Regulatory Affairs Workload Increasing

I would rather have a big burden and a strong back, than a weak back and a caddy to carry life’s luggage

– Elbert Hubbard

I don’t know if you follow the Tufts Center for the Study of Drug Development (CSDD), but they’re always full of good information and analysis of drug development issues.  If you ever read of their reports, I guarantee that you’ll learn something.

In their March/April Impact report, the CSDD said one of their studies concluded that the “regulatory affairs workload at drug development firms has increased dramatically” in recent years.  This study was, in their own words, the “first systematic assessment of global regulatory affairs performance”.  (Regulatory affairs?  Hey, that’s me!)

Lead by CSDD Senior Research Fellow Ken Getz, the study focused on regulatory affairs groups in mid-sized to large, global drug/biologic companies.  In addition to the increase in overall workload, the study also found:

• Regulatory affairs functions support, on average, 100 major projects per year, two-thirds of which are in clinical research phases.
• On average, 39% of regulatory staff has more than 10 years of experience. This compares to 9% for clinical staff.
• Annual average internal staff turnover for regulatory affairs groups was 6.5%, compared to 21% for clinical groups.
• Companies report that only 5% of staff are contract employees, who are engaged most frequently in connection with dossier compilation.

All of this certainly jibes with our experience, but will an increase in internal regulatory affairs workload lead to a commensurate increase in outsourcing?  Historically, regulatory outsourcing has lagged behind clinical outsourcing.  However can that trend continue if regulatory workload keeps increasing?

Fierce quoted an interview with Getz on this topic:

“But we heard the same thing about clinical trials a decade ago,” he says. So too for protocol design and NDA preparation. “All were considered more strategic,” Getz says. “But some companies pioneered CROs in that direction.”

Pioneered indeed.  At the risk of introducing my own notions between the lines, we have also observed that some regulatory departments are feeling overworked and under-resourced.  More and more, they are willing to outsource projects that used to be kept close to the chest.  For example, we are seeing an increase in requests for strategic insourcing (an intermediate to full-regulatory-project outsourcing) to help alleviate the pressure that active regulatory affairs groups are experiencing.