Diagnostics & Imaging Week Washington Editor

ARLINGTON, Virginia — The worlds of biologics and devices are increasingly coming closer together and, on occasion, overlapping.

"On the device side, biologics really has changed over the last two or three years," Jesse Goodman, MD, director of the FDA's Center for Biologics Evaluation and Research (CBER), told attendees during the recent 15th annual Device Submission Workshop presented by the Advanced Medical Technology Association (AdvaMed; Washington).

And the numbers clearly back up Goodman's claim.

Since 2002, the number of 510(k)s that fall under biologics device applications has risen steadily: 40 in 2002, 56 in 2003, 78 in 2004. So far this year, there have been 36, with four months left in the current fiscal year.

Many people, especially the general public, fail to realize just how important the device/biologics connections are, Goodman said.

"People don't often realize the sensitivity of some of these blood devices," he explained as an example. "It is very clear what the health impact is when you have a pacemaker, a catheter or defibrillator that isn't working. But if you have a problem with a blood bag, all of a sudden you could have a situation where half of a blood supply is affected by a minor problem with a bag."

The potential impact of both is just as great, he added.

Traditionally, CBER regulates the medical devices involved in the collection, processing, testing, manufacture and administration of licensed blood, blood components and cellular products.

Goodman said some of the biggest tests and screenings to come through his center most recently include blood donor screenings for West Nile virus in addition to rapid oral tests for HIV/AIDS and testing for hepatitis.

Other recent device approvals include testing for tissue and organ donation, barcode scanners for blood donor matching and computer-assisted interview systems for blood bank processing.

Some future device needs singled out by Goodman include tissue engineering, catheters that deliver cellular therapies, emerging infectious disease testing, pathogen removal and inactivation at the point of care, blood component storage and longevity, and new delivery systems for biologics.

Some of these are longer-range goals, he said, because funding for some of these projects is lacking in the private sector, which tends to focus more on "blockbuster drug development," he said.

"But there are lots of opportunities here for new product development," Goodman added.

He described an atmosphere of "collegiality" between CBER and the Center for Devices and Radiological Health, saying the two centers share in their mission not only to act as watchdogs of device safety and effectiveness but also as contributors to the overall public health improvement.

Philosophically, Goodman said of the FDA: "There is the importance of being a pre-eminent regulatory authority. Now is not the time to sit on our regulatory laurels. It is time to exercise leadership globally."

That should not be confused with "running everything," he clarified, but is more about becoming increasingly involved in and aware of the greater global community.

"Diseases don't respect geographic borders," he added, explaining, as an example, that regulatory actions in the U.S. can have an effect on infectious disease control efforts in Africa.

Goodman also used the opportunity to weigh in on the ongoing post-market study debate. "If we're doing a post-market study, let's actually answer questions and not just do one to make people happy," he said, explaining that there is a "quality approach" to gathering data after a product approval.

"I'd rather see one really good study that tackles a central question," Goodman said, "than three or four unfocused studies."