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. For more
information about that proposal, see our story in a prior issue of
the Jones Day's
Pharmaceutical & Medical Device Regulatory
Update.
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