FDA Views on 2017 Budget, Interoperability, Proprietary Names, Biomarkers – Drug and Device Digest

FDA Brief: Week of Feb 8, 2016



FDA Voice


FDA seeks $5.1 billion total for FY 2017, including funds to implement food safety law, improve medical product safety and quality

  • Total budget of $5.1 billion to protect and promote the public health
  •  Several key areas related to Drug and Medical Devices
  • Improving the Safety and Quality of Medical Products
    • Precision medicine tools to “personalize” the diagnosis and treatment
    • Safety of compounded drugs through inspection and enforcement activities
    • Policies for antimicrobial drug use in animals to protect antibiotic effectiveness
    • Prevent prescription opioid abuse, speeding generic drug access, reducing drug shortages.
  • Supporting the National Cancer Moonshot Initiative
    • Oncology Center of Excellence with regulatory scientists and reviewers
    •  Integrated approach for prevention, screening, diagnosis, and treatment
    • Companion diagnostic tests
    • Combinations of drugs, biologics and devices
    • Precision Medicine science.
  • Investing in the FDA’s Infrastructure


Building a case for medical device interoperability: FDA’s Call to Action

by Bakul Patel, M.S., M.B.A., is associate director for digital health in FDA’s Center for Devices and Radiological Health

  • Interoperability : Smart and safe interaction among medical devices and information systems
  • Medical Device Interoperability: Improve patient care, reduce errors and adverse events, lower costs. Critical safety factor
  • FDA collaborating with stakeholders (e.g. hospitals, health care providers, manufacturers, standards-development organizations) to promote medical device interoperability to help patients
  • Key Activities:
    • Summit on Medical Device Interoperability (2012)
    • Manufacturing standards (2013)
    • Finalize Guidance on medical device data systems-MDDS ( 2015)
    • Draft Guidance on Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices (2016)


Working to prevent proprietary drug name confusion

by Lubna Merchant, M.S., Pharm.D., Deputy Director, DMEPA,  

About medication errors: Preventable event leading to inappropriate medication use or patient harm

Drug name confusion can cause medication errors : Shared strength or dose between products, drugs with similar names, confirmation bias (tendency to search for, interpret, or recall information in a way that confirms one’s beliefs or hypotheses)

Efforts to avoid drug name confusion before approval: Safety review,  look for error-prone naming attributes (spelling, pronunciation, appearance), prescription simulation studies, use FDA’s Phonetic and Orthographic Computer Analysis (POCA) program to identify similar looking or sounding names, analyze using failure modes and effects analysis (FMEA) for failures

Reporting medication errors to FDA: Evaluate reports from companies, health care professionals, patients and other sources (e.g Institute for Safe Medication Practices). Apply  “lessons learned” to improve drug name review process

Addressing name confusion errors and informing the public: Drug safety communications, consumer updates, or scientific literature

Help combat drug name confusion errors: Build awareness amongst health care professionals, pharmacists, nurses, patients

Draft Guidance (2015):  “Best Practices in Developing Proprietary Names for Drugs.”


Clarifying What We Mean When We Talk About Biomarkers: An NIH/FDA Joint Leadership Council Success

by Melissa A. Robb, B.S.N., M.S. (RegSci), is FDA’s Associate Director for Regulatory Affairs, Office of Medical Policy, CDER Robert M. Califf, M.D., is FDA’s Deputy Commissioner for Medical Products and Tobacco

  • Biomarkers, Endpoints, and other Tools (BEST) Resource : FDA + NIH collaboration
  • Harmonizing definitions and use of key terms e.g. biomarkers, surrogates, clinical outcome assessments
  • Requesting public feedback on glossary BEST (Biomarkers, EndpointS, and other Tools) Resource.





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