FDA's Pharmaceutical Inspectorate Searches for Higher Ground

“When I look at inspection reports from the past few years, they always describe what questions were asked, and I haven’t seen anything said about risk in any of them,” Huber says. “There’s a big difference between the theoretical and practical and this is what the training should focus on.”

To be fair, Huber says that FDA is actually ahead of industry in its emphasis on risk-management techniques, and more companies need to develop and improve their risk-management master plans to keep pace with FDA.

“It’s wrong to say investigators haven’t been concerned about risk,” says FDA’s German. “We have had for two, three, four years a work plan for inspections based on risk. So it’s not a foreign term. We’re just nurturing, building and cultivating that concept.” The latest risk analysis models and tools are a key focus of the second module of training, and are already working their way down to the field level.

Experience drain

Despite progress, it's likely that not all of the PI will rise to the challenges, and some turnover is inevitable, says Aegis Corp.’s Neway. The more critical concern, he says, is whether or not the Agency can keep its best and brightest investigators, especially the most highly trained. “You see a migration of FDA-trained people out into the industry,” says Neway. “What a loss! The FDA is just less attractive to them as a career.”

There is a “major deficiency” in the ranks of investigators, Anisfeld agrees. “You could overcome it by hiring people from industry, but the salary would have to change dramatically and that’s not going to happen.”

The new training and certification program exacerbates the problem. Those who join the Pharmaceutical Inspectorate will become eminently more desirable to private industry. “The real problem is that if inspectors don’t earn more, they will have even more motivation to leave,” Huber says. He estimates that an experienced, reputable FDA investigator could earn two to five times an FDA salary in the private sector.

According to FDA’s salary table for 2003, a beginning investigator at the GS-5 level can expect to earn up to about $30,000 annually. A GS-12 specialist earns between $50,000 to $70,000, and a GS-13 between $60,000 and $80,000. There are, of course, plenty of perks with government service. But when recruiters from major pharmaceuticals or consultancies come calling, promising six figures, what is to keep Inspectorate members from jumping ship?

Commitment, says Mazanec of Bright Associates, who notes that the swinging door goes both ways: As a trainer, he frequently gets inquiries from industry personnel interested in joining the Agency. “Some are enamored with the concept of being an investigator,” he says.

History repeats

In his 33 years with FDA, Mazanec served as a drug investigator in Seattle and Philadelphia, supervised in Chicago and Los Angeles, directed investigations in San Francisco, and ended his Agency career six years ago as assistant regional director in the Pacific regional office.

Speaking from vast experience, Mazanec says the new training initiative is merely history repeating itself. “I view it as someone trying to lay claim to inventing the wheel,” he says. In other words, this isn’t the first time FDA has tried to remake itself and revamped its drug training initiatives.

There was a time, Mazanec recalls, when FDA recognized experts and highly trained personnel with what were known as 200C credentials. He spent three weeks at the University of Rhode Island, and later two weeks at the University of Pittsburgh, after which he received what he received what he calls his “racing stripes.”

A few years later, he had them taken away. “The Agency eventually decided it’s not a good idea to have people with special credentials,” he says. “When investigators had other kinds of work to do, like in the medical device area, they said, ‘No, I have special credentials.’" Unions supported this stance, Mazanec says. This led the Agency eventually to designate some of its investigators as specialists in the field.

The Pharmaceutical Inspectorate might not be anything new, in Mazanec’s view, but that doesn’t mean it’s such a bad thing. “A rose is a rose is a rose,” he says. “The motive is still the same. You’re always going to try to have people appropriately trained to do their jobs.”

Will firms notice any changes in the way inspections are done, with a member of the PI leading the proceedings? Not really, says the Agency. “I don’t think there’ll be much difference in the inspections,” says FDA’s Doug Ellsworth, director of the New Jersey district office and chair of FDA’s Field Drug Committee, “but when firms begin to use more of the advanced technologies and techniques, the Pharmaceutical Inspectorate will understand what industry is doing and be able to apply their normal inspection approach. The training is preparing them for the future of the pharmaceutical industry.”

THE PHARMACEUTICAL INSPECTORATE CURRICULUM The following curriculum outlines the training for the Pharmaceutical Inspectorate. Trainees will visit FDA headquarters in Rockville for just three week-long sessions over the course of a year to complete the seven modules. The first session, which took place last August, covered the first three modules. The second session, in late January and early February of this year, tackled Modules 4 and 5, while the last session, later this spring, will be devoted to the final two modules. Following the three sessions, trainees will be assessed for additional wants and needs, then return to Rockville in the fall to spend time — from one week to more than one month, depending on the individual — in close contact with experts in the Centers in order to reinforce lessons learned in training and fill in knowledge gaps investigators may still have. A certification board comprising Center experts, experienced field investigators and others will then review the candidates for certification. The exact means of final evaluation have yet to be determined, but will likely include written tests and performance audits. Module 1 – Regulating Pharmaceutical Quality and the Relationship to FDA’s Mission Module 2 – Risk Management Module 3 – Advanced Quality Systems Module 4 – Pharmaceutical Science Module 5 – Current Regulatory Programs and Procedures Module 6 – Technology Module 7 – Investigational