Regulatory Focus™ > News Articles > Woodcock: FDA Time, Resources Now Split Equally Between Premarket, Postmarket Analysis

Woodcock: FDA Time, Resources Now Split Equally Between Premarket, Postmarket Analysis

Posted 23 April 2012 | By Alexander Gaffney, RAC 

Janet Woodcock, Director of the US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER), told a meeting of healthcare journalists the agency is heavily invested in tracking postmarketing regulatory issues and has made significant advancements since 2008, reports Reuters.

"Our oversight of the safety of marketed drugs has changed significantly over the past few years," said Woodcock in a statement. "This report shows that the quality, accountability, and timeliness of postmarket drug safety decisions have been enhanced, and our public communication of this information is more effective."

Woodcock was speaking before the Association of Healthcare Journalists on 21 April, where she also released a new FDA report entitled, Advances in FDA's Safety Program for Marketed Drugs.

Reuters reports Woodcock also noted the agency is now devoting "as much effort and resources on surveilling a drug after it is approved as it does in the pre-approval process."

Since 2008, CDER, which acts as FDA's drug regulatory oversight body, has reportedly:

  • added more than 120 new postmarketing surveillance staff
  • required 65 safety-related labeling changes, mandated 64 "complex" risk evaluation and mitigation strategie
  • ramped up its Mini-Sentinel adverse event tracking project to more than 125 million patients
  • established a new Office of Biostatistics to focus on postmarket drug safety.

"We think we've really balanced this," remarked Woodcock, referencing the agency's efforts.

"Moving forward, all of our safety efforts, while they will remain thorough, systematic, and scientific, will continue to be designed to support our parallel efforts to advance innovation and to help ensure that safe and effective new therapies are available to the American public as efficiently as possible," concluded FDA in its report.

Read more:

Reuters - FDA says focused on tracking drugs after approval

FDA - Press Release: Report: FDA strengthens monitoring of post-approval drug safety 

FDA - Advances in FDAs Safety Program for Marketed Drugs

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