FDA Reform Bill Divides IVD Manufacturers, Blood Industry

Originally Published MDDI February 2002

NEWS & ANALYSIS

Robert Drummond

Reform legislation currently before Congress proposes to give CDRH sole jurisdiction over all in vitro diagnostic products. The "Preparing FDA for the 21st Century Medical Technology Act" (HR 3580), introduced December 20, 2001, by Representatives Anna Eshoo (D-CA) and Jim Greenwood (R-PA), proposes among its provisions to shift the responsibility for all review, inspection, and approval of IVD products to CDRH.

Currently, CBER and CDRH maintain separate organizations for these duties. The proposal has created turf issues between the two agency branches and the groups that support them—AdvaMed and the IVD firms siding with CDRH, the blood industry with CBER.

At the heart of the issue are perceived inefficiencies in the CBER processes. The manufacturers' solution, voiced by AdvaMed in a recent position paper, is to eliminate CBER's involvement in all IVD regulation except at locations that deal with the collection or transfusion of blood and blood products.

"We have the same technologies going through CBER and CDRH," says Glen Freiberg, vice president of regulatory, clinical, and quality systems at Gen-Probe Inc. (San Diego) and a member of the AdvaMed group that supports the legislation. "We don't believe there is any scientific reason for the duplication."

Celso Bianco, MD, executive vice president of America's Blood Centers (Washington, DC), disagrees. He says he understands the IVD manufacturers' frustrations with the CBER review process, but he maintains that shifting all regulatory oversight to CDRH is not the solution. "From our point of view," he says, "the change is unacceptable."

Representatives of the blood industry met with AdvaMed in late January in an attempt to smooth out some of their disagreements. According to Freiberg, both sides agreed to work together to improve the phrasing in the bill.

But Bianco, who was also in attendance, believes the two sides remain far apart. "We are still not happy with [the bill]," he says. "They presented some very cogent reasons why they are unhappy with CBER. We would also like to see CBER become more efficient." But, he says, the AdvaMed proposal merely rearranges the current regulatory scheme without getting to the root of the difficulties. "Simply shifting [regulatory responsibilities] from CBER to CDRH—which at the current time happens to have better performance—is not addressing the problem," he says.

In its position paper, AdvaMed calls the current setup "fiscally irresponsible," and cost is a major concern for both sides. Under the current lot release requirements, IVD manufacturers must provide equipment, training, and maintenance for the CBER laboratories. But if the bill goes through, Bianco says, much of the regulatory responsibility would shift to the blood industry, creating what he calls "a huge burden" that it is "not equipped for."

AdvaMed says CBER's approach to the regulation of IVDs for blood screening is "very cost intensive," and that it "creates a barrier to entry for U.S. companies to serve the U.S. market." Validation interpretation is another problem. With validation concepts in place, CDRH regulates that IVD manufacturers must show that if a process varies, that variation won't impact the assay. Another meeting attendee from the IVD industry explains that "CDRH understands validation. CBER wants to see a fixed process with no variation. We'd like a little more flexibility."

Both sides cite improved efficiency as their main goal. Says Freiberg, "You've got turf issues, you've got emotional issues—what we're looking for are efficiency issues." Bianco says the blood industry agrees, but with a different end in mind. "We would love to work together with AdvaMed to find ways to make CBER as efficient as CDRH," he says—but not to move everything under CDRH's roof.

No one could be reached for official comment from either center of FDA. A member of CDRH's Division of Clinical Laboratory Devices dismissed questions on the matter, saying only, "Ask Congress."

For now, each side is looking for compromise. "I realize they have serious, heartfelt reasons to keep things the way they are," says another IVD manufacturer. "But I don't believe the scientific basis for what we're proposing can be challenged—based on science, based on need."

Bianco says reaching an agreement will ultimately depend on the flexibility of AdvaMed. "At our first meeting, we didn't get there," he says. "But I'm hoping we will."

Copyright ©2002 Medical Device & Diagnostic Industry