Regulatory Focus™ > News Articles > Regulatory Recon: More on Off-Label and Social Media Drug Marketing (14 August 2015)

Regulatory Recon: More on Off-Label and Social Media Drug Marketing (14 August 2015)

Posted 14 August 2015 | By Michael Mezher 

Regulatory Recon: More on Off-Label and Social Media Drug Marketing (14 August 2015)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher and @RAPSorg on Twitter.

In Focus: US

  • Glaxo to reopen NC plant this weekend after Legionnaires' scare (BioPharmaDive)
  • FDA’s Quality Metrics Proposal Poses Challenges, Including Gaming, Cost (Gold Sheet-$)
  • Trends in breakthrough therapy designation (Nature-$)
  • FDA Testing Regs Should Be Loosened, Allow More Human Models (Pink Sheet-$)
  • FDA Drug Safety Communication: Serious medication errors from intravenous administration of nimodipine oral capsules (FDA)
  • Roche will use app to track Parkinson’s symptoms in drug trial (MobiHealthNews)
  • How is off-label medication use linked to the First Amendment? (MedCityNews)
  • Amarin and Off-Label Marketing: Firm Wins, But Will Patients Lose? (Medpage Today)
  • FDA: IDE review times reduced by nearly a year (MassDevice)
  • FTC Resolves Claims Over 'Cancer-Detecting' Apps (Law360-$)

In Focus: International

  • The EU Safeguard Clause, The Last Ditch Measure, Is Not Being Used (Clinica-$)
  • EU Postmarket Efficacy Studies To Get More 'Predictability' (Pink Sheet-$)
  • WHO Director-General briefs the UN Security Council on the Ebola situation (WHO)
  • CFDA Says ‘Bring It On’ As Clinical Data Stress Test Nears (PharmAsiaNews-$)
  • USP Strengthens Relationship with China to Improve Quality of Medicines and Food (USP)
  • Taiwan FDA Inspector Charged in Bribery Probe, Drugmakers Questioned (Pharmaceutical Manufacturing)

US: Pharmaceuticals and Biotechnology

  • FDA’s Quality Metrics Proposal Poses Challenges, Including Gaming, Cost (Gold Sheet-$)
  • Trends in breakthrough therapy designation (Nature-$)
  • FDA Testing Regs Should Be Loosened, Allow More Human Models (Pink Sheet-$)
  • FDA Drug Safety Communication: Serious medication errors from intravenous administration of nimodipine oral capsules (FDA)
  • Impossibility Preemption for Innovator Drug Manufacturers: Where Are We Now? (Drug and Device Law)
  • Glaxo to reopen NC plant this weekend after Legionnaires' scare (BioPharmaDive)
  • Excipient manufacturers raise concerns over stability testing (In-Pharma Technologist)

US: Pharmaceuticals and Biotechnology: Clinical Study Results, Filings and Designations

  • Roche will use app to track Parkinson’s symptoms in drug trial (MobiHealthNews)
  • Basilea's Ceftobiprole Dubbed Qualified Infectious Disease Product (SCRIP-$)
  • FDA Approves BioDelivery's New Formulation of Onsolis (DD&D)
  • FDA Approves U.S. Product Labeling Update for Sprycel (Press)
  • Phase I results for candidate adalimumab, etanercept and infliximab biosimilars (GaBI)
  • GSK hopes big clinical trial can breath new life into lung drug (Reuters)
  • Reformulated Onsolis OK'd; Market Entry Not Until 2016 (SCRIP-$)
  • New Anti-Clotting Drug Savaysa Can Be Dangerous As It Has No Treatment Approved To Reverse The Anti-Coagulant Effect (Drug Injury Watch)
  • FDA Pushes Back Decision on Expanded Use of Bristol-Myers Squibb Drug Opdivo (WSJ)
  • FDA Expands Bleeding Prevention Use for Wilate (MPR)
  • Octapharma USA: FDA Approves WILATE® License Supplement (Press)
  • Baxter and Water Street Announce FDA Approval of CEFAZOLIN 2 Gram Premix (Press)

US: Pharmaceuticals and Biotechnology: General

  • Kim Kardashian, Dr. Oz And TV Drug Ads (Forbes)
  • Economist: Pharmas Are Protected 'Fragile Little Birds' (SCRIP-$)
  • How is off-label medication use linked to the First Amendment? (MedCityNews)
  • Amarin and Off-Label Marketing: Firm Wins, But Will Patients Lose? (Medpage Today)
  • Wither Off-Label? (DrugWonks)
  • Desperately Seeking Price Reform: Pharma Needs To Embrace Transparency & Value to Protect Innovation (Forbes)
  • GPhA Warns FDA On ANDA Review Transparency (Pink Sheet-$)
  • Umbrella Branding Is ‘Particular Concern’ As FDA Requests Research Proposals (Pink Sheet-$)
  • Antidepressant drug trials criteria not generalizable (MNT)

US: Medical Devices

  • FDA: IDE review times reduced by nearly a year (MassDevice)
  • Boosting Medical Device Safety with Big Data Analytics (MDDI)
  • Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices (FDA)
  • UCSF Med Center Patients Exposed to Possibly Contaminated Device (California Healthline)
  • Firm Says It Cannot Afford Settlement Over Lap-Band Ads in California (California Healthline)
  • Counterfeit tourniquets could cost lives (CBS)
  • Draft: Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses (FDA)
  • Zyga wins 510(k) for Simmetry fusion system (MassDevice)
  • Feds come down in support of subsidizing copays in some clinical trials (FierceMedicalDevices)

US: Assorted and Government

Upcoming Meetings and Events              

  • RAPS' FDA Advisory Committee Meeting Tracker
  • Neurodiagnostics and Non-Invasive Brain Stimulation Medical Devices Workshop, November 19-20, 2015 (FDA)
  • Science Advisory Board to the National Center for Toxicological Research Advisory Committee (FDA)
  • Neurodiagnostics and Non-Invasive Brain Stimulation Medical Devices; Public Workshop (FDA)
  • Patient and Consumer Stakeholder Meeting - MDUFA Reauthorization, September 15, 2015 (FDA)

Europe

  • The EU Safeguard Clause, The Last Ditch Measure, Is Not Being Used (Clinica-$)
  • MHRA Advertising Investigations: July 2015 (MHRA)
  • EU Postmarket Efficacy Studies To Get More 'Predictability' (Pink Sheet-$)
  • EU stands by call for Ireland to reduce drug prices (GaBI)

China

  • CFDA Says ‘Bring It On’ As Clinical Data Stress Test Nears (PharmAsiaNews-$)
  • USP Strengthens Relationship with China to Improve Quality of Medicines and Food (USP)

Ebola Outbreak

  • WHO Director-General briefs the UN Security Council on the Ebola situation (WHO)

Other International

General Health and Other Interesting Articles

  • Scientists use bioengineered yeast instead of poppies to make opioids (Reuters)
  • Medical Information Call Centers: Establish Clear Processes for Adverse Event Reporting (Cutting Edge Info)

Regulatory Reconnaissance #618 – 14 August 2015

Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @Michael_Mezher or send him an email at news@raps.org.

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.


Categories: Recon, Regulatory News

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