updated 8/10/2004 5:34:10 PM ET 2004-08-10T21:34:10

The Food and Drug Administration has added a layer to its armor to protect against outside influence from the companies it regulates. Now employees must get approval — and confirmation from the agency’s chief — before beginning even unpaid outside activities.

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Joining the PTA or singing in the church choir are among the few guaranteed green-light activities.

Earning spending money by ministering to the caffeine-addicted at Starbucks, however, requires agency approval. The stock-options-issuing coffee giant falls under the agency’s “significantly regulated” industries because it roasts its own beans.

“FDA must be clean and pure,” Les Crawford, acting commissioner, said during an Aug. 2 speech, referring to the more stringent rules the agency imposed two months ago. “We have to watch ourselves.”

The National Institutes of Health, by contrast, in the 1990s eased rules that govern employees’ outside activities to better attract coveted researchers, then found itself embroiled in a conflict of interest scandal that triggered congressional hearings this summer.

One of the two researchers involved in that controversy, Dr. Emmanuel Petricoin, worked at the FDA. Petricoin had accepted tens of thousands in consulting money from Biospect, a company that analyzes blood protein patterns and is subject to agency regulation.

That episode prompted Crawford to form an internal task force that reviewed forms employees file to take part in outside activities, be it chairing their homeowner’s association board to doing freelance writing projects.

“We looked at more than 1,800 outside activity forms,” said Jeff Weber, FDA’s associate commissioner for management. The activity forms covered the previous five years. He said the team’s review unearthed no new ethical breech.

“The vast, vast majority ... had nothing to do with FDA work. It was people trying to earn more money on a second job,” Weber said.

Still, the FDA further tightened its rules for Crawford’s peace of mind.

New changes
The forms now will be reviewed every year, rather than every five years. Only center directors — chiefs of divisions such as food, drugs, medical devices and animal feed, products FDA regulates — can approve those requests. Even more employees will be required to declare financial holdings. And by October, the agency will roll such paperwork into a computer database that’s easy to search, simplifying the task of discovering where employees hold second jobs.

The agency is hardly alone. Already, U.S. Customs employees are barred from taking second jobs with international carriers or legal firms that specialize in customs law. Internal Revenue Service workers cannot recommend an accountant or a tax attorney. And Office of the Comptroller of the Currency employees face restrictions on which credit cards they carry and which loan terms they can accept.

For FDA employees, owning stocks of such agency-regulated companies as Starbucks or Kodak are already no-nos, said Weber, who shed those holdings when he joined the agency.

“Kodak is a regulated company. I think of Kodak as film. More revenue is generated from their medical devices ... than for film. You really have to be careful,” he said.

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