Regulatory Recon: New Initiative to Cut Medicare Part B Spending Draws Backlash from PhRMA, Oncologists (9 March 2016)

Posted 09 March 2016 | By Michael Mezher 

Regulatory Recon: New Initiative to Cut Medicare Part B Spending Draws Backlash from PhRMA, Oncologists (9 March 2016)

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

In Focus: US

In Focus: International

  • China signals price cuts for cancer drugs, imports (Reuters)
  • Bristol-Myers Squibb shakes up China operations to combat bribery (Financial Times) (Reuters)
  • PMDA Aims to Complete 70% of Priority Reviews Within 9 Months in 2016 (PharmaJapan)
  • Trans-Pacific Partnership Provisions in Intellectual Property, Transparency, and Investment Chapters Threaten Access to Medicines in the US and Elsewhere (PLOS)
  • Merck Loses Patent in India Due to Section 3(D) Objections – Granted in US & Europe (24 Insight)
  • EMA Works On Definition To Support Similarity Assessments For Orphan Drugs (SCRIP-$)

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US: Pharmaceuticals & Biotechnology

  • Sarepta says yet to receive new date for panel review of muscle wasting drug (Reuters)
  • Pediatric Study Plans: FDA Unveils Revised Draft Guidance (Focus)
  • Drug makers now spend $5 billion a year on advertising, Here's what that buys (STAT)
  • What's in a biotech name? How drug startups choose their brand (STAT)
  • CBER Calls on HCT/P Manufacturers to Report Adverse Events Within 15 Days (Focus)
  • FDA Researchers Advance Science for Vaccines to Prevent Mumps and Whooping Cough (FDA)
  • Reducing Waste In Combo Product Reviews: FDA Goes Lean (Pink Sheet-$)
  • DTC Safety Messages Could Vary By Platform As FDA Considers Screen Size (Pink Sheet-$)
  • Zarxio Labeling Updated With New Warning (MPR)
  • 2016 GPhA Annual Meeting – Driving Innovation & Affordability (Thomson Reuters)
  • US FDA Plans Up-Classification of Blood Lancets (Emergo)
  • US FDA backlog holding up revamp of inactive ingredients database (In-PharmaTechnologist)
  • World's First Chief Precision Medicine Officer On Using Patient Biology To Shepherd Clinical Trials (SCRIP-$)
  • The advantages of Enabled-First-in-Human programs (Outsourcing-Pharma)
  • Controversial, Ill-Fated Obesity Drug Trial Published In JAMA (CardioBrief)
  • Socializing Medicine – FDA Enforcement Involving Social Media (Eye on FDA)
  • Criminals can manipulate drug production if IT systems not protected says expert (In-PharmaTechnologist)
  • Anti-malarial drug mefloquine can be taken by pregnant women (Pharmaceutical Journal)
  • Next-generation psoriasis battle lures AbbVie (EP Vantage)
  • Genmab announces Arzerra development plans (PharmaLetter-$)
  • Where Are All The Women With Arousal Disorder? (Forbes)
  • FDA clears PRO for exploratory use in COPD (BioCentury)
  • Herpes Vaccine Cuts Viral Shedding (MedpageToday)
  • Cardiovascular and Renal Outcomes of Renin–Angiotensin System Blockade in Adult Patients with Diabetes Mellitus: A Systematic Review with Network Meta-Analyses (PLOS)
  • Predicting potential pharma side effects (MNT)

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

  • BRIEF-AstraZeneca says U.S. FDA grants orphan drug status for potential eye drug (Reuters)
  • Alnylam Initiates Phase 1/2 Clinical Trial for ALN-GO1, an Investigational RNAi Therapeutic for the Treatment of Primary Hyperoxaluria Type 1 (PH1) (Press)
  • Omeros Corporation Initiates its Phase 3 Program for OMS721 in aHUS Following Meeting with FDA (Press)
  • Cepheid Announces First FDA-Cleared Test for Detection of Carbapenem Resistance Genes in Isolates of Multidrug Resistant 'Superbugs' (Press)
  • Life Spine® Announces FDA Clearance of PROLIFT Expandable Interbody System (Press)

US: Medical Devices

  • Changes to the FDA Routine Inspection Plan: Will This Help FDA? (Medical Device CRO Blog)
  • FDA warns on mag interference between breast expanders, ICD/pacers (MassDevice) (FDA)
  • Industry, FDA Outline Costs Of New MDUFA Proposals; Quality Management A Strong Focus (Clinica-$)
  • Majority of IV Medication Errors Linked to Clinical Practice, Not Technology (ICT)
  • Health apps often lack privacy policies and share our data (Reuters)
  • FDA approves trial for Inari Medical's clot-busting FlowTriever (MassDevice)
  • Theranos Ignored Red Flags On Its Blood Clot Tests (CardioBrief)
  • J&J's Ethicon touts Evarrest in study of aortic repair (MassDevice)
  • Nanovis wins NIH grant for FortiCore (MassDevice)

US: Assorted & Government

  • Burwell: Guidance on march-in rights not needed (BioCentury)
  • What Ted Cruz Gets Wrong About The FDA: Tough Regulation Can Spark Innovation (Forbes)
  • Biosimilar Patent Dance, Or Musical Chairs? Amgen Says Sandoz Can't Stop Music (Pink Sheet-$)
  • FDA Sends Warning Letters To Cannabis Companies Over False Claims (Forbes)
  • Cancer care provider to pay U.S. $34.7 million over improper procedure: DOJ (Reuters)
  • Medicaid Rules Can Thwart Immigrants Who Need Dialysis (NPR)
  • J&J Unit Slams Diabetes Drug Blood Disorder Claims (Law360-$)
  • FDA names new acting director of the Office of Dietary Supplement Programs (DSN)
  • Changes in Leadership for FDA's Foods and Veterinary Medicine Program (FDA)

Upcoming Meetings & Events


  • Pharmacy regulator confirms that it is still seeking surveillance powers (Pharmaceutical Journal-$)
  • EU Notified Body Challenge: Numbers Down, Performance Questioned (Gray Sheet -$)
  • French Trial Tragedy: Experts Recommend Tighter Phase I Rules (SCRIP-$) (Pharmafile)
  • European regulator ready for Prime time (EP Vantage) (Focus)
  • NICE to reject Humira for inflammatory skin disease (PharmaTimes)
  • Occupied wheelchairs in cars and private transport – reminders of safe use (MHRA)


  • Asia Regulatory Roundup: China Focuses on Generic Drug Quality, Efficacy (8 March 2016) (Focus)
  • Suspension Of China Drug Track And Trace Platform Prompts Spat (SCRIP-$)
  • Toshiba Grants Canon Exclusive Rights for Medical Unit Bid (Bloomberg)
  • Roche receives China Food and Drug Administration (CFDA) approval for the CINtec PLUS Cytology test to help prevent women from developing cervical cancer (Press)
  • Taiwan's PharmaEngine gets local FDA approval for Onivyde (PharmaLetter-$)
  • Asia-Pacific asthma therapeutics market expected to hit $5.6 billion in five years (PharmaLetter-$)
  • Japan OKs NuVasive's Reline spine fixation system (MassDevice)


  • Health sector has been given 'top' priority in budget: J P Nadda (Economic Times)
  • Zydus Cadila gets tentative USFDA nod for cancer cure (Economic Times)
  • Cap profits, cut drug prices: Panel (Economic Times) (24 Insight)
  • Can Premium-Priced Trulicity Prickle Victoza In India? (SCRIP-$)
  • Whistleblower raises questions on DCGI, drug regulatory system (Economic Times)
  • Need to restructure TB programme, involve more private players: J P Nadda (Economic Times)
  • Unichem Lab gets USFDA nod for schizophrenia tablets (Economic Times)
  • Time frame for prescriptions needs to be fixed to stall medication mismanagement: Dr Jagashetty (PharmaBiz)


  • Medical Devices: how to stay included (TGA)
  • TGA issues safety alert about EpiPen Adrenaline Auto-injector (TGA)

Zika Virus

  • FDA Wants to Add Zika Virus Sequence to Database (MDDI)
  • First Case of Acute Myelitis in a Patient Infected With Zika Virus (ICT)
  • HHS Ships Blood Products to Puerto Rico in Response to Zika Outbreak (ICT)
  • CDC director calls Zika in Puerto Rico a 'challenge and crisis' (Reuters)
  • WHO Director-General addresses media after Zika Emergency Committee (WHO)
  • WHO advises pregnant women to avoid travel to Zika-affected areas (Reuters)
  • WHO statement on the 2nd meeting of IHR Emergency Committee on Zika virus and observed increase in neurological disorders and neonatal malformations (WHO

General Health & Other Interesting Articles

  • Scientists Uncover History of Ancient Viruses (ICT)
  • No paid sick leave means workers skip medical care (Reuters)

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

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

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