James Ravitz09.07.06
FDA’s Latest Initiative Focuses on Improving Device Review Times
By James R. Ravitz
Arent Fox PLLC
On May 22, 2006, the FDA’s Center for Devices and Radiological Health (CDRH) announced that it is initiating a new program that is intended to speed the approval and introduction of new, “innovative” medical devices into the marketplace. The Medical Device Innovation Initiative (MDII) is the CDRH’s answer to the Critical Path Initiative, a program that the FDA launched in March 2006 to improve and stimulate medical product development. The agency established the Critical Path and MDII to improve its internal systems and capabilities, thereby helping reduce delays in review processes to ensure new, “innovative” products are reviewed (and approved) in a timely fashion.
The MDII is yet another effort to upgrade the FDA’s medical device review program; such measures have been occurring since the passage of the Medical Device User Fee and Modernization Act (MDUFMA) in 2002. However, several of the MDII’s components—such as meeting with device applicants early in development process—already were in progress before the new initiative was announced. It’s not surprising, then, that some industry executives may be viewing the FDA’s latest endeavor as little more than a reinvention of programs already in progress.
MDII Reminiscent of Past Endeavors
Promotion of scientific innovation and improvement of device review times are not new concepts to the FDA. Both Congress and the FDA acknowledge that the agency can act in numerous ways to protect public health—the most obvious being that medical products entering the marketplace are safe and efficacious. Indeed, this is the agency’s basic mandate.
The FDA’s regulatory framework is another consideration in ensuring that public health is protected. Historically, the agency’s framework has adjusted to change to slowly. Over time, however, it has become clear that the FDA needs to adapt quicker enough to encourage technological innovation.
In other words, the FDA should encourage device innovation so that patients have access to the most advanced therapies as quickly as possible. Unfortunately, companies with novel technologies have been known to run into a regulatory wall that ultimately prevented or delayed product commercialization.
This isn’t the first time the FDA has been charged with improving its processes and fostering innovation in the medical device industry. The passage of the Food and Drug Administration Modernization Act of 1997 (FDAMA) was an example of Congress legislating a kinder and gentler FDA in an attempt to encourage the development of novel medical technology and improve device review times.
The FDAMA mandated the agency to adopt the “least burdensome approach” to companies submitting applications to market their medical products. This mandate required the FDA to develop methods for expediting product applications, issue industry guidance and conduct pre-application submission meetings with companies.
The features of the MDII are reminiscent of FDAMA’s intent—ie, speed development of new guidance documents for new, innovative technologies in an effort to shrink development times and provide clear pathways for novel technologies. The Critical Path and MDII both reaffirm the FDA’s commitment that public health can and should be protected through the encouragement of innovation.
How MDII Will Streamline Device Review
Key features of the MDII are promotion of regulatory clarity through the issuance of industry guidance and modernization of the FDA’s review of new devices. In particular, the agency believes that the availability of guidance promotes more efficient device development. Product applications will be more complete and, as a result, will encounter fewer regulatory hurdles during the review process.
To help accelerate the development of new guidance, the CDRH is now prioritizing its efforts to focus on developing guidance that it believes will foster innovation. For example, just after the announcement of the MDII in May, the agency published Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials to improve clinical trial efficiency. The FDA promises that additional new guidance documents are forthcoming on topics such as drug-eluting stents, combination products for cartilage repair and genetic/pharmacogenomic tests. However, since the FDA has limited resources and cannot issue guidance documents fast enough (or specific enough) to address all issues of safety and efficacy that arise with new technology, it’s uncertain whether these guidance efforts will translate into practical results.
In addition to guidance, the CDRH also promises to collaborate more with the industry to “modernize” the process by which medical devices are evaluated and to improve communication between the agency and med-tech manufacturers. The FDA hopes that its efforts to develop new science and increase the expertise of its laboratory and review staff will help reduce the investment of resources a device firm must allocate to demonstrate the safety and efficacy of new technologies. For example, the agency recently implemented an internal quality review program for pre-market applications so it can identify areas where improvement may be needed (eg, increased reviewer training and expansion of scientific expertise).
Time Will Tell
The announcement of the new initiative comes at a critical time for the FDA, as the agency is currently engaged in efforts to reauthorize MDUFMA, which expires Oct. 31, 2007. One year ago, the agency was forced to delay its announcement of user fee rates for FY 2006 because it had “under spent” (on medical device programs) the amount specified under MDUFMA. The matter was resolved when Congress intervened by passing the Medical Device User Fee Stabilization Act of 2005, which extended the user fee program. Approximately one year ago, MDUFMA’s sunset provisions nearly put an end to the device user fee program.
Beginning next month (Oct. 1, 2006, which begins FY 2007), new device user fee rates will take effect. Since medical device user fees went into effect for FY 2003, the cost of submitting a PMA application to the FDA has risen from $154,000 to $281,000 for FY 2007—an increase of nearly 100% in four years! However, during the same period, the device review process has had only incremental improvements, including a reduction in the time it takes the FDA to review and approve medical device applications.
Based on that knowledge, the CDRH’s recent announcement of a new device initiative may, in part, be the agency’s way of demonstrating that it is starting to invest user fee dollars in earnest for the betterment of the device review process. Hopefully, the long-term impact of the initiative will prove to be positive for industry. The FDA has demonstrated that there is still much work to be done to ensure that there will be practical effects associated with its Critical Path and MDII initiatives.
There is little doubt that the FDA is committed to fulfilling its mandate as a public health agency. However, it continues to struggle with becoming an agency that can adapt to change. It’s been almost 10 years since the enactment of the FDAMA, and the same issues are being discussed. In the agency’s defense, keeping pace with the device industry’s technological advancements is a challenge.
The med-tech industry hopes that the user fees will translate into tangible results—ie, faster review times. Time will tell whether the FDA’s latest initiative will benefit the industry and overall public health or if it is just a new label on the same old box.