FDA BRIEF: Weeks of November 13 and 20, 2017
CDRH 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
Big 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Two final guidance documents and Two draft guidance documents
- First guidance provides greater clarity around when cell and tissue-based products
- Second final guidance on application of existing regulatory criteria
- First draft guidance, on simplification and streamlining regulatory requirements for devices
- Second draft guidance on expedited programs
FDA 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
Remarks 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
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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