Medical Device & Diagnostic Industry
HREF="/mddi/by_issue.html">MDDI Article Index
An MD&DI January 1999 Column
A year after the FDA Modernization Act was signed into law, a top HIMA official assesses the benefits of the new provisions and raises ongoing concerns regarding future implementation.
This article is excerpted from the testimony of HIMA executive vice president James S. Benson before the House Commerce Committee hearing of October 7, 1998one year to the day from the passage of H.R. 1411, which ultimately became the Food and Drug Administration Modernization Act of 1997 (FDAMA).
Anniversaries are a time for reflecting on the past, assessing the present, and setting a future course. In that spirit, allow me to recall for you . . . the underlying purpose and promise of FDAMA, express our concerns about FDA's implementation of the law, and share a vision for the future.
For years prior to the enactment of the new law, the medical device industry was facing increasing development and review times, which threatened the viability of this industry. Review times were far in excess of statutory time frames. Manufacturers were faced with inconsistent, unpredictable, and overly burdensome requirements. Unacceptable bureaucratic hurdles abounded in the system. As a result, the delivery of important technological advances to patients was delayed or, in some cases, denied. Products were regularly available to people outside the United States years before American citizens could benefit from them. We feared the decline of America's primacy in medical research. We saw the beginning of an exodus of our scientific infrastructure to areas of the world with fewer regulatory barriers. It was clear that immediate steps needed to be taken to reverse what could have been a disastrous end result had Congress not intervened.
In all fairness, during the legislative process, CDRH began taking steps to right the situation. In fact, some of the reforms contained in the law codify FDA's own initiatives. Even before FDAMA was enacted, review times were turning around and the backlog of pending applications was shrinking. FDA continues to deal creatively with the challenges that invariably arise when faced with the complex issues and work load presented by regulation of medical devices. Reengineering initiatives such as the new 510(k) paradigm, the PMA modular review, and the product development protocol are designed to work synergistically with the new law to create a new and improved agency. These initiatives are having a measurable positive impact on the way the agency does business.
However, much of the progress that we have witnessed may not have been possible were it not for the interest and the work of this committee. Let's step back a moment and reflect on several highlights of FDAMA from a medical device perspective.
HIGHLIGHTS OF FDAMA
Clear Mission Statement. For the first time, the agency has a specific statutory mission statement that reflects the need for FDA to "promote the public health" by taking prompt action to review medical devices. In other words, FDA's mission is both to protect the public from unsafe products and to make sure safe products are available to patients "in a timely manner." Congress struck the theme. Many of the provisions of FDAMA are orchestrated to support that theme. If the theme is executed as Congress envisioned, the results will help countless patients who can benefit from new and improved medical technology.
Improved Governmental Processes. As President Clinton proclaimed on signing FDAMA, "This Act . . . will ease the regulatory burden on industries, protect consumers, and cut red tape . . . making government operations faster and more efficient." The new law holds forth the promise that taxpayer dollars will be spent wisely and well on appropriate functions. It establishes a new direction for FDA. It should help create a climate conducive to the innovative, iterative process that characterizes the evolution of devices. In other words, in the new, user-friendly environment promoted by this legislation, companies should be able to look to FDA to help them bring new helpful technology to the marketplace in the most efficient way possible.
Patient Benefits. FDAMA facilitates patient access to technology. It does so by creating efficiencies in the two major ways in which products come to marketthe premarket notification (510(k)) program and the premarket approval (PMA) program. It also does so by creating new statutory rights of access by patients to investigational devices under certain circumstances. It makes the requirements governing devices for smaller patient populations with rare conditions more rational.
Predictability, Consistency, and Harmonization through Use of Standards. One of the more important provisions of FDAMA is the requirement for FDA to recognize standards developed by national and international consensus organizations. Full implementation of this provision will mean greater predictability and consistency in the review process. It will help erase the differences among various countries' regulatory requirements to the extent that international standards are recognized by FDA. It will allow FDA staff to spend more time on riskier devices. Some time will appropriately be spent on participating in the consensus standards development process. This has the corresponding benefit of contributing to FDA's need to stay on top of the science associated with standards activities.
Collaborative Process. In FDAMA, Congress explicitly provided for interactive meetings between industry and FDA at key points in the device-submission process. This collaborative approach to resolving issues involving the more complex and breakthrough devices is intended to foster device development and speed products to patients.
Efficient Use of Taxpayer Dollars. Many of FDAMA's provisions are intended to redirect FDA's increasingly scarce resources away from unnecessary functions into core tasks that are essential to its public health mission. These include exemptions of low-risk devices from the 510(k) process; third-party review of certain devices; an efficient alternative classification system for novel devices that do not require full-scale premarket approval; and the ability to file simple notices for certain manufacturing changes and changes to investigational devices, including certain changes to clinical trial protocols. These reforms should allow FDA to redirect resources to activities associated with more complex devices.
President Clinton signed FDAMA into law on November 21, 1997. Many of the provisions were to take effect 90 days later. While it is still too early in the implementation process to have a complete picture of the extent to which FDA is executing both the spirit and the letter of the law, we do have some early information suggesting trends.
Noncollaboration Policy. CDRH has done yeoman's work in implementing the many device provisions contained in FDAMA. Guidance documents and regulations have been issued in a timely manner. Many are straightforward and procedural. Others are problematic. Soon after FDAMA was enacted, we offered to work with the agency to develop guidance documents for the more complex provisions that might benefit from the expertise and experience of the device industry and others. However, earlier this year, the agency announced it would not discuss details about FDAMA implementation prior to the public issuance of implementation documents. We believe this policy to be contrary to Congress's clear intent that the post-FDAMA era was to be marked by cooperation, collaboration, and closer communication with the regulated industry. There are many examples of past collaborative efforts between industry and the agency that have resulted in excellent products that would not have been possible without the synergistic exchange that characterizes these efforts. We believe the process has suffered as a result of this edict. Perhaps the agency should have been less concerned about issuing the large volume of guidances and other implementation documents within such a short period of time and more concerned about producing the best possible documentsinformed by industry and other appropriate parties in the spirit of collaboration envisioned by FDAMA.
Reviewer Commitment to Letter and Spirit of FDAMA. Another general area of concern HIMA has about implementation of FDAMA stems from reports we have received from many of our members that the clear message of FDAMA has not yet been heard by the reviewers who are at the front lines of the agency. These front line "soldiers," who have enormous responsibility and are good solid scientists, are the most immediate contact for manufacturers seeking product approval. This makes it all the more important that FDAMA's clear message of collaborationthe "new marching orders"be heard loud and clear. Perhaps the most difficult challenge for FDA's leadership is to change the organizational culture to reflect the new spirit of the legislation.
Least Burdensome Means for Showing Effectiveness or Substantial Equivalence. One of the more important provisions of FDAMA is the requirement that the agency consider the "least burdensome" appropriate means of showing effectiveness for PMA products. For 510(k) products, the law requires the agency to consider the least burdensome means of showing substantial equivalence when there are technological differences between the device and its predicate. The agency has not included reference to this provision in any of the FDAMA implementation documents. Some reviewers seem not to be familiar with the requirement or appear to discount it. There are legitimate differences of opinion as to what constitutes an acceptable study protocol, statistical approach, or other elements of proof required by FDA. When a manufacturer suggests a less burdensome, but equally valid, means to meet the regulatory requirements of the law, it should not be summarily rejected but should be given serious consideration. We urge FDA to rethink its approach to these important provisions and promote their underlying intent and understanding with reviewers and managers alike.
Dispute Resolution. The agency's implementation of the dispute resolution provision is another issue that is troublesome to us and ties into the previous issue of least burdensome means. When there is a difference of opinion between the agency and a manufacturer, for instance, on the type of data or size of the trial needed to prove effectiveness, and the dispute is scientifically based, FDAMA envisioned an independent, stand-alone, prompt review mechanism to resolve the dispute. The proposed regulation implementing this section is no more than a minor amendment to an existing general appeal mechanism. FDA recently decided against issuing a final rule at this time on this subject, citing substantial adverse comment. We urge FDA to adopt HIMA's proposal to address this provision through establishment of a roster of experts with diverse knowledge about devices and disease states, several of whom could be convened on short notice to hear these disputes. Such experts would be expected to have current conflict of interest clearances from the agency.
Funding. The issue of funding and efficient use of agency resources is one that we raise often in the appropriations context. However, since one of the themes of FDAMA is efficient execution of the law in accordance with statutory time frames, and since such execution cannot be done without appropriate allocation of resources, we believe this issue is relevant for this committee's consideration. We are concerned that funds may be cannibalized from the device program and spent on nonstatutory functions such as tobacco programs. We urge the committee to ensure that taxpayer dollars are being spent first and foremost on implementing the clear mandate of the medical device laws. Funds should not be spent on initiatives that have not been authorized and given priority by Congress.
Dissemination of Information. We would also like to express our concern about the dissemination of information regulation. We share the dismay expressed by Senator Frist (RTN) at the confirmation hearing for FDA commissioner-designate Jane Henney, MD, that the regulation does not carry out the intent of Congress. As presently crafted, its terms impose tight restrictions that practically nullify the ability of manufacturers to make use of this provision. We urge the committee to press the agency to go back to the drawing board and completely rethink its approach to the provision, especially in light of the recent opinion by the Honorable Royce Lamberth in the federal district court case brought by the Washington Legal Foundation. That decision struck down three FDA policy documents that imposed severe restrictions on the dissemination of information regarding off-label uses of FDA-approved drugs and medical devices.
HIMA has been actively involved in commenting on the full array of FDAMA implementation documents. We will continue our efforts to work with the agency to optimize the content of those documents. . . . As we embark on the second year of the post-FDAMA era, we want to refocus on what we hope the future holds for the medical device industry. . . . Key elements of this vision are: patient lives being saved, enhanced, and made more comfortable and less painful through advances in medical technology; productive agency-industry collaboration, cooperation, and clear communication; clearly understood and reasonable rules; speedy, efficient dispute resolution; and wise use of agency resources. We hope we can look back five years from now and all parties can take pride and satisfaction in knowing that this act and its aftermath have contributed enormously to a new and improved FDA, a productive and innovative industry, and, most importantly, a healthier patient population.
James S. Benson is executive vice president of HIMA, a medical device industry trade association based in Washington, DC. He was formerly at FDA, where he served as acting commissioner, deputy commissioner, and director of CDRH.