Medical Device Link.

Originally Published MX September/October 2003

COVER STORY

Medtech manufacturers have not been neglected among the many initiatives launched by FDA under the direction of Commissioner McClellan. Early in the year, the agency announced a major new medical technology development initiative intended, in the commissioner's words, "to make sure we have regulatory processes that are as efficient and up-to-date as possible." The three main elements of the initiative are described below.

Reducing Cycle Time. The agency has conducted a root-cause analysis of recent multiple-cycle product approvals—products that required two or more rounds of review before they could be approved. "Often, multiple cycles do not appear to be FDA's fault," McClellan told the annual meeting of FDLI in April. "But in our preliminary analysis, it appears that in some cases, early communication and more transparency in our regulatory requirements might help avoid multiple cycles."

McClellan noted that the agency was in the process of implementing two prescription-drug pilot programs in order to evaluate "the impact of extensive early communication and of reviewing pieces of an application for potential problems as they come in, rather than waiting for a complete application."

Quality Systems for Product Review Procedures. "The idea is to build on our professional staff expertise to identify and apply best management practices internally to our review processes," McClellan told San Francisco's Commonwealth Club in June. "This includes using peer-review programs coupled with more empirical data for drug and device reviewers to exchange ideas and use each others' experience to learn about best practices—much as clinicians are increasingly doing today."

In April, McClellan told FDLI that the agency also expected to develop "performance measures designed to make sure we're approving safe and effective treatments as efficiently as possible."

Guidances. The third element of the agency's medical innovation initiative is to publish new guidance documents in areas where it believes regulatory pathways could be improved or better defined. "We expect to learn something from outside experts in the open process of developing the guidances," McClellan told FDLI.

"These are in a tradition of FDA documents that serve as roadmaps for drug and device developers, offering guidance on how to structure studies to prove that new treatments work," McClellan told the Commonwealth Club. "These new documents represent an enhanced effort to combine our internal expertise with input from outside experts to make sure that our regulatory methods are up-to-date in important areas of technology development.

"Some of the guidances will focus specifically on diabetes, obesity, and cancer. Despite all the innovation that's already occurred, these are therapeutic areas that remain underserved by effective treatments and that have promising technologies under development today. We're also developing guidances in new areas of technology development—including pharmacogenomics, novel drug-delivery systems, and cell and gene therapy."

"In these critical areas," McClellan told FDLI, "we think that new regulatory standards can reduce the time and cost of product development. That, in turn, should lead to more investment in much-needed new products."

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