Report finds ORA a different animal from rest of agency

The FDA's Office of Regulatory Affairs is a different animal from the rest of the regulatory agency and so faces different issues when it comes to finding and keeping talent, a new report says.

In general, the just released 8-chapter review says the FDA is making strides at expanding and improving its workforce to meet the critical role it plays in keeping industry compliant and consumers safe. The report follows up on a critical assessment given the FDA's workplace in 2007. As Pharmalot reports, issues persist. It takes too long to make hires and relies too heavily on temporary employees. The FDA doesn't do a great job of training staffers when it gets them onboard and needs to work on recruiting and leadership development. Oh, and the work can be overwhelming.

The report looks at the 5 key FDA centers, one of those being ORA, whose inspectors are known to all those running Big Pharma's manufacturing plants. The report says it found "marked differences between ORA and the other FDA centers" when it comes to average salaries, which are lower; average tenure, which is longer; and geographic distribution, which is all over the place, so to speak. More than 85 percent of ORA's 3,775 employees work in 5 regional offices, 20 district offices, 13 laboratories, and more than 150 resident posts and border stations, the report points out. FDA maintains offices and staff in Washington, DC; the U.S. Virgin Islands; Puerto Rico; and in all U.S. states except Wyoming. The agency also has new funding that will expand its overseas inspections.

While the other centers have lots of scientists and doctors making the bigger bucks, ORA has a much smaller percentage of its workforce making above $100,000, the report says. The dispersion makes for some challenges in coordination and having to hire into different locations. Despite those possible obstacles to getting and keeping employees, ORA has a higher percentage of employees who have been at the agency 20 to 30 years and of employees with more than 30 years federal employment. That said, its average age, at 44 years, is lower than the other centers. Only 4% of its workforce is temporary, compared with 36% to 55% at the other four centers.

- here's the FDA report (pdf)
- read what Pharmalot has to say