Regulatory Recon: Drugmakers Push to Stop Government Price Controls Study Finds More Generic Substitution Could Save Billions (10 May 2016)

Posted 10 May 2016 | By Michael Mezher 

Regulatory Recon: Drugmakers Push to Stop Government Price Controls Study Finds More Generic Substitution Could Save Billions (10 May 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

  • FDA grapples with gray areas in fast-tracking experimental drugs(MedCityNews)
  • A Legal Test for the FDA (WSJ-$) (STAT)
  • Taking the online medicine (The Economist)
  • Exclusive: Patient safety issues prompt leadership shake-up at NIH hospital (Washington Post)
  • Another Study Finds Link Between Pharma Money and Brand-name Prescribing (ProPublica)
  • Top Funds Said to Tell Pharma Leaders to Defend Drug Pricing (Bloomberg)
  • Increasing Support For Generic Drugs And Therapeutic Substitution (CardioBrief) (Reuters) (JAMA 1, 2)
  • FDA Issues Long-Awaited 3D Printing Guidance for Medical Devices (Focus)
  • CDER Issues MAPP for Standards Body Liaisons (FDA)
  • Senate Committee Offers Inside Look at the Rise and Fall of Valeant Pharmaceuticals (Focus)
  • Pfizer to trial triple-combination cancer treatment (Financial Times)
  • Former FDA head: Opioid epidemic one of "great mistakes of modern medicine" (CBS)
  • Drug Price Control: How Some Government Programs Do It (The Commonwealth Fund)
  • Medtronic Suspends Endurant Evo Study To Investigate Stent Fractures (Gray Sheet-$)

In Focus: International

  • A Window Into the Workings of Zika (NYTimes)
  • Daiichi buys Japanese rights to UK heart stem cell therapy (Reuters) (Financial Times)
  • Baidu CEO tells staff to put values before profit after cancer death scandal (Reuters)
  • Scottish Medicines Consortium does not back Vertex' cystic fibrosis drugs Orkambi, Kalydeco (Pharmafile)
  • Navigating Brazil's Emerging Biosimilar Market (BioprocessOnline)
  • CDISC Unveils New Standard for Clinical Trial Registries (Focus)
  • Gilead's $1,000 pill gets patent in India (Economic Times)
  • Should Generic Companies Challenge Patent Term Extension For Rapivab? (24 Insight)
  • Roche commits to diabetes testing and sees 2017 return to growth (Reuters)
  • South African health authorities wants Roche to reduce cancer medication prices (Reuters)

US: Pharmaceuticals & Biotechnology

  • Strategies for Switching or Merging EHRs (Medpage)
  • The Advertising Coalition Reminds FDA of First Amendment Limits to Advertising Regulation (CHC)
  • Injectable Gel Generates New Blood Vessels (MIT Technology Review)
  • There Are Many Reasons To Be Optimistic About Gilead's Prospects (Forbes)
  • Health policy: Affordability of drugs used in oncology health care (Nature)
  • Wave Life Sciences prepares next gen Duchenne drug for trials (PharmaPhorum) (Boston Business Journal)
  • 'No Meaningful Change' In Pricing Environment, Teva Says (Pink Sheet-$)
  • Rethinking the Role of Regulatory in Innovation – Part 1 (Pharmaceutical Compliance Monitor)
  • Regulators See Trend To Reduced Clinical Data Requirements For Biosimilars (SCRIP-$)
  • Ackman Warned Valeant 'Rome Was Burning,' Begged 'Tell The Truth' (Pink Sheet-$)
  • Opioids: FDA Asks If Abuse-Deterrence Incentives Are In Line (Pink Sheet-$)
  • Investigational malaria vaccine protects healthy U.S. adults for more than one year (NIH)
  • US GPhA fears proposed drug payment model's impact on biosimilars (PharmaLetter-$)
  • Special Protocol Assessment Draft Guidance Adds Biosimilars, Not Much Clarity (Pink Sheet-$) (Focus)
  • New PhRMA Report: Medicines in development for patients with rare diseases demonstrate the promise of innovation (PhRMA)
  • PureTech Gets into Cell Therapy With Vor Bio, But Keeps Details Close (Xconomy)
  • Siddhartha Mukherjee, Author Of Bestselling Cancer Book, Starts Biotech Company And Answers Criticism (Forbes)
  • Delivering on the Potential of Biosimilar Medicines (Biosimilar News)
  • Epirus decides to focus on rare disease biosimilars only (Biosimilar News) (Press)

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

  • NewLink's pancreatic cancer vax fails PhIII, platform under scrutiny (Fierce) (PharmaLetter-$)
  • Chimerix now 0 for 2 as brincidofovir flunks another PhIII trial (Fierce) (BioCentury)
  • Cerulean Announces First Patient Dosed in Phase 1/2 Trial Evaluating CRLX101 in Combination with LYNPARZA (Press)

US: Medical Devices

  • FDA to Keep Device Advisory Committee Chair Despite Conflict of Interest (Focus)
  • A Better Prostate-Cancer Test? (WSJ-$)
  • Shuren: FDA Willing to Kickstart Device Evaluation Program, But Funding Guarantee Needed (Gray Sheet-$)
  • FDA Releases Summary of April 6-7 MDUFA IV Reauthorization Meeting (FDA)
  • Masimo wins $36m Defense Dept. contract (MassDevice)
  • Abbott's Tecnis Symfony intraocular lens clears pivotal trial (MassDevice)
  • Microchip Mimics Human Kidneys to Study Toxicity of Drugs (medGadget)
  • GI Dynamics touts new safety, efficacy data for EndoBarrier (MassDevice)
  • Signostics Uscan High Resolution Bladder Scanner FDA Cleared (medGadget)
  • LabCorp Launches Colorectal Cancer Test, But Key Hurdles Remain (Xconomy)
  • FDA releases April 2016 510(k) clearances (MassDevice)
  • FDA nod for wireless continuous blood pressure, heart monitor for remote use (Fierce)
  • ReWalk Robotics touts reimbursement win for powered exoskeleton (MassDevice)
  • NinePoint Medical wins FDA nod for real-time targeting on NvisionVLE device (MassDevice)
  • Wet Lubricants gain 510(k) clearance as a class II medical device (DSN)
  • Unilife plunges after canceling earnings call on ex-CEO's possible 'violations' (MassDevice)

US: Assorted & Government

  • Pesticides, military service may be tied to ALS risk (Reuters)
  • House's Opioid-Week Votes Will Set Up Senate Conference (Morning Consult)
  • Sen. Ayotte Introduces First Responder Anthrax Preparedness Act (Congress)
  • Obama's New Challenge: A Medical Bill You Can Understand (Forbes)
  • Appeals court denies Biolitec in Angiodynamics spat (MassDevice)
  • Gilead Says Secret Info Being Used By Atty In Harassment Suit (Law360-$)
  • Divided Infringement in Patent Law and the Doctor-Patient Relationship (Harvard Bill of Health)
  • FDA Releases Final Rule Related to the Reporting of Antimicrobial Sales and Distribution Information (FDA)
  • Medicaid and CHIP: Increased Funding in U.S. Territories Merits Improved Program Integrity Efforts (GAO)
  • Medicare Advantage: Fundamental Improvements Needed in CMS's Effort to Recover Substantial Amounts of Improper Payments (GAO)
  • FBI says not to pay ransom; data, system backups critical for health systems (Fierce)
  • Clues to Better Health Care From Old Malpractice Lawsuits (WSJ-$)

Upcoming Meetings & Events


  • NICE draft guidance recommends PCSK9 inhibitors for high risk cardiovascular patients (Pharmaceutical Journal-$)
  • So Far, So Good On EMA's PRIME, With One Caveat (SCRIP-$)
  • Cytori Granted Broad European Orphan Drug Designation (Press)
  • GSK finally has Breo where it wants it--just in time for Advair copies (Fierce)
  • Ukrainian government eases access of imported drugs to domestic market (PharmaLetter-$)
  • Europe delays Merck & Co.'s HCV drug on back of CMO quality issues (In-PharmaTechnologist)
  • Incyte buying Ariad's European operations, Iclusig rights (BioCentury)
  • NHS England extends pharmacy flu vaccination scheme (Pharmaceutical Journal-$)
  • Lithuanian SMC switches to e-dossier only starting 01 May 2016 (Exalon)


  • South Korean pharmaceutical market to grow slowly to $20.4 bn by 2020 (BioSpectrum)
  • Beximco posts 15.7% sales growth for 2015 (PharmaLetter-$)
  • JHL Biotech opens biosimilars manufacturing facility in China (BioSpectrum)


  • Companies Should Submit Applications Online In SUGAM Portal, CDSCO Says (24 Insight)
  • CDSCO Calls for Subject Matter Experts to Join Panels (CDSCO)
  • DoP asks NPPA to examine review applications filed by various pharma cos against NPPA's price fixation (PharmaBiz)
  • Government recovers just 7.8% of Rs 4,928 crore drug overcharging fine (Economic Times)
  • High Court Sanctions Natco Pharma's Amalgamation Scheme (24 Inight)
  • Camptosar ANDA Approval Adds More Competition For Generic Market (24 Insight)
  • Licences of 10 drug manufacturers suspended, says government (Economic Times)


  • Health Canada extends compliance deadline for commercially reprocessed medical devices (MassDevice)
  • Regulatory decision summary: COSENTYX SA (Health Canada)


  • Birmingham Hip Modular Head (used in hip replacements) (TGA)


  • White House: Puerto Rico debt crisis could hamper Zika response (Reuters)
  • Caribbean Mosquito Awareness Week launched to raise awareness on preventing Zika (PAHO)
  • Honduras suspects first case of microcephaly in pregnant Zika patient (Reuters)
  • CDC adds Saint Barthelemy to interim travel guidance related to Zika virus (CDC)

Other International

  • Yellow Fever Epidemic: A New Global Health Emergency? (ICT)
  • South Africa faces uphill battle to reduce HIV infection rates among young women (Reuters)
  • South African MCC releases updated eCTD Q&A (Exalon)

General Health & Other Interesting Articles

  • Women Aren't Taking First Place In Top Medical Journals (KHN)
  • Should You Circumcise Your Child? (NYTimes)
  • How To Be A Data-Driven, Informed IVF Patient (Forbes)
  • U.S. maternal death rate is spiking. Here's what's being done to change that. (Washington Post)
  • Swaddling tied to increased risk of SIDS (Reuters) (Washington Post)

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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