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Legislators and Groups Urge FDA to Require Sex-Specific Data, Labeling in New Action Plan




by:
Laurie A. Clarke
Colleen Heisey
Mark Mansour
Christopher M. Mikson
Emily K. Strunk
Jones Day - Washington Office

 
August 5, 2014

Previously published on July 2014

Members of Congress and interest groups are pressuring FDA to promote sex-specific clinical research and product labeling, as the Agency develops an action plan to address deficiencies in the way industry collects, analyzes, and communicates demographic data.

Fulfilling a requirement of the Food and Drug Administration Safety and Innovation Act of 2012 ("FDASIA"), FDA studied the extent to which demographic subgroups (sex, race, and ethnicity) participate in clinical trials and how this information is used and disclosed. The Agency delivered a summary report to Congress in August 2013. Testifying before the House Energy and Commerce Committee earlier this month, Center for Drug Evaluation and Research ("CDER") Director Janet Woodcock said FDA will soon issue an action plan based on those findings. In response to questions about the "sex gap" in drug and device research, Woodcock indicated the Agency is making efforts to ensure females are equally represented in clinical trials. Interest groups, such as the National Women's Health Network, have been pressuring the Agency to set standards to ensure adequate clinical participation so that safety and effectiveness data can be analyzed based on sex, race, and ethnicity. The American Medical Association also has encouraged sex-specific disclosures (such as modified dosage recommendations) in product advertisements to physicians.

Meanwhile, the National Institutes of Health is developing its own rules for preclinical research grant proposals, which would mandate the inclusion of both male and female animals or tissues.



 

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Laurie A. Clarke
Colleen Heisey
Mark Mansour
Christopher M. Mikson
 
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