Are You Ready for a New FDA? 1707

FROM THE EDITORS

FDA's impending reorganization of its field offices to "will be massive," noted Mark Roh, FDA's deputy regional director for the Pacific Region. "When we're done, we won't look like we look today," said Roh. He spoke at the RAPS conference in San Francisco in March.

In FY 2008, FDA will embark on a rebalancing and consolidation of offices, and this rebalancing will result in the closing of certain laboratories. Roh noted that the planned restructuring is still proposed, but that Congress is "very close to signing off on it."

In FDA's new structure, the regions will be the interface with the district and headquarters, and the district offices will become part of FDA's new inspection compliance directorate. All of the laboratories will be removed from the districts and will become part of a new science directorate.

"This is a big change. It means the dissolution of the regional offices and the dissolution of several positions within the regional offices," said Roh. He said it means reassigning all the regional positions to different offices and probably downscaling a few positions that are currently in place.

The biggest change—and one that Roh said has caused the most consternation—is that the 20 compliance branches are going to be fused into 10. With this consolidation, FDA will also change the way it handles compliance issues.

Right now, many field compliance issues go directly to the Center office of enforcement and bypass the Office of Regulatory Affairs (ORA) Office of Enforcement, explained Roh. "Oftentimes there have been abuses. We constantly blame the Center for turning down cases," he said.

According to Roh, the new structure will result in FDA putting forth stronger cases. Because the district will be working more directly with the Office of Enforcement in ORA, Roh said, "when we feel we have a case to take forward, they will be with us all the way. They will actually be pushing it."

Under the new system, most actions will go through the Office of Compliance in FDA's ORA before they go to [CDRH], Roh said.

"They will go to the ORA Office of Enforcement for quality purposes to make sure that we did it right and that there's enough evidence to do whatever it is we are proposing to do." Roh went on to say that the Office of Enforcement in ORA will then carry the message to [CDRH} with its recommendation, and "they will work closely together."

Roh emphasized that FDA's purpose in reorganizing its offices is to better serve the public and the industry. "The bottom line is that we want the products we regulate to be safe and effective," said Roh. "Our primary values are the ethics of our operation. We are very proud that [consumers] have consistently voted us at the top of consumer trust, and we want to stay there. And you demand that, too."

This is the biggest structural change at the agency in decades. But, what may be good for FDA could be a bureaucratic nightmare for you and your company. Massive is an apt description. With half the number of compliance branches, you most certainly will see a difference. Make sure you let FDA know what these changes will mean to you.

Sherrie Conroy for the Editors