Putney says the FDA girl has got to have soul!

  • by: |
  • 06/23/2010

Pursuant to yesterday's discussion of the HHS IG's report on FDA's oversight of non-US based clinical trials, some commentary from Leslie Ball, director, division of scientific investigations, Office of Compliance, FDA Center for Drug Evaluation and Research:

"As a consequence of that report, I think we will be looking, internally, at the quality of data a little bit more critically that's conducted outside the U.S. ...
That might result in some additional analysis and soul-searching about whether or not requirements need to be put in place."

A new site-selection model already is under development that will move the agency to a more risk-based approach to determine which sponsors will be inspected, Ball said.

The factors that could trigger an inspection include the drug application and trial design, or site-specific risk attributes like enrollment and drop-out rate. FDA Principal Deputy Commissioner Joshua Sharfstein said in his response to the report geography also is a risk parameter in the formula.

"We are expecting that to be a little more complex," she said. "We also want to say that just when the regulated community figures out what our risk algorithm is, we will change it. So don't get too comfortable."

FDA also already is looking to expand its partnerships with other regulators, as was recommended in the report to maximize its resources. A pilot program with the European Medicines Agency to conduct joint inspections and share other information, if successful, could lead to more collaborations with other foreign regulators.

CMPI

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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