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Advancing Regulatory Science for Medical Countermeasure Development Workshop Summary (2011) / Chapter Skim
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4 MCM Regulatory Science Needs for At-Risk Populations
Pages 65-70

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From page 65...
... In regular pediatric medical care, 50 to 75 percent of pediatric medications are used off-label. This lack of approved pediatric labeling for certain indications significantly affects federal jurisdiction and deployment of MCMs in the SNS, Siegel pointed out.
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From page 66...
... Moving forward, Siegel supported efforts to establish an obstetrics/ pediatrics section or working group at BARDA to examine the current contents of the SNS, be aware of up and coming MCMs, be part of the MCM prioritization process, and make obstetric/pediatric study recom mendations for the necessary PK, efficacy, and safety data. FDA, he said, should be actively involved in this section, working proactively with aca demia and industry sponsors to expedite MCM development.
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From page 67...
... Increased volume of distribution, altered protein binding, increased glomerular filtration rate, and other maternal changes complicate dosing determinations. From a more societal perspective, Macedonia pointed out that pharmaceuticals and vaccines are generally not tested in pregnant human patients.
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From page 68...
... In discussion, Pravin Jadhav of FDA's CDER explained that FDA has a pediatric decision tree to guide decisions regarding what kind of data, and how much, is needed to approve a drug for pediatric use. There would be no difference, he said, between how the agency would handle drugs for pediatric MCM use compared to any other pediatric drug (although he acknowledged that MCM development may rely more on data from animals, as well as PK and systems biology data)
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From page 69...
... Lisa Mathis of CDER noted that due to the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act, among other devel opments, nearly 50 percent of products are now labeled for pediatric use, up from 25 percent. Unfortunately, she noted, there has not been that same level of advocacy in support of pregnant and lactating women.
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From page 70...
... Nelson added that although FDA does not have regulations governing research involving pregnant women, HHS human research regulations (45 CFR 46, Subpart B) provide for additional protections for preg nant women and fetuses.
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Key Terms

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  • regulatory science
  • direct benefit
  • pediatric research
  • additional protections

  • animal studies
  • research equity
  • children act
  • therapeutic agents
  • decisions based

  • equity act
  • game theory
  • safety data
  • human research
  • pediatric medications

  • regarding children
  • pediatric decision
  • children ate
  • derive pediatric
  • regular pediatric

  • mcm regulatory
  • research involving
  • pregnant woman
  • hhs human
  • pediatric label

  • pediatric medical
  • regulatory issues
  • involving pregnant
  • ing research
  • pediatric labeling


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