Originally published August 1996
Robert L. Sheridan
Vice President for Device Evaluation
C. L. McIntosh & Associates, Washington, DC
Virtually everyone, it seems, is in favor of FDA reform. Such sentiments are not new--even within the agency--but the demands being voiced now are qualitatively different from those of the past. To begin with, they are louder, and they are coming simultaneously from many sectors of society. More important, today's demands are aimed at modifying some of the agency's fundamental operating principles.
So far, however, the agency seems unaware of both the magnitude of the challenges it faces and the potential for adverse results if it does not take an active lead in developing its own new operational methods. If FDA does not take the lead in shaping reform, outside pressures will force the agency into broad swings of policy, and into inadequate, inefficient, and inconsistent regulation--much of which will be detrimental to patients and business alike.
During the past two years, FDA has responded reasonably well to outside pressures, particularly in its device program. The agency is now reviewing premarket notifications (510(k)s) much more quickly than at any time since 1993; wisely or unwisely, it has exempted many Class I devices from 510(k) requirements; it has obtained Health Care Financing Administration reimbursement for investigational devices; it is more amenable to up-front discussions with applicants about their product submissions; and it has modified the very troubling reference list procedures. Given the difficulties inherent in changing bureaucratic systems, these are not small achievements.
With few exceptions, however, the agency has enhanced its performance by fine-tuning established procedures rather than by adopting new models. Third-party review, for example, is a potential new regulatory model. But considerable political force was required to compel FDA to establish its third-party pilot program, and the agency has shown little enthusiasm for expanding that program to more complex devices.
Without implementing some such new operational models, however, FDA will be unable to meet the demands of the 21st century. Most readers would agree that it is neither feasible nor wise for FDA to embrace within its organization all the scientists, statisticians, quality control specialists, and police forces necessary to keep under its central control all the device innovations and related medical procedures that will be developed over the next 50 years. But, even in light of the obviously compelling need to do so, will FDA change? Unfortunately, the nature of the changes made by FDA to date, coupled with what appears to be the motivation for those changes, suggests two troubling answers to this question. Fundamental changes may not soon occur; and, if they do, they will not be satisfactorily effective. Thus, some new strategies should be considered for ensuring that FDA keeps abreast of the public's needs.
It is troubling to conclude that most of the changes that have been effected at FDA--with the exception of those that extend the agency's authority--have resulted primarily from outside pressures. Troubling, because such changes tend to have undesirable features and are not optimally effective.
When FDA designs changes only in response to outside pressures, those changes tend to be merely refinements in existing operational methods. Although they may provide relatively minor opportunities for improvement, they cannot alter the agency's system. Regrettably, such reactivity means that FDA is not using its skills and knowledge to develop other options.
Of course, Congress can force the agency to alter its basic operating principles by amending the Federal Food, Drug, and Cosmetic Act. But without FDA's constructive participation in developing such legislation--and sometimes even with such participation--Congress will often miss the mark. All too often, the burden of creating such legislation falls to congressional staffers who do not have intimate knowledge of FDA's regulations and operations, and the laws they write frequently create unanticipated problems, fail to solve the problems they were intended to solve, or even fail to address the very issues most critical to improving FDA operations. In addition, political and philosophical persuasions on Capitol Hill can change remarkably fast. Congress cannot be relied upon to manage FDA steadily over an extended period, nor is it really supposed to do so.
The relations between FDA and Congress become still more complicated when one factors in the considerable pressures of the executive branch and the media. In the past, whenever the legislative and executive branches have been under the control of different political parties, Congress has endeavored to embarrass the various federal agencies under the control of the administration. This has been a major factor underlying many of the oversight hearings conducted to deal with both real and fabricated FDA failures, and the agency has rarely had the fortitude or skill to withstand such congressional criticism or to win the battle for public opinion. In the face of such intense media scrutiny, it has been easier for FDA to move to a higher level of regulatory control than to explain why a program that tolerates well-calculated regulatory risks is more beneficial than injurious.
With elections looming once again, it is not unreasonable for the device industry to be concerned about what might happen in 1996. Should the results of this November's elections be the primary influence on defining FDA's programs for the next several years? Should the next commissioner's personal philosophy, political aspirations, or capacity to face down potential criticism dictate the nature of the agency's programs for the foreseeable future?
Fortunately, FDA need not be at the mercy of such events and personalities. The agency can accomplish true advancements in its device program by effecting its own changes, which should include the following:
* Depoliticize the agency's device regulation program.
* Create a balanced media program to inform the public about the risks inherent in new medical-care systems, even in a regulated environment.
* Offer greater latitude for physicians to practice medicine without FDA intrusion, even when the procedures require liberal discussion, labeling, and use of general- purpose or physician-manipulated devices.
* Make greater use of outside resources to accomplish FDA's mission.
* Recognize that marketing approval should not be the centerpiece of device regulation.
In turn, achieving these goals will require two further accomplishments: a closer, ever-present cooperation among academicians, health professionals, manufacturers, and federal regulators; and an FDA management system designed to ensure the constancy and effectiveness of agency activities and to continually evaluate adjustments to the system.
One way of improving the odds that any of this will happen is to have FDA managed by a commission rather than a commissioner. Such a commission could be designed in any number of ways. For instance, it could be required to include representatives of academia, the health professions, industry, and FDA's civil service. Its members could have tenures that would expire nonconcurrently and overlap presidential terms.
Functionally, such a commission could compel FDA to consider all of society's needs when making policy, and would make the agency more responsive to changes occurring in the environments represented by its members. It would be charged with maintaining stability and order, but also with continuously considering how FDA should adjust its operating programs. Most important, it would eliminate the potential for FDA policies to be dictated by a single person throughout his or her tenure.
The idea of instituting a commission at FDA deserves serious consideration. But however compelling the arguments in its favor, it is still only one of many such reform proposals that should be explored. What is more critical is that all such ideas be made the subject of study within the agency. FDA needs to change itself, but it cannot do so without the introduction of some institutionalized method for achieving that end.