Regulatory Focus™ > News Articles > Regulatory Reconnaissance: The Criminal Enterprise Behind Counterfeit Cancer Drugs (2 May 2014)

Regulatory Reconnaissance: The Criminal Enterprise Behind Counterfeit Cancer Drugs (2 May 2014)

Posted 02 May 2014 | By Alexander Gaffney, RAC

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Read anything we might be interested in sharing? Let us know: news@raps.org.

In Focus: US

  • FDA Denies Petitions Alleging Erroneous Triggering of NCE Exclusivity Start Date Before DEA Controlled Substance Scheduling Permitted Marketing; Litigation to Follow? (FDA Law Blog)
  • Ranbaxy recalls nearly 30,000 packs of allergy-relief drug in U.S (Reuters) (FDA)
  • FDA Launching Mini-Sentinel Probe of Myrbetriq (Mini-Sentinel)
  • CDER Looking for Automated Translational Research System (FDA)
  • Hospira makes progress on plant problems, but problems remain in India (Fierce)
  • FDA clears obstructive sleep apnea implant to overcome adherence issues (MedCity News) (MedGadget) (Press) (AP)
  • 2013 FDA Dietary Supplement Warning Letters Summary (DSE)
  • Upcoming Congressional Roundtable to Include Woodcock, Shuren, von Eschenbach (House)

In Focus: International

  • Italian Officials Probe Criminal Ties to Fake Cancer Drugs (WSJ-$)
  • EMA Draft concept paper on viral safety of plasma-derived medicinal products (EMA)
  • India Will Refuse Unilateral U.S. IPR Probe, Commerce Minister Says (PharmAsia-$)

US: Pharmaceuticals/Biotechnology

  • FDA Denies Petitions Alleging Erroneous Triggering of NCE Exclusivity Start Date Before DEA Controlled Substance Scheduling Permitted Marketing; Litigation to Follow? (FDA Law Blog)
  • Ranbaxy recalls nearly 30,000 packs of allergy-relief drug in U.S (Reuters) (FDA)
  • FDA Launching Mini-Sentinel Probe of Myrbetriq (Mini-Sentinel)
  • CDER Looking for Automated Translational Research System (FDA)
  • New FDA Mapp: Review of Informed Consent Documents in INDs (FDA)
  • Acknowledging Caronia: FDA Takes The First Step To Rethinking Off-Label Policy (RPM Report-$)
  • ISPE Announces Development of New Drug Shortages Prevention Plan for the Pharmaceutical Industry (Press)
  • Review of the FDA Progress on Phasing out Certain Antibiotics: Promise and Problems (Harvard BOH)
  • Ex-Rep Says Forest Labs Pushed Off-Label Use Of Namenda (Law 360-$)

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

  • FDA Issues Complete Response Letter for PLUMIAZ, Investigational Medicine for Epilepsy Cluster Seizures (Press)
  • Merrimack plans pancreatic cancer NDA for MM-398 (SCRIP-$) (BioCentury) (MM&M) (Pharma Letter-$)
  • Vertex says cystic fibrosis drugs shown to boost lung function (Reuters) (BioCentury) (Fierce) (Press)
  • Merck and Endocyte's ovarian cancer drug fails in trial (Reuters) (Press)
  • Prosensa Provides Positive Update on DMD Drug (DD&D)
  • Advaxis Receives Orphan Drug Designation for Treatment of Invasive Cervical Cancer (Press)

US: Pharmaceuticals and Biotechnology: General

  • Three-Drug Protocol Persists for Lethal Injections, Despite Ease of Using One (NYTimes)
  • Botched Oklahoma execution turns spotlight on US pharmaceutical firms (Guardian)
  • The Pharmacology And Toxicology Of Execution By Lethal Injection (Forbes)
  • Pfizer-AstraZeneca Deal Threatens Spending on New Drugs (Bloomberg)
  • Drug Lobbyists Say Plans Should Have Anticipated Sovaldi's Impact (IHP-$)

US: Medical Devices

  • Hospira makes progress on plant problems, but problems remain in India (Fierce)
  • FDA clears obstructive sleep apnea implant to overcome adherence issues (MedCity News) (MedGadget) (Press) (AP)
  • Three Class 1 Recalls for Infusion Pumps Made by Hospira (FDA) (FDA) (FDA)
  • Class I Recall for Baxter Infusion Pump due to System Errors (FDA)
  • Wright revives prospects of bone graft with FDA resubmission (Fierce)
  • HeartWare warns about battery safety in its ventricular assist device (Fierce)
  • Teva Recall for Copper IUD Due to Lack of Sterility Assurance (FDA)
  • FDA Posts Review Materials for Circulatory AdComm Meeting on ResQCPR (FDA)
  • FDA clears McKesson's Cardiology ECG Mobile and two more (MobiHealthNews)
  • GS Medical USA announces FDA clearance and launch of AnyPlus T/PLIF Cage (MNT)
  • CMS Questions Watchman, CardioMEMS Data In New-Tech Add-On Process (Gray Sheet-$)

US: Dietary Supplements

  • 2013 FDA Dietary Supplement Warning Letters Summary (DSE)
  • FTC Urges Advertisers To Police False Weight-Loss Claims (Law 360-$)

US: Assorted And Government

  • Upcoming Congressional Roundtable to Include Woodcock, Shuren, von Eschenbach (House)
  • AHRQ publishes new edition of patient registry reference (BioCentury) (AHRQ)
  • Obama's Regulatory Chief Speaks at Penn Law (RegBlog)

Europe

  • Italian Officials Probe Criminal Ties to Fake Cancer Drugs (WSJ-$)
  • EMA Draft concept paper on viral safety of plasma-derived medicinal products with respect to hepatitis E virus (EMA)
  • Medtronic wins E.U. approval for adaptive, diagnostic Viva pacemaker (Mass Device)
  • EMA advisory committee backs addition for Eliquis SmPC (Pharma Letter-$)
  • Status Update on NBRG Risk Management Consensus Document (Eisner)

India

  • DCGI lays down special conditions to allow import of drugs with residual life less than mandated 60% (PharmaBiz)
  • India Will Refuse Unilateral U.S. IPR Probe, Commerce Minister Says (PharmAsia-$)

General Regulatory And Interesting Articles

  • Can You Afford Your Medicine? Doctors Don't Ask (NYTimes)
  • Opinion: Big Pharma, my cancer patient and me (Guardian)

Regulatory Reconnaissance #310 - 2 May 2014

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.

Did we miss a story? Send us a tweet at @RAPSorg and we'll check it out for inclusion in our next edition of Regulatory Reconnaissance. Want this in your inbox each morning? Sign up for RF Today, our morning intelligence newsletter here.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @AlecGaffney 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.


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