FDA News: Consumer Expenditure, Impetigo Treatment, Post-Marketing Commitments, National Cyber Security Awareness Month – Drug and Device Digest

FDA BRIEF: Week of October 31, 2016


Consumer expenditure on FDA regulated products: 20 cents of every dollar

By: Sheri Walker, Ph.D., FDA Senior Economist, and Clark Nardinelli FDA Chief Economist

20 cents pie chart

FDA-regulated products account for about 20 cents of every dollar of annual spending by U.S. consumers.

  • > $2.4 trillion in annual consumption (medical products, food, tobacco)
  • Based on expenditure data collected by the Bureau of Economic Analysis (BEA)


impetigo and kids

How to Treat Impetigo and Control This Common Skin Infection


  • Staphylococcus aureus and Streptococcus pyogenes, bacteris found on skin
  • > 3 million cases in US every year
  • Prevalent in kids 2 – 6 years old: itchy red sores, itchy rash, fluid-filled blisters


  • Presription topical or oral antibiotics
  • NO over-the-counter (OTC) treatment


Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements (PMRs) and Postmarketing Commitments (PMCs) (FY 2013 and FY 2014)


Postmarketing requirement (PMR): Drug study equired by statute or regulation to conduct after drug approval

Postmarketing commitment (PMC): Agreed post-approval study but not required by statute or regulation.

  • To assess a known serious risk or identify an unexpected serious risk
  • Study certain new drugs for pediatric populations
  • Verify and describe the predicted effect for accelerated approval
  • For approval on animal efficacy because human trials not ethical or feasible

CDER’s 2013-2014 Evaluation of PMRs & PMC Data

  • Similar  number of applicants and unique applications with PMRs/PMCs: more with drugs than biologics
  • Most applicants meeting annual reporting obligation
  • >50% PMRs for pediatric research
  • Majority of PMRs/PMCs progressing on schedule
  • Comparatively fewer PMRs/PMCs off schedule


National Cyber Security Awareness Month: Understanding the Interdependencies of Medical Devices and Cybersecurity

By: Suzanne B. Schwartz, M.D., M.B.A., Associate Director for Science and Strategic Partnerships, CDRH
Suzanne Schwartz

FDA guidances for monitoring, identifying, and addressing pre- and post-approval cybersecurity vulnerabilities in medical devices

  • Life cycle approach to cybersecurity risk management – from early product development and extending throughout product’s lifespan
  • Collaborating with entities that discover threats or vulnerabilities
  • Developing appropriate solutions prior to vulnerabilities being publicly disclosed

FDA partnership with the National Health Information Sharing and Analysis Center (NH-ISAC), and the Medical Device Innovation, Safety, and Security Consortium (MDISS)

  • Rapid sharing of medical device vulnerabilities, threats, and mitigations within the hospital and health care ecosystem



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