Regulatory Reconnaissance (19 February 2013)

Posted 19 February 2013 | By Alexander Gaffney, RAC 

Good morning and welcome to an expanded President's Day weekend edition of Regulatory Reconnaissance, our daily intelligence briefing for the international regulatory affairs space. There's a lot to catch up on from this weekend, including: A new push for a multi-billion dollar study of the human brain, device companies claiming US FDA hurts their ability to innovate, legislators telling US FDA to reclassify painkillers, looming budget sequestration, a landmark biologics case in Australia, new nanotechnology guidance out of the OECD, and reports that EU legislators and the device industry remain at odds with one another over reform proposals. 


  • Obama Seeking to Boost Study of Human Brain (NY Times) (UPI) (Med Page Today)
  • Small med-tech firms say FDA delays hurt innovation (Med City News)
  • FDA Cracks Down on Flu Product Scammers (FDA) (Regulatory Focus)
  • Sandy's Impact on Clinical Trials Still Being Felt (Medpage Today)
  • Congress Tells FDA To Reclassify Painkillers Now (Pharmalot) (The Hill)
  • CMS Proposes 2014 Payment and Policy Updates for Medicare Health and Drug Plans (CMS)
  • Bennet, Burr: IOM Report Shows Need for Continued Push for Track & Trace (Bennet)
  • As sequester looms, House, Senate vote to recess for the week (The Hill)
  • AbbVie Suspends Five Clinical Trials of Leukemia Therapy (Bloomberg)
  • CTTI forms Patient Leadership Council to help drive improvements in clinical trials (CTTI)
  • Analysis: The Hip Replacement Case Shows Why Doctors Often Remain Silent (NYTimes)
  • W.Va. senators, representative introduce prescription drug abuse bill (Drug Store News)
  • FDA lambasts Jamaican manufacturer over sterility, quality (Fierce Pharma Manufacturing)
  • GSK wins priority status for new HIV drug in US (Reuters)
  • Sanofi says Gaucher pill studies meet goals (Reuters)
  • Gilead Recalls One Lot of Vistide Due to Presence of Particulate Matter (FDA)
  • Class I Recall: DePuy Therapeutics' LPS Diaphyseal Sleeves (FDA)
  • Healthcare rule caps prescription drug profit (The Hill)
  • ePedigree & Serialization: What You Need to Know NOW for the California 2015 Deadline (Pharma Manufacturing)
  • USP Labs Slapped With Warning Letter Over Drug Claims, GMP Failures (Nutra Ingredients USA)
  • Democratic Lawmakers Seek To Prevent Pharmacists From Refusing To Fill Birth Control Prescriptions (Think Progress)
  • Is GAIN Good Enough? Infectious Disease Society and Start-Up Companies Push for More Anti-Infective Incentives (RPM Report) ($)
  • Meetings: Neonatal Subcommittee of the Pediatric Advisory Committee (FDA)
  • Workshop: Innovations in Breast Cancer Drug Development - Neoadjuvant Breast Cancer Workshop (FDA)
  • Meeting: Considerations Regarding Food and Drug Administration Review and Regulation of Drugs for the Treatment of Amyotrophic Lateral Sclerosis (FDA)
  • Upcoming Brookings Roundtable on Active Medical Product Surveillance (FDA/Brookings Institute)
  • Congressional Hearing on FDA's Response to Flu Epidemic (FDA Testimony) (Hearing Notice) (Relevant GAO Report)
  • Democratic Lawmakers Seek To Prevent Pharmacists From Refusing To Fill Birth Control Prescriptions (Think Progress)
  • Washington Legal Foundation: Don't Allow Approval of Biosimilars That Use Pre-PPACA Trade Secrets to Support Approval (WLF)
  • Boxer, Coburn Introduce Bill to End Ban on Research into Organ Donations Between HIV-Positive Patients (Boxer)
  • The shifting pharmaceutical industry landscape: Accounting and regulatory trends affecting reporting for   2012 and planning for 2013 (Ernst & Young)
  • FDA starts review of Sanofi's lixisenatide (Pharma Times)
  • Well-Intended Report Calls For Global Track & Trace Of Pharmaceuticals (RxTrace)
  • First Fruits of FDASIA's New Device Reclassification Procedure (FDA Law Blog)
  • DoJ Official: Free Speech Won't Protect Off-Label Promotion (Eye for Pharma)


  • Myriad Genetics Wins Australia Bid to Patent Human Genes (Bloomberg) (BioCentury)
  • CDSCO introduces pre-screening of SAEs to streamline submission of reports (PharmaBiz)
  • Meeting: European Medicines Agency excellence in pharmacovigilance: Clinical trials and post-marketing training course (EMA)
  • Consultation - Invitation to Participate in the Survey for ICH Q7 Constituencies: Input for Development of a Question and Answer Document (Health Canada)
  • Current Developments in Delegations on the Safety of Manufactured Nanomaterials (OECD)
  • Guidance on sample preparation and dosimetry for the safety testing of manufactured nanomaterials (OECD)
  • UK drug access woes "due to US-dominated global pricing, not NICE" (Pharma Times)
  • EU and medical devices industry at odds over regulation (EurActiv)


  • Families Push for New Ways to Research Rare Diseases (WSJ)
  • Pharma gift bans for budding doctors have long-term impact (AMA)
  • What risks do docs who prescribe devices like AliveCor take on? (Mobi Health News)
  • Drug Makers, in Shift, Join Fight Against Doping (NY Times)
  • Is George W. Bush the 'Greatest Humanitarian' President Ever? Thanks to PEPFAR, he Might Be (Foreign Policy) (IOM Report Comes out on 20th)
  • Kidney Damage Is Latest Health Risk Linked With Synthetic Marijuana (JAMA)
  • The High Cost of Health Care: Why Some Pay $240 for a $9 Bottle of Pills (Harvard Bill of Health)
  • Drugmakers weigh carve-outs as Abbott, Pfizer set pace (Reuters)
  • How to make meth, by the U.S. government. Sorta. (Yahoo)
  • Medicine for the Rich Is About to Get Cheap Enough for Regular People (Wired)
  • Bionic Eyes and "Health Care Costs" (Slate)
  • A New Vaccine For Drinking Could Keep Alcoholics Sober (Fast Coexist)
  • Personal QR codes could help first responders get vital patient information (Med City News)

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 or @AlecGaffney and we'll check it out for inclusion in our next edition of Regulatory Reconnaissance.

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