Regulatory Reconnaissance: Back from Vacation, Back to Regulation (2 January 2013)

Good morning everyone. We're glad to be back after a long and restful vacation, and we hope you-our readers-had the chance to relax as well. This Regulatory Reconnaissance has all the news since our last update on 21 December 2013. Which is to say, quite a bit of news. While we didn't include quite as many sources for each story, you should find a pretty comprehensive overview of what went on in the industry. - Alexander ([email protected])

In Focus: US

• FDA's 2013 NME approvals below 2012 total (BioCentury) (AP) (SCRIP-$)
• FDA Turns Down MS Drug Lemtrada (MedPage Today) (Reuters) (WSJ-$)
• Industry's joint principles on clinical data-sharing take effect (Pharma Times)
• FDA approves Novo Nordisk's drug for rare blood clotting disorder (Reuters) (Fierce) (FDA)
• In surprise reversal the FDA approves United's oral PAH drug Orenitram (Fierce)
• Hospira's India plant disappoints the FDA again (Fierce)
• Unreported Robot Surgery Injuries Open Questions for FDA (Bloomberg)
• I Had My DNA Picture Taken, With Varying Results-or Why FDA is Skeptical of DTC DNA Testing (NYTimes)
• Study: Hip implant regulatory review 'entirely inadequate' (Mass Device)
• Spike in Harm to Liver Is Tied to Dietary Aids (NYTimes)
• 2013: The Year FDA Got Serious with Supplements (NPI)

In Focus: International

• EU Parliament, ministers agree to more clinical trial transparency in clinical trials (EurActiv) (PMLive)
• EU Clinical Trial Regulations Put Research Timelines At Risk (Pink Sheet-$)
• EMA Looks Back on 2013 (EMA)
• EU medtech notified bodies face code compliance audits (Clinica-$)
• Biopharmaceuticals need adaptable regs industry group tells EC (Biopharma Reporter)
• China investigates after vaccine suspected in seven deaths (Reuters) (NYTimes)
• China halts imports of Pfizer drug on paperwork glitch (Reuters)
• China ban for corrupt pharma firms (Pharmafile)
• India's Efforts to Aid Poor Worry Drug Makers (NYTimes)
• Pharma units will soon be asked to set up exclusive patient safety monitoring cells (PharmaBiz)
• India Mulls Phased-In Ban On Plastic, PET Bottles For Some Drugs (PharmAsia-$)

US: Pharmaceuticals/Biotechnology

• FDA's 2013 NME approvals below 2012 total (BioCentury) (AP)
• FDA Turns Down MS Drug Lemtrada (MedPage Today) (Reuters) (WSJ-$)
• Why the FDA didn't approve Genzyme's multiple sclerosis drug, Lemtrada (BioFlash)
• U.S. FDA approves Novo Nordisk's drug for rare blood clotting disorder (Reuters) (Fierce) (FDA)
• Amarin's Vascepa Will Get Two FDA Decisions, But Is That Good News? (Pink Sheet-$)
• In surprise reversal the FDA approves United's oral PAH drug Orenitram (Fierce)
• New Legislation Would Legalize Personal Importation of Certain Foreign Drugs (FDA Law Blog)
• REMS Communications Need FDA Logo To Boost Doctors' Attention, Advisors Say (Pink Sheet-$)
• FDA's Call for Quality: Revamped GMP Initiative Stresses Cost Savings (RPM Report-$)
• Hospira's India plant disappoints the FDA again (Fierce)
• The Drug Quality and Security Act - Mind the Gaps (NEJM)
• 2013 was springboard for 'breakthrough' drugs (SCRIP-$) (Deal Pipeline)
• SOBI 'temporarily' withdraws Orfadin oral suspension NDA on FDA info request (SCRIP-$)
• Actavis Receives Complete Response Letter from FDA For Progestin-Only Patch (Press)
• US FTC rescheduled workshop on state regulations and naming conventions set for February (Pharma Letter-$) (Washington Times)
• FDA AdComm to Discuss oocyte modification in assisted reproduction for the prevention of transmission of mitochondrial disease or treatment of infertility (FDA)
• Strategies To Address Hemolytic Complications of Immune Globulin Infusions; Public Workshop (FDA)
• International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs (FDA)
• FDA announces voluntary nationwide recall of all non-expired sterile drugs from Abrams Royal Compounding Pharmacy (FDA)
• Hospira Issues a Voluntary Nationwide Recall of One Lot of Lidocaine HCl Injection, USP, 2%, 5 Ml in 5 Ml Vial, Due to Presence of Particulate Matter (FDA)
• Baxter Initiates Worldwide Voluntary Recall Of Select Lots Of 5% Dextrose Injection, USP And 0.9% Sodium Chloride Injection, USP Intravenous (IV) Solutions (FDA)

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

• Industry's joint principles on clinical data-sharing take effect (Pharma Times)
• Sanofi Will Share Clinical Trial Data, But There Is A Caveat (Forbes)
• FDA agrees to review Lilly/BI's Lantus biosimilar (Pharma Times)
• Veloxis seeks FDA OK for kidney transplant drug Envarsus (SCRIP-$)
• Merck's Ragwitek AIT Gets AdComm Date (FDA)
• FDA lifts hold on studies testing Cell Therapeutics' cancer drug (Reuters)
• FDA refuses Photocure's fast track application for Cevira (SCRIP-$)
• TaiGen's Taigexyn gains FDA 'infectious disease' status (SCRIP-$) (Press)
• Eli Lilly and Company and Boehringer Ingelheim announce new drug application filing in the U.S. for new insulin glargine product (Press)
• Takeda suffers a big blow to its diabetes pipeline with PhIII failure of TAK-875 (Fierce)
• Takeda Announces Extension of FDA PDUFA Action Date for Vedolizumab for Ulcerative Colitis (Press)
• Veloxis Pharmaceuticals Envarsus Granted Orphan Drug Status by FDA for Kidney Transplant Rejection Prophylaxis (Press)
• Priority Review for Cubist's tedizolid (BioCentury)
• FDA path forward for Probuphine requires study; Titan tumbles (SCRIP-$)
• Tesaro's Rolapitant Hits Primary Endpoints, But Still Disappoints (Pink Sheet-$) (Fierce)
• GlaxoSmithKline wins FDA 'breakthrough' tag for malaria treatment (Fierce) (Press)

US: Pharmaceuticals and Biotechnology: General

• $100M victims fund eyed in NECC case (AP) (CBS)
• $1,000 Pill For Hepatitis C Spurs Debate Over Drug Prices (NPR)
• The Most Important New Drug Of 2013 (Forbes)
• Prices soar for some generic drugs (SF Gate)
• Critics of 'Me-Too Drugs' Need to Take a Chill Pill (WSJ-$)
• The Fix Isn't In: Why a Safety Device That Can Stop Overdoses by Kids Isn't Widely Used (ProPublica)
• GAO: HHS Is Monitoring the Progress of Its Medical Countermeasure Efforts but Has Not Provided Previously Recommended Spending Estimates (GAO)
• Drugmaker Names Pill After CEO Who Sought Daughter's Cure (NPR)
• Drug-Related Topics Among PCORI Priorities For Large Pragmatic Clinical CER Trials (Pink Sheet-$) (PCORI)
• J&J moves forward with its plan to make Doxil in part of the closed Ben Venue plant (Fierce)
• Drug Firms Ask Senate For Narrow Patent Troll Bill (Pink Sheet-$)

US: Medical Devices

• Unreported Robot Surgery Injuries Open Questions for FDA (Bloomberg)
• I Had My DNA Picture Taken, With Varying Results-or Why FDA is Skeptical of DTC DNA Testing (NYTimes)
• Study: Hip implant regulatory review 'entirely inadequate' (Mass Device)
• Abbott forks over $5.5M to settle physician kickback allegations (Fierce) (Gray Sheet-$) (DOJ)
• FDA gets serious about improving medical device innovation for kids (Mass Device)
• FDA To Incorporate Software In Single Audit Pilot, Modification Guide (IHP-$)
• OMB Signs off on MBAN Rule (FCC)
• FDA, IMDRF and Dept. of Commerce Holding Regulatory Capacity-Building Meeting (AHWP)
• US FDA prepares to chair IMDRF, expects 2014 to be productive for medtech harmonization (Clinica-$)
• mHealth regulatory framework nowhere near settled in 2013 (GovHealthIT) (mHealthNews)
• AdComm Meeting Scheduled for STAAR Surgical's Visian Toric Implantable Collamer Lens (FDA)
• February AdComm Meeting to Discuss Iontophoresis Devices (FDA)
• External Counter-Pulsating Devices for Treatment of Chronic Stable Angina now Class II (FDA)
• Intra-Aortic Balloon and Control Systems for Acute Coronary Syndrome, Cardiac and Non-Cardiac Surgery, or Complications of Heart Failure now Class II (FDA)
• Temporary Mandibular Condyle Prosthesis now Class II (FDA)
• Voluntary Field Corrective Action Initiated for Vital Signs Device's CO2 Multi Absorber Due to a Health Risk (FDA)
• Stryker Acquisition: Yes, Virginia, There Is A Market For Patient Safety (Forbes)
• Solana Surgical lands FDA clearance for orthopedic implant (Mass Device)
• Reverse Medical lands FDA 510(k) win for vascular plug (Mass Device)

US: Dietary Supplements

• Spike in Harm to Liver Is Tied to Dietary Aids (NYTimes)
• 2013: The Year FDA Got Serious with Supplements (NPI)
• Firm in Virginia governor's supplement scandal gets FDA warning (Reuters)(NPI)
• 1/3 of Supplement Industry Struggling to Meet GMPs (NPI)
• FDA warns consumers not to use muscle growth product (FDA) (FDA)
• 2013 warning letters: NDIs, beverage vs supplement, and brand holders' obligations among important themes (NI-USA)

US: Assorted And Government

• FDA's Year in Review (FDA)
• US Capitol Capsule: Biopharma had 2013 legislative wins, despite 'Do-nothing' Congress (SCRIP-$)
• US Recovers $1.8 Billion from Pharma, Device Companies in 2013 (DOJ)
• Hamburg: FDA a Driver of Innovation (FDA)
• Upcoming Meeting for Science Advisory Board to the National Center for Toxicological Research (FDA)

Upcoming Meetings And Events

• 10 January 2013: National Biodefense Science Board Meeting (DHHS)
• 28-29 January 2013: Workshop - Strategies to Address Hemolytic Complications of Immune Globulin Infusions (FDA)
• 2014 FDA OAGS Small Business Outreach Vendor Fair (FDA)
• Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

• EU Parliament, ministers agree to more clinical trial transparency in clinical trials (EurActiv) (PMLive)
• EU Clinical Trial Regulations Put Research Timelines At Risk (Pink Sheet-$)
• EMA Looks Back on 2013 (EMA)
• EU medtech notified bodies face code compliance audits (Clinica-$)
• Biopharmaceuticals need adaptable regs industry group tells EC (Biopharma Reporter)
• A Well-Thought-Out Immunogenicity Clinical Evaluation is Needed to Overcome Prediction Limitations for MAbs, NIBSC Expert Cautions (IPQ-$)
• Lundbeck secures EU approval for Cipralex successor (SCRIP-$) (Reuters)
• Otsuka files twice FDA-rejected kidney drug tolvaptan in EU (SCRIP-$) (Press)
• Actelion gets second boost for Opsumit with EU approval (Fierce)
• Predicting the future of EU genetic testing regulation - opportunities and pitfalls (Clinica-$)
• NICE favours Cell Therapeutics' Pixuvri/Bayer's Eylea (Pharma Times)
• NICE backs Ferring's Firmagon for prostate cancer subgroup (BioCentury)
• Stelara And Firmagon Suffer Setbacks In Draft NICE Appraisals (Pink Sheet-$)
• GSK adds detailed clinical trial data to multi-sponsor request system as part of continued commitment to data transparency (GSK)
• Baxter's VIVIA High Dose Hemodialysis System Gets CE Mark (MedGadget)

China

• China investigates after vaccine suspected in seven deaths (Reuters) (NYTimes)
• China halts imports of Pfizer drug on paperwork glitch (Reuters)
• China ban for corrupt pharma firms (Pharmafile)
• New Chinese quality standards raise the risk of a hep B vaccine shortage (Fierce)
• China takes aim at poor-quality drug production (Fierce)
• Philippines FDA Recalls China Firm's Misbranded Anti-Bacterial Drug (PharmAsia-$)

India

• India's Efforts to Aid Poor Worry Drug Makers (NYTimes)
• Pharma units will soon be asked to set up exclusive patient safety monitoring cells (PharmaBiz)
• India Mulls Phased-In Ban On Plastic, PET Bottles For Some Drugs (PharmAsia-$)
• CDSCO to focus on strengthening PvPI & haemovigilance programme next year (PharmaBiz)
• New panel to suggest guidelines for verifying over 5000 FDCs approved without DCGI clearance but still in market (PharmaBiz)
• WHO's Uppsala Monitoring Centre looks to make India as hub for pharmacovigilance training (PharmaBiz)

Other International

• Brazil govt "hindering market entry of new HIV drugs" (Pharma Times)
• TGA Reforms: A blueprint for TGA's future: Progress report as at 30 June 2013 (TGA)
• Canada: Guidance for Industry: Management of Drug Submissions (HC)
• Canada: Guidance Document for Industry and Practitioners - Special Access Programme for Drugs (HC)

General Regulatory And Interesting Articles

• Flu vaccine may work better for women than men (CBS)
• Survey of consent practices in cluster randomized trials: Improvements are needed in ethical conduct and reporting (SAGE)

Regulatory Reconnaissance #227 - 2 January 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 [email protected].