Originally Published MDDI April 2002
NEWS & ANALYSIS
|Combination products, such as coated stents, raise regulatory issues. (click to enlarge)|
The regulatory challenges posed by combination products are not new, but both industry and FDA are seeking new ways to overcome them. Even as the agency takes steps to reshape its focus on combination products and refine its approach to the issue, new legislation proposes to alter it even further.
In its section on combination products, the 2001 FDA reform bill (H.R. 3580) stipulates that the agency establish an office of combination products and product jurisdiction within six months of the enactment of the provision. The office would assume responsibility for combination product designation and would oversee the regulatory process.
Currently, the task of combination product designation is handled by the FDA Office of the Om-budsman. But the ombudsman's involvement ends after the product has been assigned to a particular center, leaving no one entity to oversee the entire process.
According to Susan Alpert, vice president for regulatory sciences at C.R. Bard Inc. (Murray Hill, NJ), the bill would create that entity and back it up with needed clout. "The goal of the legislation is to get some accountability and authority at a high enough place in the agency that the centers would have to work with that office, and see that the work is done in a timely manner." The office would have the power "to influence the process in all of the centers, and each center would be accountable to it," she says.
Meanwhile—and independent of the legislation—FDA has taken steps on its own to reform the regulatory process for combination products. The agency created the Combination Products Program within the Office of the Ombudsman, and named Mark Kramer its director.
According to Kramer, the program will bring "a more reasoned approach" to combination product regulation and try to "make the process more transparent wherever possible." The program's initiatives include meeting with stakeholders to learn more about combination product issues, developing standard operating procedures for their review, and revising the intercenter agreements.
Kramer, who came to this position after serving in the ODE, and more recently as director of CDRH's staff college, says his role is to be an agency focal point that resolves issues that arise during the premarket review of combination products, and to serve as an agency advocate for sponsors. "What we're hoping to do with the program," Kramer says, "is follow these products not only throughout the request-for-designation process, but actually through their review, to determine and ensure that they move through the system as efficiently as they can."
In effect, the agency has made Kramer the advocate the reform bill requires, which begs the question, is the legislation still necessary?
Jonathan Kahan, whose law firm Hogan & Hartson (Washington, DC) has more than 60 medical device manufacturing clients with combination products, doesn't think so. "I don't believe the current system is perfect," he says, "but I think it's not bad." Because the proposed office would not actually review the products themselves, Kahan thinks the added authority would do little more than aggravate the centers. "Forcing the issue down one center's throat isn't a great idea," he says. "That's why the current idea of reaching a consensus, and using the ombudsman and product jurisdiction officer as referees rather than enforcers, is actually not a crazy idea."
On the other hand, Alpert contends that the key ingredient lacking in FDA's changes is authority. "My guess is there is still distance between [the program's] authority and what the legislation is looking for," she says. Alpert worked for six years as the director of the ODE, and believes that without that authority it will be difficult for the process advocate to make the various centers fully accountable. "The reality is that the centers are not always responsive to each other's needs," she says.
Of course, the reform bill may not pass, or it may not remain in its current form. In the meantime, Kramer will work to improve the review process using the tools and authority he has. "It's unrealistic to expect that combination product review will ever be as efficient as it is with a single product, because these products are more complex and because two centers have to be coordinated," Kramer says. "But it's our objective to make sure it runs as efficiently as it can."
Photo courtesy of Cook Inc.
Copyright ©2002 Medical Device & Diagnostic Industry