FDA BRIEF: Weeks of November 13 and 20, 2017


CaptureCDRH Approach to Tumor Profiling Next Generation Sequencing (NGS) Tests

Marketing authorization of two tumor profiling NGS tests

  • Thermo Fisher Scientific’s Oncomine Dx Target Test1 and MSK-IMPACT2
  • Real-world application of precision oncology

Three-Tiered approach for reporting biomarkers

  • Level 1: Companion Diagnostics
  • New Level 2: Cancer Mutations with Evidence of Clinical Significance
  • Level 3: Cancer Mutations with Potential Clinical Significance
  • A Fluid Approach to Reporting within Levels 2 and 3

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Capture.JPGBig Day for Regenerative Therapy

Comprehensive policy framework for development and oversight of regenerative medicine products, including novel cellular therapies

  • Builds upon the FDA’s existing risk-based regulatory approach
  • Proposes efficient, science-based process to ensure safety and effectiveness
  • Risk-based framework for enforcement actions against significant safety concerns

Two final guidance documents and Two draft guidance documents

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CaptureFDA Workforce and Diversity Plan

FDA challenged with building and retaining diverse, talented, dedicated workforce

  • Building stronger workforce by key process improvements in hiring and retention
  • Congress authorized new resources and authorities for talented workforce

FDA Hiring Initiative

  • Comprehensive evaluation of our hiring practices and procedures
  • Assess current challenges and provide roadmap for future
  • Initial Assessment of FDA Hiring and Retention report
  • Hiring pilot to modernize and streamline hiring practices; use new IT tools and eliminating unnecessary processes
  • Digital and social media tools for modern recruitment and outreach techniques

FDA Diversity and Inclusion Strategic Plan

  • Cultivate and promote diverse, inclusive culture
  • Promote continuous learning and discussion of diversity and inclusion topics
  • Recruit qualified candidates of different backgrounds, experiences, talents
  • Leverage every individual’s perspectives, passions, and background;  positive
    impact on innovation

WORKFORCE

DIVERSITY


Capture.JPGRemarks by Commissioner Gottlieb at FDA Office of Criminal Investigation Meeting

 Office of Criminal Investigations’s (OCI) nationwide presence

  • To advance FDA’s criminal law enforcement operations
  • To address criminal wrongdoing involving FDA-regulated products
  • Key to stopping dangerous counterfeit, unapproved, misbranded medical products into domestic supply chain

Comprehensive approach to President’s declaration of opioid crisis a public health emergency

  • Issuing guidance to encourage development of therapies to treat opioid addiction
  • Encouraging widespread use of existing, safe, effective FDA approved therapies to help combat addiction
  • Requirement for opioid manufacturers make training available to prescribers, potentially making them mandatory
  • Guidances to develop abuse deterrent opioids and non-addictive alternatives in the treatment of pain
  • Careful balancing of risks and benefits  when making approval decisions or market withdrawals

Dealing with bad actors that see addiction as an opportunity for profit

  • Using regulatory authorities and pursuing criminal charges
  • Will require manufacturers to  follow FDA market withdrawal notices e.g. Endo
  • Aggressive steps to identify and disrupt affirmative misconduct
  • Criminal enforcement actions in recent months e.g. Insys
  • Build cases against individuals who tamper with opioids at pharmacies, hospitals
  • Taking further action relating to a botanical substance known as kratom due to risks of abuse, addiction, and death
  • Increasing OCI’s Cybercrime Investigations Unit, Strategic Intelligence Unit, and Intelligence Analysis Branch

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Steps to promote development of generic versions of opioids formulated to deter abuse

Opioids with abuse-deterrent formulations (ADFs) intended to make abuse, such as crushing, snorting, dissolving, more difficult or less rewarding

  • Approved 10 opioid drugs with these properties
  • But low uptake- learning curve, low awareness,prescribing uncertainty, price

FDA plans to permanently transition older formulations to ADFs

  • Improve access to the newer formulations through generic competitors
  • Final guidance on development of generic versions of approved ADF opioids
  • Developing appropriate, improved testing methodologies for evaluating abuse deterrence for both brand name  and generic opioid drug products
  • Flexible, adaptive approach to the evaluation and labeling of ADF opioids
  • Determining effectiveness of ADF products  in  real-world setting
  • Better understanding the attitudes and beliefs of health care professionals and those who are prescribed these products

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Image credit: FDA

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