FDA News and Views: Addressing Opioid Epidemic, NASEM Report on Opioid Abuse, Precision Medicine Approvals, Clinical Trials in India, Class II Device Exemptions – Drug and Device Digest

FDA BRIEF: Week of July 10, 2017

 Marshaling FDA Benefit-Risk Expertise to Address the Current Opioid Abuse Epidemic

By: Scott Gottlieb, MD, Commissioner & Janet Woodcock, MD, Director, CDER

Addressing the opioid crisis is a national priority and role of prescription opioids is critical FDA focus 

  • Need to consider both benefits of opioids for severe and chronic pain, as well as the multiple adverse effects
  • FDA assesses diverse risks and benefits to ensure that it is considering the full public health implications of any decisions
  • Sought market withdrawal of Opana ER over concerns about illicit use
  • Placed specific restrictions on certain prescription fentanyl formulations to prevent life-threatening respiratory depression
  • Placed limits on prescribing of sodium oxybate to prevent abuse
  • Continuing efforts to support development of abuse-deterrent opioids
  • Commissioned study from National Academies of Sciences, Engineering, and Medicine (NASEM) to identify additional actions FDA should consider to address opioid crisis


 National Academies of Sciences, Engineering, and Medicine (NASEM) report on pain management and prescription opioid abuse

By Scott Gottlieb, MD, Commissioner

NASEM Report on prescription opioid abuse, misuse and pain management
  • Opioid approval and removal decisions made within a benefit-risk framework evaluating outcomes when used as prescribed as well as public health effects of inappropriate use
  • Reducing rate of new addictions by ensuring only appropriately indicated patients are prescribed, for durations and doses matching clinical reason
  • Securing the critical data needed to better understand the impact of opioid medications

 Will require coordinated effort including federal, state, and local partners to properly address its continued destruction of individual lives and families


Two Recent Scientific Advances Underscore an Encouraging Future for Precision Medicine at FDA

By: Janet Woodcock, MD, Director, CDER

Two recent FDA drug approvals point to an encouraging future for “precision medicine”

  • Involve diseases resulting from particular genetic characteristics identified by laboratory testing
  • KALYDECO (ivacaftor) indicated for 33 Cystic Fibrosis  mutations
  • KEYTRUDA (pembrolizumab) to treat cancers having specific genetic feature (instead of location)

FDA has also approved “targeted therapies”

  • 25 new drugs that benefit patients with specific genetic characteristics
  • New uses for marketed drugs based on specific genetic characteristics e.g. rare genetic disorders


Leslie Ball, M.D., FDA Assistant Commissioner of International Programs and Elizabeth Wiley, M.D., J.D., M.P.H., AAAS Science and Technology Policy Fellow

FDA Collaborates to Promote Safety, Quality in Clinical Trials Done in India

 By: Leslie Ball, MD, Assistant Commissioner for International Programs, Letitia Robinson, PhD, RN, FDA India Office, Elizabeth Wiley, MD, JD, MPH, Office for International Programs

India holds vast potential for clinical research and has become a global leader in generic drugs

  • FDA’s Office of International Programs (OIP) and India Foreign Office adopted strategic engagement approach- inspections, targeted engagements, training, collection and use of data- to inform FDA decision-making

Joint training workshop for Indian regulators, academic representatives, and drug industry on scientific and ethical standards for clinical trials

  • Identifying general concepts in inspections of clinical investigators, clinical trial sites, ethics committees, and bioanalytical study sites
  • Identifying techniques for maintaining data integrity in clinical trials
  • Reviewing inspections to develop evidence and determining appropriate observations to include in inspection reports

Effort to promote data integrity, credible and accurate results, and protection of subjects in clinical trials


Class II Device Exemptions from Premarket Notification 

Federal Register announced 1,003 class II exempt device types sufficiently well understood and do not present risks

  • To decrease regulatory burden
  • To reduce private costs and expenditures
  • Follows streamlined procedures established by the 21st Century Cures Act
  • Some device types are partially exempt from premarket requirements
  • New product codes issued


Image credit: FDA




Scroll to Top