On FDA's Front Lines : Part Cop, Part Counselor

by Food and Drug Administration (FDA)

(Page 3 of 3)

Two on a Team

Take Roanoke, Va., for example. That's where MacLaughlin works, along with Dennis L. Doupnik. Although both of them have specialties — MacLaughlin's is oxygen repackers and Doupnik's is illegal sales of prescription drug samples — they are responsible for everything in Southwestern Virginia.

"There's a cosmetics manufacturer down here, an infant formula plant, and lots of medical devices," says MacLaughlin.

And sometimes there's a chance to go undercover.

"It's not uncommon for vets to sell prescription animal drugs without writing a prescription or ever examining the animal," says Doupnik. "So sometimes I'll get an assignment to go and see what I can buy. I must admit, I always want the vet to say no."

In addition to covering the Roanoke area, MacLaughlin and Doupnik are frequently called on to help out other offices in Virginia.

In fact, the oxygen repacker MacLaughlin inspected was in Richmond. FDA has five investigators in Richmond, but one was preparing for a three-week assignment inspecting European drug firms, another was handling seafood inspections, and the other three were relatively new and still learning the ropes.

MacLaughlin's inspection provided a perfect on-the-job training opportunity for new investigator Kathleen Sinninger. A 1989 biology graduate of the University of Richmond, she joined FDA in April 1991.

She was on the job eight months before she accompanied MacLaughlin to the oxygen repacker. A few weeks after those inspections she started inspecting gas repackers by herself.

She admits she was pretty nervous that first time on her own.

"Before I went on the first one, I spent a day going over old [inspection] reports and FDA's guidelines," says Sinninger. "I actually spent more time preparing [for the inspection] than I spent inspecting."

"What if I don't make these changes?" the manager asks as he leans back in his office chair and smiles. "Will you do anything?"

MacLaughlin isn't smiling. He explains the several steps of legal action open to the agency and adds that, "We will do something."

If firms won't cooperate, the first step is usually a warning letter from FDA outlining the violations the company needs to correct. Further resistance can result in seizures, injunctions and prosecutions.

Part Cop, Part Counselor

The priority for investigators is public safety, and since they are part of the public, their own safety is also at stake.

"If I get hit by a car — or, even worse, if my kids get hurt — I want to be sure they're testing blood correctly," says blood bank specialist Morrison.

If she finds problems, her goal is to avert disaster. To accomplish that goal, she explains, "we have to work with them to make sure problems are fixed."

New Unit Fights Crime

Tampering. Counterfeit drugs. Illegal sales of prescription drug samples. These activities aren't just violations of FDA regulations. These are criminal activities, and identifying and arresting the suspects requires special training, skills and equipment.

Although FDA's investigators have always handled criminal investigations along with their regular regulatory inspections, criminal activity involving FDA-regulated products is increasing, says Ronald Chesemore, FDA's associate commissioner for regulatory affairs. In response to the increase, FDA has established the Office of Criminal Investigations and is hiring investigators, officially called criminal investigators, who will focus solely on investigating criminal violations of FDA's laws.

These criminal investigators will have specialized training in criminal investigative techniques. Like other federal "special agents" in agencies such as the Drug Enforcement Administration, the Customs Service, and the FBI, FDA's new agents will be experts in the use of firearms, arrest techniques, undercover operations, and constitutional law.

Terrell L. Vermillion, a former special agent with the U.S. Secret Service, will supervise the approximately 100 special agents assigned to the new criminal investigations office. The agents will be located in OCI field offices in New York, Newark, Miami, Kansas City, Chicago, and San Diego. The agents and supervisors in these field offices will report directly to OCI headquarters.

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.