FDA news: Right to Try Act, Shared System REMS, Innovation Challenge for Devices targeting Abuse, Software Functions excluded as Devices, Liver Toxicity Understanding, Sunscreen Effectiveness – Drug and Device Digest


Statement from FDA Commissioner Scott Gottlieb, M.D., on the signing of the Right to Try Act

May 30th: President signed into law the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 (Right to Try Act)

  • FDA to implement legislation to promote access and protect patients
  • Patients facing terminal conditions have an additional avenue to access promising investigational medicines
  • Will build on FDA’s exisiting Expanded Access program that enhances access to promising investigational medicines for those unable to access products through clinical trials
  • Will recognize the important balance between making sure patients have the assurances Congress intends, while enabling timely access to promising treatments in these devastating circumstances



New policies to reduce the ability of brand drug makers to use REMS programs as a way to block timely generic drug entry

Risk Evaluation and Mitigation Strategy (REMS) requirements have been exploited to block timely generic entry

  • At the front end of the drug development process- Restrict availability of branded drugs needed to run bioequivalence studies for generic drugs
  • At the back end of the process for drug approval and marketing – Delayed agreements for generics to enter branded drug Shared System REMS

New policy to help generic drug makers maintain safety controls sought by REMS



As part of efforts to combat opioid crisis, FDA launches innovation challenge to spur development of medical devices ‒ including digital health and diagnostics ‒ that target pain, addiction and diversion

FDA working to address opioid crisis and support goals of  U.S. Department of Health and Human Services’ Five-Point Strategy to Combat the Opioid Crisis

  • Significant focus on decreasing exposure to opioids and preventing new addiction
  • Supporting treatment of those with opioid use disorder
  • Fostering development of novel pain treatment therapies and opioids more resistant to abuse and misuse
  • Taking action against those who contribute to the illegal importation and sale of opioid products

Innovation challenge to encourage medical product developers to submit proposals

  • Diagnostics to identify patients at increased risk for addiction
  • Treatments for pain that eliminate the need for opioid analgesics
  • Treatments for opioid use disorder or symptoms of opioid withdrawal
  • Devices or technologies that can prevent diversion of prescription opioids
  • Devices with improved benefit-risk profile vs.  opioids in pain management

Benefits for accepted proposals

  • Enhanced interactions with FDA review divisions during development and evaluation
  • Breakthrough Device designation granted

Deadline: June 1 – Sept. 30, 2018


Capture.JPGFDA seeking comments on risks and benefits to health associated with software functions excluded from the device definition by the Cures Act

Per the Cures Act, certain medical software functions are not medical devices

  • for administrative support of a health care facility
  • for maintaining or encouraging a healthy lifestyle
  • to serve as electronic patient records
  • for transferring, storing, converting formats, or displaying data
  • to provide limited clinical decision support

FDA requesting input on risks and benefits  with these non-device software functions

  • From all interested parties, including patients, consumers, healthcare providers, startup companies, health plans or other third-party payers, venture capital investors, information technology vendors, health information technology vendors, small business purchasers, employers, and other stakeholders
  • FDA will incorporate input to develop report on risks and benefits of these software functions

submit your comments

Capture.JPGNCTR… Improving Understanding of Liver Toxicity

  • Role of Cytochromes in Dronedarone-Induced Liver Toxicity
  • Therapeutic Bile Acids and the Risks for Liver Toxicity
  • Monograph Published on Drug-Induced Liver Toxicity
  • Early and Sensitive Biomarkers of Liver Toxicity Discovered



New FDA actions to keep consumers safe from the harmful effects of sun exposure, and ensure the long-term safety and benefits of sunscreens

Most cases of melanoma can be attributed to cumulative UV exposure

  • Policy efforts to promote innovation in sunscreen (Sunscreen Innovation Act)
  • Help promote product innovation when it comes to better sunscreens

New efforts to advance framework for sun protection products

  • Making sure that products deliver advertised benefits
  • Warning letters to companies illegally marketing pills and capsules labeled as dietary supplements with unproven claims about protection from sun exposure harm
  • Encouraging industry to conduct research on additional sunscreen active ingredients to enhance safety
  • New FDA process to review the safety and effectiveness of sunscreen active ingredients
  • New draft guidance regarding Maximal Usage Trials (MUsT) for topically-applied active ingredients



Image credits: Congress, FDA

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