FDA News and Views: Illegal Online Drug Marketing, Patient Preferences for Devices, Digital PreCert Program Selection, Drug Patents and Exclusivities, Compounded Medications – Drug and Device Digest

FDA BRIEF: Week of September 25, 2017


FDA conducts major global operation to protect consumers from potentially dangerous prescription drugs sold online

Operation Pangea X, a global cooperative effort led by Interpol, to combat unlawful sale and distribution of illegal, counterfeit, substandard medical products on the internet

  • Action against > 500 websites illegally selling dangerous, unapproved versions of prescription medicines –  including opioids
  • Remove products from supply chain
  • Prevent health risks as well as credit card fraud, identity theft and computer viruses



How Patient Preferences Contribute to Regulatory Decisions for Medical Devices

Examples of using Patient Preference Initiative as part of medical device regulatory decision-making process

  • Expanded indication for home hemodialysis machine to be used without presence of care partner
  • Worked with medical device company, NxStage, to develop Patient Preference Framework
  • Enhancing safety of continuous glucose monitors – Dexcom G5 Continuous Glucose Monitoring (CGM) System and Animas Vibe System.
  • Used patient feedback to develop risk mitigation strategies such as lockout feature to prevent accidental boluses

Companies invited to discuss on patient preference information during Pre-Submission meetings



FDA selects participants for new digital health software Precertification pilot program

Selection of companies to participate in a first-of-its kind pilot program to revolutionize digital health regulation in the U.S.

  • Pre-cert pilot program is precertify software developers based on systems for software design, validation and maintenance, meeting quality standards
  • Precertified companies could potentially submit less FDA information before marketing a new digital health tool
  • >100 applicants; selection based on company size, demonstrated record of quality and organizational excellence, represent unique approaches  digital health technology development

Apple, Cupertino, California

Fitbit, San Francisco, California

Johnson & Johnson, New Brunswick, New Jersey

Pear Therapeutics, Boston, Massachusetts

Phosphorus, New York, New York

Roche, Basel, Switzerland

Samsung, Seoul, South Korea

Tidepool, Palo Alto, California

Verily, Mountain View, California


CapturePatents and Exclusivities for Generic Drug Products


  • Property right granted by US -PTO -term of 20 years from the date of filing with the PTO
  • FDA does not enforce patents, or evaluate patent validity or infringement
  • Product manufacturers submit patent information to FDA for inclusion in “Orange Book”  –  informs when a generic drug application may be approved


  • Provides limited market protection from new competition; precludes approval of certain ANDAs for prescribed periods of time – Hatch Waxman Amendments
  • Also for brand-name “orphan” drug products- Orphan Drug Act
  • Also for certain pediatric-related uses and for qualifying antibiotic drug products.
  • FDA administers exclusivities

Types of Exclusivities:

  • Five-Year New Chemical Entity
  • Three-Year New Clinical Studies
  • Orphan Drug.
  • Pediatric
  • “Generating Antibiotic Incentives Now” (GAIN)
  • 180-Day



New efforts to encourage compounding of better quality drugs 

Important for health care providers to have access to compounded drugs

  • When patient needs cannot be met by FDA-approved drugs
  • Oversight based on Drug Quality and Security Act (DQSA) to prevent manufacturing issues and associated patient risks
  • Posting  new report  on drugs that entities registered as outsourcing facilities have produced
  • Sharing guide, “Outsourcing Facility Information,” for outsourcing facilities
  • Collaboration with state partners at sixth intergovernmental meeting on drug compounding
  • Assist more compounders register as outsourcing facilities


Image credits: FDA



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