FDA News: Commissioner Remarks, Supply Chain Security Toolkit, Measuring Cancer Patient Benefit, Fighting Misleading Ads – Drug and Device Digest

FDA BRIEF: Week of May 29, 2017

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FDA Commissioner Remarks to the 2017 FDA Science Forum

FDA’s work environment encourages creativity, efficiency, and superior science

  • Address challenges  in promoting and protecting the public health
  • Ability to use tools of science to meet public health challenges

Volume and complexity of regulated products increasing

  • More novel drugs and medical devices
  • New technologies such as gene therapy, gene editing, regenerative medicine

Broader societal challenges

  • Addiction to opioids and the abuse of opioid drugs, tobacco products
  • Address health care costs without sacrificing medical innovation

Science at FDA

  • CDRH developing novel methods to create models of virtual patient outcomes
  • Massive longitudinal study on Population Assessment of Tobacco and Health
  • Progress in nanotechnology, 3D printing, computational modeling and simulation
  • GenomeTrakr network
  • Human organ systems in miniature, micro-engineered chips to evaluate toxicity


drug supply chain

FDA Leads Effort to Create a Supply Chain Security Toolkit for Medical Products

Medical Product Security Toolkit covers entire supply chain and lifecycle- from raw materials to use by patients

  • Developed in collaboration with Asia Pacific Economic Cooperation (APEC)
  • Processes, procedures, and tools to enhance quality and supply chain security
  • Help support global sourcing and manufacturing of medical products

Addresses areas of vulnerability in the medical product supply chain

  • Prevent, detect substandard/falsified medical products prior to reaching consumer
  • Respond to incidents
  • Tools and training for 10 categories covering supply chain


Rick Pazdur

In cancer treatment, there’s more than one way to measure patient benefit

By: Richard Pazdur, M.D., Director, Oncology Center of Excellence

Randomized controlled study demonstrating improvement in overall survival (OS) is gold standard for new cancer therapies 

Not viable for:

  • Slow growing tumors
  • Targeting specific mutations
  • Comparison with standard therapy with modest benefit (loss of equipoise)

Alternative endpoints:

  • Progression-free survival (PFS)
  • Overall response rate (ORR)
  • Supported by patient and advisory committee feedback
  • Several approvals – renal cell carcinoma, Merkel cell carcinoma, medullary thyroid cancer, gastrointestinal stromal tumor, metastatic basal cell carcinoma, pancreatic neuroendocrine tumor, multiple myeloma, chronic myelogenous leukemia, chronic lymphocytic leukemia, certain types of lung cancer

Approval based on meaningful difference for patients and their loved ones:

  • Incorporate patient’s experience and quality of life in benefit-risk assessments
  • Evaluate post-approval real-world use; inform labeling


#IAmHHS: Fighting Misleading Prescription Drug Ad Claims

  • Develop policies for advertising and promotion of prescription drugs
  • Truthful and not misleading
  • Ensure pharmaceutical industry understand the rules of the road


Image credits: FDA



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