cGMPs / Facilty Design & Management

Woodcock: Show Us the Money — and the Science

The next few years won’t be easy, FDA’s deputy commissioner for operations predicts. Manufacturers will need to change their cultures from within, she says.

By Paul Thomas, Managing Editor

Janet Woodcock, M.D., FDA’s deputy commissioner for operations, detailed the status of the Agency’s Critical Path initiative at the recent ISPE Annual Meeting in Phoenix. Since it was introduced early in 2004, the Critical Path has brought a renewed emphasis upon scientific practices and investments beyond the R&D arena, something that been lacking within the industry.

“We’ve always put a huge amount of money and brainpower into R&D,” Woodcock notes, “but we haven’t put the same emphasis on the process of bringing medications to the public.” This has hampered the industry’s progress and FDA’s efforts to develop “enabling standards.” “Our standards are only as good as the science that they are derived from,” she stresses.

Adding to the industry’s woes has been the fact that academic research in pharmaceutical science has not been well-funded, and that the industry has kept the technical aspects underlying its products and processes under a proprietary lock and key.

What FDA has learned since embarking upon the Critical Path initiative, Woodcock says, is that:
  • There has not been an adequate funding source for much-needed research in pharmaceutical development and manufacturing.

  • The industry still has serious concerns about intellectual property;

  • There are no good business models available for optimizing the Critical Path;

  • There are insufficient academic rewards for pursuing cutting-edge research;

  • There is a lack of trained, interdisciplinary personnel within the industry.
The seeds of change will come from manufacturers, who will need to collaborate, develop consortia, and make a practice of sharing what Woodcock calls “precompetitive knowledge” about manufacturing.

The Critical Path’s next step, says Woodcock, is implementation, which will require a significant cultural shift on the part of manufacturers, who will need to trust FDA and their manufacturing counterparts — not easy changes to make. “The next few years will be trying for all of us,” Woodcock says, “but we really don’t have any choice.”

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