Medical Device Link.

Originally Published MDDI December 2002

EDITOR'S PAGE

The regulatory scheme for combination products is outdated and inflexible. Despite FDA's best efforts, further legislative reform may ultimately be required.

For many years, combination products were regarded as an important but oddball area of medical product regulation. Though worthy of explicit recognition in the Safe Medical Devices Act of 1990, combination products were still perceived as a somewhat theoretical regulatory problem. To be sure, such products—which combine key aspects of a drug, device, or biological—existed in 1990. But for the most part, they were seen as products of the future, whose potential was yet to be realized.

At the end of 2002, we can safely say that the future is here. The enormous success of drug-eluting stents has brought combination products to the foreground. This new prominence has shown, however, that the existing regulatory approach to combination products is woefully inadequate.

As noted in the lead news story on page 18 of this issue, both FDA and Congress have made significant efforts to correct this deficiency. Early this year, FDA established a central program exclusively to manage the review process for these products. And in its medical device legislation last October, Congress made the combination devices program a formal entity within the office of the commissioner.

While these efforts are a good start, much work remains to be done to improve the smooth regulation of these cutting-edge technologies. One area that must be speedily addressed is the so-called Intercenter Agreements that have governed the regulatory pathways of combination products. As FDA recently stated, "the evolution in technology and scientific knowledge about the mode of action of medical products has in some cases pushed the usefulness of the current Intercenter Agreements past their limits."

The agency expects to update these agreements in the coming months. A thornier problem will be how to update the central concept of "primary mode of action." This is the idea that the main source of a product's therapeutic or diagnostic effect—drug, device, or biological—determines which center should regulate it. But when basing the regulatory framework for combination products on this concept in 1990, Congress did not clearly define the phrase—assuming such definition is even possible.

As the Product Jurisdiction Officer in the agency's Office of the Ombudsman, Suzanne O'Shea is intimately familiar with the concept. At the annual meeting of the Regulatory Affairs Professional Society in Washington, DC, last October, she described in detail the problems it poses. Though assigning products to centers based on the product's primary mode of action may be logical, it is not practical. As O'Shea said, this approach "doesn't allow us to assign combination products based on center resources and expertise."

In addition, the primary mode of action is often unclear. "Lots of people have lots of views of what primary mode of action means. . . . [But] what happens if we don't know how a product works? That happens more frequently than we would like." Even if the primary mode of action is eventually understood, it can be too late to change the decision. "Not so infrequently," said O'Shea, "we find out that we would have made a different decision earlier on. [But] we are very bound by precedent."

FDA held a public hearing on combination products on November 25 specifically to discuss these and related issues. Ideally, the agency will find a workaround solution to the problem of primary mode of action. If not, the future of combination products may once again be within the hands of Congress.

The Editors

Copyright ©2002 Medical Device & Diagnostic Industry