Complex Science

Advancements add yet another challenge for industry's already overextended regulatory body.
Oct 02, 2008


Angie Drakulich
I attended the annual PDA/FDA Regulatory Conference last month to put an ear to the latest Washington buzz regarding harmonization, the theme of this year's meeting. Most of the discussions focused on the newest step taken toward international cooperation—the adoption of ICH Q10: Pharmaceutical Quality System. But there seemed to be an underlying theme to the talks as well.

Both the regulatory speakers and the industry speakers brought up the notion of "increased complexity." But they weren't talking about more complex regulations or supply chains, but rather, more complex science. The idea being that new technologies and advancements in drug delivery, testing, automation systems, and so forth are creating challenges for both drug manufacturers and reviewers.

For example, rapid microbial testing methods and cell-tissue combinations on the biologics side have been especially difficult to review, said Christopher Joneckis, senior advisor for CMC issues at the US Food and Drug Administration's Center for Biologics Evaluation and Research. A "scientific foundation," an "understanding of risk and risk management," and an integration of "product knowledge from multiple sources" are all needed to effectively communicate among individuals of different scientific backgrounds and to regulate properly, he said.

Alyson Saben, deputy director of FDA's Office of Enforcement in the Office of Regulatory Affairs, echoed that thought, adding that FDA needs to have laboratory methods at the same scale as companies to test and validate products properly.

For this reason, the need for continuous training and updating of FDA reviewers and inspectors has greatly increased over the past few years. There's no doubt that the modernization of science is good for pharmaceutical companies and patients, but it's proving to be another challenge for the agency in charge of its oversight. Read more about what was said at this year's PDA/FDA conference at http://blog.pharmtech.com/.

Angie Drakulich is Pharmaceutical Technology's managing editor,