HealthSpeak: Coherent Science or Patchwork Quilt?

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December 17, 2007

Coherent Science or Patchwork Quilt?

by Peter Pitts

Okay, so it isn't ALL about the money -- only mostly.

Critical Path Trickles Downstream To FDA Reviewers
The Pink Sheet, December 17, 2007

BY: Daniel Poppy (d.poppy@elsevier.com)

A lack of interest from agency review staff impedes progress of FDA's Critical Path Initiative, industry members observe.

"What I have seen in my own personal interactions, both when I was at the agency and when I left the agency, is there is still a lot of difficulty getting this pushed down to the reviewers," AstraZeneca's FDA Liaison Office Executive Director Cathie Schumaker said at a Critical Path briefing conference.

"I do appreciate much more now that I'm on the industry side how important it is to translate this from a visionary approach to a regulatory approach." Schumaker is the former deputy director of FDA's Office of Information Management.

"There is a disconnect between what we hear at the highest levels and what is happening down in the trenches," said Brian Harvey, who is VP of regulatory policy at Sanofi Aventis and a former director of FDA's Division of Gastroenterology Products.

At CDER, reviewers adhere to established regulatory standards despite being exposed to, and often agreeing with, innovative ideas about drug development, Harvey said.

FDA Office of Medical Policy Director Bob Temple suggested that progress is being made but sees hesitancy from both industry and regulators.

"Anything new takes a little while for everybody to get used to it," he said. "These things are spreading, and I see them in action all the time. That doesn't mean everybody is ready to change the thing they are doing right away. Drug companies are very conservative that way too."

Addressing concerns that CDER's staff is not implementing aspects of the Critical Path Initiative, Janet Woodcock, the center's acting director, stressed the agency lacks resources, not interest.

"We now have very enthusiastic buy-in participation at FDA amongst the reviewers, and that's a big success," Woodcock said at the conference, which was co-sponsored by FDAnews and the Center for Medicine in the Public Interest.

"We have gotten a tremendous number of proposals from scientists at FDA about additional projects that could be done to improve the development process. Unfortunately that would dwarf any and all appropriated funds."

Woodcock acknowledged that the direction of the initiative is still largely contingent upon funding. Although the initiative is now being targeted for appropriations, Critical Path activities generally have been directed by the interests of external parties willing to collaborate with FDA (1"The Pink Sheet" Jan. 22, 2007, p. 29). A recent report issued by FDA's Science Board's Subcommittee on Science and Technology outlined the effect the lack of resources is having on FDA's ability to assess developments in emerging sciences (2"The Pink Sheet" Dec. 10, 2007, p. 15).

Given the ad hoc nature of the projects undertaken, Woodcock suggests that many of FDA's efforts to improve the drug development process will take time to bear fruit. "In 10 years you are going to see a very uneven field where some pieces have advanced and moved forward very rapidly and others may require more work or clinical effort won't have matured, and so you're going to see not a coherent science but a patchwork. And it is still going to be very challenging for everyone, but a lot better than it is now," she said.

"I am trying to take a long-term, transformative view. I don't think you can turn an ocean liner around in a year, especially if it involves scientific research and changes in scientific methods," she added.

Echoing many of the speakers at the conference, Harvey praised Woodcock. "The fact that Janet Woodcock is now back as the acting CDER director is probably the best thing that could ever happen for Critical Path. She has an incredible vision. She really is able to inspire people. ... There is a lot of optimism."

Of course, Woodcock's tenure as CDER director is most likely short lived. FDA has launched a candidate search for a permanent center director so Woodcock can return to her position as FDA deputy commissioner and chief medical officer (3"The Pink Sheet" Dec. 10, 2007, In Brief).

Posted by peterpitts at December 17, 2007 02:09 PM