FDA's Pharmaceutical Inspectorate Searches for Higher Ground

FDA wants its drug investigators to go to a higher level. Can they get there? Will they really make a difference?

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By Paul Thomas, Managing Editor

Twenty-six of the Food and Drug Administration’s top guns — the Agency’s most experienced drug investigators — are now in the midst of a year-long training program. Once trained, they will lead the most difficult, high-risk manufacturing plant GMP inspections. They are the new Pharmaceutical Inspectorate (PI), or, in civil servant speak, Level III Drug Investigators.

In synch with its 21st century GMPs, FDA is reinventing its entire field inspection program to make it leaner and savvier. Instead of rule-based compliance and “equal opportunity oversight,” inspectors will now be guided by scientific principles, prioritizing inspections based on processes and operations that pose the greatest potential risk to consumers.

FDA expects the new Inspectorate to be the vanguard of this brave new regulatory era, helping to spread the gospel of quality systems, risk assessment and advanced science and engineering throughout the ranks of drug investigators. Is it up to the task?

“I’m more optimistic right now that FDA is moving in the right direction than I’ve been in years,” says Jim Akers, president of the consulting firm Akers Kennedy and Associates (Kansas City, Mo.). “The key people are saying all the right things.” Akers, who has done some training for FDA in the past, believes that none of the Agency’s initiatives will matter if the core concepts don’t trickle down into the field, and this is where the Inspectorate comes in. “What we’re talking about is one of the key infrastructure elements that needs to work,” he says.

There will be challenges, though, Akers says. First, it’s no secret that the science and engineering expertise of the investigation cadre needs upgrading. The PI training will help, but perhaps not enough. It’s also no secret that the Agency has faced a chronic “brain drain,” as many of its most qualified inspectors have bolted to higher-paying consulting or industry positions. The PI title could make the most elite investigators even more attractive outside the Agency.

“This is a great, great thing FDA has done,” says Michael Anisfeld, president of Globepharm, Inc., a regulatory consulting and training firm in Deerfield, Ill. “They’ve finally recognized that their inspectors need more expertise.”

Like Akers, Anisfeld isn’t so sure the PI can have an immediate impact. “I’ve been to several of the presentations where FDA has talked about the curriculum, and it all seems good,” he says. “But when I’ve talked to several FDA inspectors, including supervisory managers, they’re basically ignorant of what’s going on. It hasn’t trickled down to the field yet.”

The training is designed to address these issues and others. While the Level III investigators will be managed and given site assignments by the Office of Regulatory Affairs in the field, the training has been a collaborative effort on the part of ORA, the Center for Drug Evaluation and Research (CDER) — including Ajaz Hussein and key members of the Office of Pharmaceutical Science — other FDA Centers, industry and academia. In addition, it follows on the heels of stepped up training programs for investigators in medical devices and food.

The Pharmaceutical Inspectorate is expected to meet several needs at once:

  • to satisfy congressional and industry demands for a stronger, tighter regulatory process;

  • to enhance integration and collaboration between the Agency’s drug review and evaluation processes, between field offices and the Centers, and between the Agency and industry in general;

  • to help address the current backlog of drug investigations and stay on top of what the Agency deems are the most critical manufacturing facilities needing a watchful eye.
The program is voluntary, and joining the PI is not tied to any promotions or pay increases. Still, FDA is confident that the PI will make a difference. “We want to do this right,” says Susan Setterberg, director of ORA’s central region, who co-chaired the Inspectorate steering committee with Janet Woodcock. “It’s a really great opportunity for the investigators. It puts them right on the cutting edge of what’s going on, so they can do their job better.”

Who are these people?

Whether the training will pay dividends depends upon the caliber of the trainees, who are being kept somewhat of a mystery. “Are they the cream of the crop?” wonders Anisfeld. “Good question.” Eventually, there will be in the neighborhood of 50 inspectors in the PI. According to Setterberg, the 26 in the pipeline right now are some of the most experienced of all drug investigators.

To be considered an entry-level FDA investigator or Consumer Safety Officer (CSO), an employee must have a GS-5 designation, requiring a college degree and at least 30 hours of coursework in the sciences. To qualify for PI training, candidates must have that and at least three years of field experience.

All of the current trainees are well beyond that, Setterberg says. Most have ten to 20 years in the field and are “product specialists” at or near the GS-12 or GS-13 level, so they have already been devoting most of their time to drug inspections. Some are even national experts from the Agency’s Centers in Rockville — namely CDER and CBER — seeking to become part of the Inspectorate. (Even with the PI, FDA will maintain its current staff of field specialists and national experts, as well as Team Biologics, a special corps managed by ORA’s headquarters.)

“We’re not bringing rookies in here,” says Gary German, who oversees all ORA training programs as its director of human resources development. “These people are already good, quality investigators. We’re not teaching them how to be investigators. What we’re talking about is this higher level of information.”
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