FDA NEWS: Device Data Collection by Hospitals, Opioid Action Plan Update, Abuse-Deterrent Opioids, Depression Treatment – Drug and Device Digest

FDA BRIEF: week of October 24, 2016


FDA is working with hospitals to modernize data collection about medical devices

By: Jeffrey Shuren, M.D., J.D., Director CDRH
Jeffrey Shuren

Hospital staff use a variety of medical devices, help identify new safety problems with devices,  use technologies in real-world setting of clinical practice

FDA improving work with hospitals to modernize and streamline data collection about medical devices – with focus on SAFETY

(1) Medical device reporting from hospitals

  • Must report device-related serious injuries/ device-related deaths to both FDA and the manufacture
  • However, this is passive surveillance

(2) MedSun (the Medical Product Safety Network) with hospitals

  • Understand and report on device use in the real-world environmen
  • But limited added value, unnecessary costs and resources
  • Not enforced universal reporting requirements

High-profile device safety issues occurring in hospitals in 2015

  • Inspections at 17 hospitals- related to spread of uterine cancer from use of morcellators or  contaminated duodenoscopes

Lessons learned from inspections

  • Didn’t submit required reports for deaths or serious injuries
  • Didn’t not have adequate procedures for reporting device-related death or serious injury events to FDA/manufacturers
  • Need better way to work with hospitals to get the real-world information

Next Steps to effectively work with hospitals

  • Participate in the National Evaluation System for health Technology NEST
  • Asses current reporting requirements
  • Use effective modern tools for surveillance
  • Public workshop to solicit input and advice on improving hospital-based surveillance systems
  • Work with the Association of American Medical Colleges and the American Hospital Association


FDA’s Opioids Action Plan: A Midyear Checkup

By: Robert M. Califf, M.D., FDA Commissioner

Robert Califf

Image result for turn the tide rx

FDA working with Surgeon General’s office (TurnTheTideRx campaign to address Opioid epidemic

Conducted tours of areas hard-hit by the opioid crisis in TN, WV, KY

Opioid education – including training during medical school and residency and greater public awareness far and wide – is a key component in fighting the opioid epidemic

FDA milestones so far include

  • Developing warning and safety information for immediate release opioids
  • Better understand long-term safety of using extended release/long acting opioids
  • Guidance on development of generics with abuse-deterrent formulations
  • Advice from National Academy of Science Engineering and Medicine on balance of patients needs vs. opioid misuse and abuse
  • Supporting increased access to naloxone
  • Launch competition to create Mobile App
  • Approve first implantable treatment for opioid dependence.

FDA will continue work for judicious and responsible use of opioids


Key Facts about “Abuse-Deterrent” Opioids

By: Douglas C. Throckmorton, M.D., Deputy Center Director for Regulatory Programs, CDER

Douglas C. Throckmorton, M.D.

7 approved opioid formulations with abuse-deterrent (AD) properties

  • Tablets/Capsules designed to deter abusers from crushing them into a powder for swallowing, snorting or injecting to create a faster, more intense high.
  • Manufacturers submitted study data demonstrating products are expected to deter abuse.
  • Labeling clearly states the product’s abuse-deterrent properties

“Abuse-deterrent” (AD) vs.abuse-proof

  • AD will always have some potential for abuse
  • FDA requires further post-marketing evaluation of AD products

Generic abuse-deterrent development encouraged


Depression: FDA-Approved Medications May Help
Depression -- FDA Medications Can Help

Treatment with Medication

Antidepressants:  Change neurotransmitters—primarily serotonin, norepinephrine, and dopamine—which are involved in regulating mood.

  • selective serotonin reuptake inhibitors (SSRIs): Prozac (fluoxetine), Celexa (citalopram), Paxil (paroxetine)
  • serotonin norepinephrine reuptake inhibitors (SNRIs): Effexor (venlafaxine), Cymbalta (duloxetine)
  • tricyclic antidepressants (TCAs): Elavil (amitriptyline), Tofranil (imipramine), Pamelor (nortriptyline)
  • monoamine oxidase inhibitors (MAOIs): Nardil (phenelzine) and Parnate (tranylcypromine)
  • Other: Remeron (mirtazapine), Wellbutrin (bupropion)

Antidepressant Effectiveness

  • Regular doses several weeks
  • Significant percentage may not respond to prescribed antidepressant; switching to a different medication or adding another medication can sometimes help treat symptoms
  • Some may not respond to medication

Common side effects

  • Nausea and vomiting
  • Weight gain
  • Diarrhea
  • Sleep disturbances
  • Sexual problems



Scroll to Top