule for 6 months.
The commenters' unstated but barely concealed bottom line, of course, was the fact that the medical device industry doesn't like any type of reporting. However, given that reporting is the law, the comments sought maximum mitigation of its inconvenience--or, depending on your point of view, the economic damage it does to the industry. MDMA's comments, for example, echoed the well-expressed cynicism of medical industry counsel Larry Pilot of the law firm McKenna & Cuneo (Washington, DC): After 11 years of reporting at a rate of over 100,000 reports a year, Pilot has noticed, FDA has yet to demonstrate any benefits to the public. Yet it was able in the final rule to make the facile statement, "Unfortunately, there are insufficient data to quantify the benefits of the rule."
Of particular concern to HIMA was the final rule's display of a common agency habit--introducing in a final rule a substantive policy element that had not been offered for comment in the original proposal. All government agencies do this regularly. Whether they are challenged on it depends on the degree of impact the new element is perceived to have. In this case, HIMA took exception to the final rule's establishment of a new requirement that foreign manufacturers must designate U.S. agents that will maintain their complaint files. Such a requirement, Tandy said, violates the Administrative Procedures Act and could lead the agency into litigation. Instead, FDA should allow either the foreign manufacturer or the U.S. agent to maintain the files.
Informally, Center for Devices and Radiological Health (CDRH) associate director for compliance Chester Reynolds expects that the 26 substantive comments will be factored into guidance documents that will help to implement the final rule. And there will likely be a deferment of the rule's effective date.
What else the agency can do, squeezed between the dictates of a previous Congress's statutory edicts on medical device reporting and the current political climate, is hard to tell. One thing it and OMB can do in the future, one hopes, is to avoid the policy dilemma created by inviting comments on a final rule when there is no legal, formal intention of doing anything with them.
Although the medical device industry--or at least its Washington representation--remains officially insistent that it won't accept FDA user fees, FDA continues to flaunt the gains being made in drug review times as a lure to persuade the industry to change its mind.
For instance, figures released in January show that FDA's Center for Drug Evaluation and Research (CDER) approved 27% more new molecular entities (NMEs) in 1995 than it did in 1994, a performance the agency attributes to three new assets: drug user fees, better-quality industry submissions, and a new attitude of accountability on the part of the center's drug reviewers.
Calendar year 1995 closed with 28 NME approvals, compared with 22 the year before. In addition, CDER achieved improvements in both median and mean review times. Further, the cohort of almost 100 new drug applications (NDAs) received for review during 1995 encountered only 6 refusals-to-file (6%), compared with 30% in 1994. This reflects a major improvement in the quality of industry submissions, according to Murray Lumpkin, CDER's deputy director for review management.
"The industry has done a good job, they really have," Lumpkin enthused. "They've heard the message on refuse-to-file." From FDA's standpoint, the user-fee program put in reviewers' minds the need to be accountable, to manage the review workload, and to meet or beat the statutory time- lines Congress set for the agency. "It really has gotten into people's mentality that this is important, this is real," Lumpkin said.
Based on the cohort of 1994 submissions, FDA is now approving 96% within the one-year time frame, a much better rate than the 55% goal set for that year's submissions in the Prescription Drug User Fee Act. FDA's statutory goal for the 1995 cohort is to approve 70% within one year, for the 1996 cohort 80%, and for 1997 (when the user-fee program sunsets) 90%. Lumpkin hesitated to predict how much better than 70% the agency will do this year, but said everyone is committed to beating that goal.
The device industry's Washington representatives hate to hear this kind of talk. They have worked extremely hard, with some prospect of success, to con- vince congressional staffs that they should disregard the user-fee panacea and instead craft stringent reform measures that would obviate the need for user fees. Meanwhile, device association leaders have also been draw-ing some comfort from the experience of their drug industry association counterparts, who have begun quibbling with FDA over the methodology used to measure and demonstrate great gains from drug user fees.
FDA has been fudging some of its numbers, and has not been factoring in the greater development delays its new requirements force on drug companies, complain officials of the Washington, DCbased association Pharmaceutical Research and Manufacturers of America (PhRMA). It's all very well to boast that FDA is moving faster at its end of the approval chain, says PhRMA, but it should be honest in acknowledging that some of that improvement comes at the cost of greater delays inflicted on drug companies before CDER sees their marketing applications.
That may well be the case, but PhRMA's argument sounds a little like changing the rules in the middle of the game. Although both sides have done a little midgame switching with the numbers, the inescapable bottom line is that drug user fees have worked to shorten review times.
That doesn't mean user fees are the only way to go in the device area. FDA has improved device review times without user fees, and could doubtless do even better. But user fees are still worth looking at, especially if the legislative reform effort peters out, as many expect it may.
In January, FDA was three months late on a promise it made to deliver a final rule for eliminating conflict of interest among clinical investigators. Naturally, House Commerce oversight and investigations subcommittee chairman Joe Barton (RTX), a tireless agency overseer, demanded to know why. Could it be that FDA commissioner David Kessler (a Republican appointee, after all) was not as energetic as Barton himself in promulgating the ideas of Republican House Speaker Newt Gingrich?
In a January 4 letter to Kessler, the indefatigable Barton picked up on a report of statements Kessler had made on National Public Radio's Diane Rehm Show addressing problems he has with Gingrich's FDA reform ideas. In the letter, Barton quoted the FDA leader as saying, "The real concern I have with [Gingrich's] proposal is that it would turn over the decision making to people who potentially could have certain conflicts of interest. The most important thing that FDA has to offer is that product reviewers are independent."
Barton delved into FDA's April 1994 announcement of the proposed rule on investigator bias to remind Kessler of the importance FDA had then placed on this rule as an answer to a problem that is "significant" and whose solution would "strengthen the FDA review process."
Given that the comment period ended more than a year ago, and given the importance Kessler has personally placed on conflict-of-interest issues, why did the agency miss the initial publication date of October 1995? Barton demanded to know. He acknowledged that a recent FDA regulatory agenda had shown the rule making still to be necessary, and that it is expected by April 1996. Yet that date is 11/2 years after the comment period ended.
FDA does everything much more slowly than even it expects, and the more Barton and his Republican colleagues rein in the agency's budget, the more likely it is that that slowing process will continue. Which, to many who philosophically fear governmental efficiency, may not be an entirely bad thing.
A specialized panel of practitioner experts could be assembled by the American Medical Association (AMA) to provide clinical guidance for FDA device reviewers, AMA vice president Roy Schwarz said after a January meeting with top FDA officials. CDRH director Bruce Burlington was among those who seemed interested in the AMA suggestion, Schwarz said.
Schwarz gave the recent pedicle screw controversy as an example of how such a panel could help FDA. The agency acted against manufacturers' demonstrations of unapproved uses of this device without making any effort to gather input from qualified medical practitioners who had successfully used the screws in off-label ways.
"Let FDA lay the issue on the table and we could discuss as a house of medicine how we might work with them to solve the problem," Schwarz said. FDA said it is willing to discuss the concept further.
James G. Dickinson is a veteran reporter on regulatory affairs in the medical device industry. *