Regulatory Recon: Two Former Pharma Execs Charged With Price Fixing FDA Extends Comment Period for Off-Label Promo Comments (15 December 2016)

Posted 15 December 2016 | By Zachary Brennan 

Regulatory Recon: Two Former Pharma Execs Charged With Price Fixing FDA Extends Comment Period for Off-Label Promo Comments (15 December 2016)

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

In Focus: US

  • CDER Director Woodcock Interview (CNBC)
  • Two Former Drug Execs Charged With Price Fixing (NY Times-$) (Bloomberg)
  • Google’s Long, Strange Life Span Trip (MIT Tech Review)
  • OIG Finalizes Antikickback Law Safe Harbors and CMP Rules that Would Offer Additional Protections for Pharmaceutical and Device Manufacturers (FDA Law Blog)
  • Eucrisa gets FDA nod in atopic dermatitis ahead of PDUFA date (BioWorld-$) (Endpoints) (PMLive)
  • HHS’ Burwell on what does the future of the Affordable Care Act look like? (NPR)
  • HHS Report to Congress: Prescription Drugs: Innovation, Spending, and Patient Access (Report)
  • Drugmakers push profitable, but unproven, opioid solution (Center for Public Integrity)
  • FDA to Extend Comment Period for Unapproved Use Communications Public Hearing (FDA)
  • Regulating Off-Label Promotion — A Critical Test (NEJM)
  • Congress Just Quietly Handed Drug Companies a Dangerous Victory (New Republic)
  • Better Tool to Help Assess LASIK Patients (FDA)
  • Electronic Informed Consent: Final Q&A Spells Out New Recommendations (Focus)
  • FDA Tells Sanofi and Celgene to Stop Airing Misleading TV Advertisements (Focus)
  • New FDA Warnings for Anesthetic Use in Young Children and Pregnant Women (Focus)

In Focus: International

  • PIC/S Signs Agrement With EEA Heads of Medicines Agencies (PIC/S)
  • ICH guideline Q3C (R6) on impurities: guideline for residual solvents (Final CHMP Adoption)
  • Document classification policy (EMA)
  • New reforms for Scottish medicines approval process (PharmaTimes) (Government Report)
  • Brexit likely to cause long-term damage to UK pharma, say industry leaders (PharmaPhorum)
  • HSE chief not optimistic on reaching price deal for Orkambi (Irish Times)
  • Britain agrees to license three-parent IVF babies to prevent disease (Reuters)
  • The Ph. Eur. Commission concludes its pilot phase for biotherapeutics (EDQM)
  • Updated - Guidance Document: Preparation of Regulatory Activities in the “Non-eCTD Electronic-Only” Format (Health Canada)
  • Sanofi commits more than $210M to Brazil distribution operation (FiercePharma)
  • Dr Halfdan T. Mahler, WHO’s third Director-General, dies at 93 (WHO)

Pharmaceuticals and Biotechnology

  • Lonza to buy U.S. drug capsules maker Capsugel from KKR for $5.5 billion (Reuters)
  • Can the new CEO at Genentech maintain a tradition of groundbreaking R&D? (Endpoints)
  • Rx Price Watch Report: Trends in Retail Prices of Brand Name Prescription Drugs Widely Used by Older Americans: 2006 to 2015 (AARP)
  • GSK chief: Immuno-oncology isn't cost-effective for global cancer treatment (FiercePharma)
  • Gilead and Express Scripts make peace in hep C with 2017 formulary deal (FiercePharma)
  • How much can a new EVP help Valeant's badly battered derm unit? (FiercePharma)
  • NYC To Create $100M Life Sciences Campus (Law360-$)
  • Case for Sanofi bid for Actelion could be hard to make, says pharma strategist (PharmaLetter-$)
  • bluebird bio and apceth Biopharma Establish Commercial Drug Product Manufacturing Agreement (Press) (InPharma-Technologist)
  • MSKCC Collaborates With Hackensack Meridian Health in Precision Medicine (OncLive)

Pharmaceuticals and Biotechnology: Clinical Study Results, Filings and Designations

  • Sinoatrial node cardiomyocytes derived from human pluripotent cells function as a biological pacemaker (Nature Biotechnology)
  • After Second-Line RCC Approvals, Focus Shifts to Frontline (OncLive)
  • Nivolumab Shows Promise in Mesothelioma (OncLive)
  • Novocure's noninvasive brain cancer therapy could succeed in ovarian cancer (FierceBiotech)
  • Flagship takes on a pioneering new fund — and name — adding $285M to advance its startup mission (Endpoints)
  • Xtandi fails a combo study, blocking a path to continued use for Pfizer, Astellas (Endpoints)

Medical Devices                                

  • Key elements of a viable post-market surveillance system (Mass Device)
  • J&J’s LifeScan wins FDA clearance for WellDoc integration of blood glucose data (Mass Device)
  • Clarius wins FDA 510(k) for wireless ultrasound device (Mass Device)
  • Trovagene Axes 20 Staffers, Refocuses on Distributing Kits, Systems (GEN)
  • Siemens to pump $300M into MA lab diagnostics plant (FierceBiotech)

US: Assorted and Government

  • Lawsuit Urges FDA to Protect Salon Workers, Consumers from Formaldehyde (EWG)
  • How Republicans Can Rescue E-Cigs from the FDA (Weekly Standard)
  • New HHS Kickback Safe Harbors Are Subject To Many Conditions (National Law Review)
  • Senate Republicans Look to States on Future of Medicaid (BNA)

Upcoming Meetings and Events               


  • European Crohn's, Colitis group supports infliximab to Celltrion's biosimilar switch (BioWorld-$)
  • EuroBiotech Report: Woodford’s loss, BioInvent’s major failure, Pulmagen wants a partner, Amcure’s raise, and Bayer/Versant launch upstart (FierceBiotech)
  • EuroBiotech: More Articles of Note (FierceBiotech)
  • HPRA Drug Safety Newsletter (HPRA)
  • First WHO toolkit to strengthen Europe’s health response to migration (WHO)
  • CRUK research arm starts first-in-class Bicycle Therapeutics trial in cancer (FierceBiotech)


  • MHLW Drafts Optimal Use Guidelines for Opdivo in NSCLC (Pharma Japan)

Other International

  • Canada to ban asbestos use by 2018 (Globe and Mail)
  • International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Bioequivalence: Blood Level Bioequivalence Study; Guidance for Industry; Availability (Federal Register)

General Health and Other Interesting Articles

  • “Zombie” Outbreak Caused by the Synthetic Cannabinoid AMB-FUBINACA in New York (NEJM)
  • U.S. Zika Registry Shows 6% Rate of Defects (MedPage Today) (JAMA Editorial)
  • California Lawmakers Aim To Pay Dentists More To Treat Poor Patients (KHN)
  • What Does Vaccinating Cows Have To Do With A Girl's Education? (NPR)
  • CDC Declares Texas Town a 'Yellow' Zika Virus Zone (NBC)

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.

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

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