FDA Aims To Rebuild Its Science Reputation, Plans New Projects

Seven priority areas include rapid detection of contaminants, adverse event detection and analysis, biomarkers, and clinical trial design and analysis.

FDA is embarking on a series of projects this year to address key scientific questions and, in the process, help rebuild the agency's suffering reputation.

Chief Scientist and Acting Commissioner Frank Torti is at the helm of the effort. At a Feb. 24 FDA Science Board, he presented a report outlining the projects and other initiatives for strengthening regulatory science and improving the agency's recruitment practices.

The new report addresses criticisms lodged in a November 2007 Science Board report and two prior Institute of Medicine reports (¹ (Also see "FDA Scientific Capacity Inadequate; New Device Technology At Risk" - Medtech Insight, 10 Dec, 2007.), p. 5). Torti suggested such progress reports from the Office of Chief Scientist could become annual events.

Last fall, Torti started to meet with the directors of FDA's product centers to come up with FDA scientific priorities targeting, in particular, areas where science and regulatory functions overlap.

"We asked each director, what are the key scientific pieces that you need to attack to improve the regulation of the products you manage in your center?" he explained in an interview.

Among the seven priority areas are rapid detection of contaminants, adverse event detection and analysis, biomarkers, and clinical trial design and analysis.

Each FDA center identified specific projects that fall within one of the priority areas. Now they are tasked with coming up with deliverables, budgets and timetables for each.

"These kinds of projects cannot be tackled on a year-to-year or one-year basis," Torti said at the science board meeting in Gaithersburg, Md. "A good scientific project of the dimension that we're asking for is going to have to spread over a number of years."

Four projects are planned by CDRH. The center created rapid detection projects to assure the safety of ophthalmic medical devices and to develop new approaches to analyzing chemical contamination on device surfaces.

CDRH also plans to conduct a biomarkers project on computational endpoints for cardiovascular device evaluations and a clinical trial design project on improving imaging device trials.

An ad hoc Science Board subcommittee chaired by David Parkinson, president and CEO of biotech firm Nodality, will review each center's projects and report back to the full committee in the spring. Funding for some of the projects began in January, but FDA awaits Science Board sign-off prior to full implementation.

Genomics, combination products gurus

FDA also needs to better anticipate future scientific regulatory needs and to build a cadre of "cutting edge" scientific professionals, Torti's report acknowledges.

Among several initiatives, FDA is coordinating its genomics research, and on Feb. 1 named Liz Mansfield to the new position of senior genomics advisor in the Office of the Chief Scientist (² (Also see "People In Brief" - Medtech Insight, 23 Feb, 2009.), p. 19). The chief scientist office has also tapped someone to focus on regenerative medicine combination product issues, which "represent a unique challenge for FDA regulation," the report says.

Further, Torti's office intends to launch a new scientific journal, provisionally titled the Journal of Regulatory Science, which will publish articles relevant to FDA regulatory science. The journal should be up and running and an editor-in-chief named by July, he said.

Each of the new science priorities has been coordinated with FDA's fiscal 2009 budget allowance as well as next year's budget formulation, the science report says.

"I think [we are at] a turning point," Torti told the Science Board members. "We have a president who has identified science as a major initiative. That's very exciting and very exciting to the folks at the FDA, and with that I am sure will come some additional resources to do that."

Events suggest Torti is correct. Congress is moving on a fiscal year 2009 appropriations package that proposes a big increase for FDA. President Obama's 2010 budget request is also slated to include significant new money for the agency.

But Torti acknowledges that the steps outlined in his report are just the tip of the iceberg.

"This is a problem that is going to take multiple years of hiring, that is going to take multiple years of scientific development, that is going to take some pilot projects and some strategy," Torti told staffers at an internal FDA meeting earlier in February.

-Jessica Bylander ([email protected])

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