FDA News and Views: SUPPORT Law for Substance Use Disorder, Global Crackdown on Illegal Drug Websites, ClinicalTrials.gov Civil Money Penalties, Standing with Pittsburgh’s Jewish Community – Drug and Device Digest


Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act

President signed into law the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act

  • Require certain opioid packaging for shorter durations of use,  reduce number of 30-day prescriptions, address problem of excess supply
  • Require opioids be dispensed with mail-back pouch or other safe disposal option
  • Promote development of evidence-based opioid prescribing guidelines for treating acute pain resulting from specific conditions or procedures
  • Support developing pain drugs that are not addictive, as well as better understanding of safety/efficacy profile of existing opioids



Global operation to crack down on websites selling illegal, potentially dangerous drugs; including opioids

Action against target 465 websites illegally selling dangerous, unapproved versions of opioid, oncology, antiviral prescription drugs to U.S. consumers

  • Global cooperative effort, led by Interpol
  • Target illegal online pharmacies that knowingly and unlawfully distribute illicit drugs both on the surface and dark web
  • Consumers at risk by individuals who put financial gains above patient safety
  • Information on how to buy medicine safely online: BeSafeRx: Know Your Online Pharmacy



Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank

Civil money penalties for violating 42 CFR Part 11, to submit registration
and/or results information to the ClinicalTrials.gov data bank 

  • Identification of violators
  • Circumstances for seeking civil money penalty
  • Procedures for seeking civil money penalty

Civil money penalties may be assessed for

  1. failing to submit required clinical trial registration
  2. submitting false or misleading information to the ClinicalTrials.gov data bank
  3. failing to submit required certification to FDA
  4. knowingly submitting a false certification to FDA

Maximum penalties not more than $10,000 for all violations adjudicated in single proceeding, if a violation is not corrected within 30 days – not more than $10,000 for each day that violation continues 



♥ we stand with the Tree of Life Synagogue and with the Jewish community of Pittsburgh ♥

Image credits: FDA, Interpol

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