The regulatory affairs department is feeling the heat. Pharma management values the function so much that it keeps sending work its way, creating a workload that has increased dramatically over the last decade.
But management may not yet realize what it's done. "The increased volume of global work combined with limited capacity is creating much higher demand for, and pressure on, regulatory affairs professionals," says Ken Getz, senior research fellow at the Tufts Center for the Study of Drug Development.
Getz recently published a study that finds the regulatory affairs function now supports 100 major projects per year, on average; two-thirds are in clinical research phases. He says in an interview that he hopes the study will prompt management to find ways to support the RA team.
That may be easier said than done. The RA function is highly dependent on relationships between pharma RA staff and regulatory authorities, requiring face-to-face and verbal communication, he says. For that reason, he doesn't expect software automation to be much help.
Outsourcing is a candidate, he says. It has already proven itself as a critical way to lower fixed headcount costs in clinical research. "But regulatory affairs is a unique animal, Getz says. "It has defied the outsourcing trend."
Until now, perhaps. If the workload continues to rise rapidly, Getz says outsourcing may become a more viable option.
RA may appear a risky function to outsource. "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."
- here's the Tufts release