FDA's decision to reorganize the Office of Regulatory Affairs will cause a "slow motion effect" for industry's interaction with FDA, according to a dietary supplement trade group executive.

United Natural Products Alliance Executive Director Loren Israelsen said the reorganization described by an FDA regional director March 12 will "slow things down."

"Clearly what it means is that our ability to get hold of FDA to discuss, maintain effective discussion or collaboration will be diminished," Israelsen said in an interview March 22.

Gary Dykstra, food and drug director for FDA's Atlanta-based Southeast region, announced the agency's plans for reorganizing ORA and for closing seven labs at a conference in Athens, Ga.

The reorganization will close all regional offices, effective Oct. 1, Dykstra said at the International Good Manufacturing Practices Conference. All concerns that have been addressed to regional offices will go to district offices.

District offices will cover larger areas, while their number will be cut from 20 to 16. Some offices, such as those in Philadelphia and New Jersey, will be combined, Dykstra said.

The reorganization will also have a more "centralized" management structure, he said.

Additionally, the reorganization will close seven laboratories, leaving six in place. In December, ORA announced a plan to close several laboratories, but did not indicate which sites (¹ Also see "FDA Will Close Labs As Spending Is Locked At 2006 Levels" - Pink Sheet, 8 January, 2007., p. 9).

Groups such as the Public Employees for Environmental Responsibility and the National Treasury Employees Union have said they are concerned about the plan (² 'The Tan Sheet' Feb. 19, 2007, In Brief).

And 20 senators sent a letter to ORA in January suggesting the planned lab closures undergo congressional review (³ Also see "Senators Ask ORA To Halt Lab Closure Pending Congressional Review" - Pink Sheet, 5 February, 2007., p. 13).

Dykstra said the agency is in "a bit of a holding pattern with regard to laboratory closures" because of Capitol Hill's interest.

However, FDA is not using 200,000 square feet of the approximately 500,000 square feet of space available in its 13 laboratories, he said.

"Well, what's the natural conclusion? We have too much space. And we're paying for it; the taxpayer's paying for it. You have got to do something with that knowledge," Dykstra said.

He said money and staffing are the "driving force" behind the decision to reorganize ORA. "We are being driven by the fact that FDA is a shrinking organization, particularly in the field."

"We are an organization that was designed to operate with 4,000 people," Dykstra added. "We are now down to almost 3,000 people. It is necessary when you lose a significant amount of your staffing. You have to look at your organization and make sure that you are making changes to adjust for those staffing numbers."

Israelsen said FDA's reorganization "simply confirms what [he and others in the industry] have been saying for some years now ... that the agency has been under-funded" and understaffed.

"It's simply the math. There are fewer people; they're farther away, [but] they have more to do. They will become, by definition, less responsive, simply because they can't be more responsive," he said.

"So the takeaway message for me is, it simply reconfirms the need for our industry, among many regulated by FDA, to recognize that if we want to maintain the public's trust and confidence with regard to the safety, value and utility of our products, we're going to have to do much of that work ourselves," Israelsen added.

Another option Israelsen entertains is imposing user fees for the food industry.

"That raises a really interesting question, one that will be debated really hotly, whether that's a good idea or bad idea," he said. "The upside would be, FDA would generate more resources with which to regulate industry. But if industry is paying the tab, there's an expectation, as you see with faster drug approval. How does that actually benefit the industry itself?"

- Rebekah Moan (r.moan@elsevier.com)

FDA To Close Regional Offices, Consolidate Districts Under ORA Reorg

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