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FDA’s Critical Path

Originally Published MDDI June 2004EDITOR'S PAGE

July 1, 2004

4 Min Read
FDA’s Critical Path

Originally Published MDDI June 2004


An upcoming initiative could play a major role in setting the tone for how FDA and industry interact in the 21st century


Several years ago, Congress made a commitment to medical research by tripling the budget for the National Institutes of Health.

That's all well and good, but it won't amount to much unless patients get rapid and regular access to the treatments and technologies that are developed as a result of that research. Considering that new-product applications to CDRH and other FDA centers have lessened in recent years despite many firms increasing their R&D budgets, a lot of work remains to be done.

In a perfect world, Congress would also have tripled FDA's budget. But that didn't happen, nor is it likely. 

Instead, it is up to the agency and the industries it regulates to do a more efficient job of turning research breakthroughs into safe and effective medical products available to the public.

CDRH, the device industry, and Congress took some positive steps toward reform in 2002 with the writing and passage of the Medical Device User Fee and Modernization Act. But that cannot be the last word on this topic. The jury is still out on the user-fee system, but it's gotten off to a rocky start with Congress failing to appropriate most of the additional CDRH funding the law calls for, and the smaller device companies unhappy at the large annual user-fee increases seen so far. Indeed, at the Medical Device Manufacturers Association (MDMA) annual meeting in June, members were adamant that the user-fee system undergo major changes or be scrapped altogether. Because Congress did not come through with the promised funding, industry has the right to call for revisions. MDMA, which represents mostly smaller device firms, has made it clear that it will do just that.

This is one reason why the next reform initiative will be so crucial. The Critical Path Initiative, to be unveiled shortly after Labor Day, will represent a new era in FDA-industry collaboration, acting-FDA-commissioner Lester Crawford told the MDMA meeting audience. On top of that, he said, it will usher in a new era of coordination and cooperation among all agencies in the Department of Health and Human Services.

Full details, of course, won't be known for a few months. But Crawford indicated that the most significant developments would involve FDA's review practices.

“This is a new FDA; a new culture has been constructed,” he said. “Now we are doing some things to make it permanent. A number of new guidances are coming out.”

One priority will be to reduce multiple-cycle reviews, which will involve better communication between reviewers and applicants. Another will be to create a “root cause evaluation system” which will analyze applications that failed or spent too long in review to determine what could have been done better. “We need to move to make reviews a predictable science,” Crawford said. He noted that much of the Critical Path Initiative would consist of science-based tools covering three main areas: product safety, modal utility, and manufacturing.

Another goal of the initiative is to better prepare the agency to foresee and react to major breakthroughs in research, development, and manufacturing of devices and other medical products. “FDA generally has not been ready for major developments,” Crawford said. “In fact, it has often served as an impediment. We don't want that to happen again. We simply must be able to deal with it.”

To help, the agency will create an Office of Critical Path Opportunities. It will forge collaborations between the agency, industry, clinicians, and the academic community to assess where breakthroughs are occurring and analyze how FDA can prepare for them—even down to changing policies. 

It is much too soon to tell how this initiative will play out in practice. But credit must be given to FDA for trying. The healthcare landscape of the 21st century will be radically different from that of the 20th century, and FDA's approach to it must be equally radically different.

The Editors
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Copyright ©2004 Medical Device & Diagnostic Industry

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