Regulatory Focus™ > News Articles > Regulatory Reconnaissance (4 April 2013)

Regulatory Reconnaissance (4 April 2013)

Posted 04 April 2013 | By Alexander Gaffney, RAC

Good morning and welcome to another edition of Regulatory Reconnaissance.

In the US, Pfizer remains stuck with a $142 million judgment over Neurontin, FDA warns consumers about several adulterated products, 'Business as usual' for FDA and the new China FDA, crooks pose as FDA agents, Tris Pharma wins approval for a new allergy drug, Mylan gets approval for a herpes ointment, Sun Pharma gets an approved ANDA for Azithromycin, GSK starts a PhIII trial for benlysta, Janssen's daratumumab gets fast-track status, Hitachi wins clearance for a medical CT scanner, Merck's Fosmax is back in the courts, more trouble for Durata ICD leads, and a methamphetamine addiction vaccine looks promising.

Abroad, other counties could follow India's lead when it comes to striking iterative patents, India looks to give innovative drug products an edge when it comes to price controls, Brazil's ANVISA looks to beef up international inspections, regulatory risks seen as looming in China, Canada's health minister wants help on Opioid control from the US, Korea strikes down a Pfizer challenge on Viagra patent, and a new UK learning guide wants to help doctors identify adverse events.

Plus: A possible AIDS vaccine emerges, a researcher says a cancer treatment has no side-effects, a potential therapy for prion disease, and an old drug offers new hope against Niemann-Pick disease.

Five in Focus

  1. Court upholds $142 million verdict against Pfizer over Neurontin (Reuters)
  2. Generic Suits Citing Bioequivalency Blocking By Brands Continue to Pile Up (FDA News) ($)
  3. 'Business as Usual' for FDA, China Counterpart After Reorganization (BNA)
  4. Crooks posing as FDA agents (WDAM)
  5. EU, Australia, Canada may follow India's Patent Law (Economic Times)


  • Meth Addiction Cure: UCLA Tests Ibudilast On Human Addicts (Huffington Post)
  • Court upholds $142 million verdict against Pfizer over Neurontin (Reuters)
  • Merck vax condemning pox to past (Fierce Vaccines)
  • Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee to Assess Endo Phrma's Aveed (testosterone undecanoate) (FDA)
  • Meeting: Peripheral and Central Nervous System Drugs Advisory Committee (FDA)
  • Florida Biosimilars Bill seeks to notify patients and doctors of changes to prescriptions (The Pharma Letter) ($)
  • Generic Suits Citing Bioequivalency Blocking By Brands Continue to Pile Up (FDA News) ($)
  • Pfizer partners with hospital to research medicines for children (PMLive) (Pfizer)
  • An MS Drug Takes a Feisty Advertising Approach Aimed at Younger Patients (NYTimes)
  • Janssen and Genmab's daratumumab fast-tracked by US FDA (The Pharma Letter) ($)
  • GlaxoSmithKline announces start of phase III study of Benlysta (belimumab ) in patients with vasculitis (GSK)
  • J&J to take anti-wrinkle fight to Botox with new drug development (Cosmetics Design Europe)
  • Drug shortages spur debate over role of compounding pharmacies (Modern Healthcare)
  • Sun Pharma Obtains ANDA Approval (#090923) for its Injectable Azithromycin (FDA)
  • FDA approves new oral-suspension antihistamine (Drug Store News)
  • FDA approves Mylan genital herpes ointment (Drug Store News)
  • FDA approves new Tris Pharma allergy drug for children (Drug Store News)
  • FDA finds another batch of 'natural' sex enhancement products that aren't (NBC News) (FDA) (FDA) (FDA)
  • CVS pays $11 million to settle prescription drug case (The Hill)
  • The Survey Says: Ariad's Leukemia Drug Is Toxic (The Street)
  • Maine Legislation Would Act to Ensure the Safety of Compounded Drugs (Scout)
  • Preemption: Fifth and Sixth Circuits split on viability of "failure to update" claims against generic drug manufacturers (Lexology)
Medical Devices
  • Report cites inside-out abrasion of Durata lead (Cardiovascular Business)
  • Merck's Fosmax on Trial Again After First Case Halted (Bloomberg)
  • Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee: Notice of Postponement of Meeting (FDA)
  • Stryker Sees Double Trouble from FDA (MDDI)
  • Doc who designed DePuy's metal hip tells jury he wouldn't implant the device today (Mass Device)
  • FDA OKs Hitachi Medical CT scanner (Mass Device) (Fierce Medical Devices)
  • First-to-File Patent Rule Threatens Medtech R&D (MDDI)
  • LensAR lands another FDA clearance for cataract laser surgery (Mass Device)
  • Animas Issues Class 1 Recall Over its Insulin Infusion Pump (FDA)
  • 'Business as Usual' for FDA, China Counterpart After Reorganization (BNA)
  • Publication bias found in emerging CVD biomarker research (Cardiology Today)
  • Crooks posing as FDA agents (WDAM)
  • Companies Race to Promote New Genetic Screen for Down Syndrome; Worries About Patient Confusion (WSJ)
  • Implementation of the FDA Food Safety Modernization Act Provision Requiring FDA To Establish Pilot Projects and Submit a Report to Congress for the Improvement of Tracking and Tracing of Food; Extension of Comment Period (FDA)
  • Homeopathic regulation diluted until no substance left (Science-Based Medicine)
  • Biotech startup sees microchips as a human's best friend in drug development, raises $9.2M (Med City News)
  • Enforcement Report - Week of April 3, 2013 (FDA)
  • Advisory Council Meeting on Alzheimer's Research, Care, and Services (DHHS)
  • Strike Out! FSMA Whistleblowers Bat Zero in FY2011-12 (Food Product Design)
  • Caffeine Controversy Percolates, CRN Stimulates a Label Change (Natural Products Insider) (The Hill)
  • Incremental Innovation Series: Focus on Rheumatoid Arthritis (PhRMA)
  • Justice Department Dismantles Fake Online Pharmacy Conspiracies & Convicts 9 (Safe Medicines)
  • USPSTF recommends BRCA-related testing for some (BioCentury)
Warning Letters
  • (Dietary Supplements) Healthy People Co. for Misbranding, Unapproved New Drugs (FDA)
  • (IRB) Agnesian Healthcare for General IRB Deficiencies (FDA)
  • (Medical Device) Acclarent, Inc for Misbranding, Reporting (FDA)
  • (Medical Device) Feel Tech for Adulteration, QSR (FDA)
Government and Budget
  • Sequestration Stupidity Is Genetic, Hitting Front-Line Medical Research (Huffington Post)
  • What Obama's brain map tells us about the state of U.S. science (Washington Post)
  • Biopharma Embraces Obama "BRAIN" Plan (Scrip Intelligence)
  • Sequester Cuts to Science Slow Biomedical Research (Scientific American)
  • Grassley questions profits from discount drug program (The Hill)
  • Reminder: President's FY2014 Budget Due out Around 8-10 April 2013
Meetings and Events This Week
  • 4 April 2013: Hamburg to Deliver Keynote to 2013 National Rx Drug Abuse Summit (NRxDA Summit)
  • 4 April 2013: NIH's Francis Collins to Appear on Stephen Colbert's 'The Colbert Report' (Colbert Nation)
  • 5 April 2013: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting Announcement (FDA) (Postponed)
  • 8 April 2013: Ophthalmic Devices Panel of the Medical Devices Advisory Committee Meeting Announcement (FDA)
  • 25 April 2013: Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Shortened to a Single Day (FDA)
  • Other Upcoming FDA Advisory Committee Meetings and Topics (Eye on FDA)


  • EU, Australia, Canada may follow India's Patent Law (Economic Times)
  • Innovative drugs to be allowed to skip price control for 5 years (Economic Times)
  • Brazil's ANVISA to beef up international inspections (the pharma letter)
  • Rising Labor Cost, Regulatory Uncertainty Top Risks For Multinationals In China - AmCham Survey (PharmAsia News)
  • Canada's Aglukkaq asks for US help to control oxycodone (CMAJ)
  • Korean Court Dismisses Pfizer's Call For Protection Of Sildenafil Design (PharmAsia News) ($)
  • UK: New learning guide will help doctors recognise and report drug side effects (MHRA)
  • Written Confirmations - How is the EU pharmaceutical Industry dealing with that? (ECA)
  • Pharma trade deals costing Australia "billions" (Pharma Times)
  • Australia issues warning on American Medical Systems' urinary control systems (Mass Device)
  • Australia: Draft compositional guideline: Calcified Lithothamnion tophiforme (TGA)
  • Australia: Compositional guideline: Calcified Lithothamnion tophiforme (TGA)
  • Roche launches new test for diagnosis and monitoring of thyroid cancer (Roche)
  • India's Haryana FDA files case against kingpin in kidney racket (Times of India)
  • AbbVie's Humira cleared in EU for polyarticular juvenile idiopathic arthritis (The Pharma Letter) ($)

General Regulatory and Interesting Articles

  • Why Regulatory Intelligence Is More Important Than Ever (Pharmaceutical Online)
  • Possible Path to Vaccine for AIDS Is Suggested (NYTimes)
  • French researchers cast doubt on chemo biomarker's viability (Fierce Biomarkers)
  • Breakthrough cancer-killing treatment has no side-effects (EurekAlert)
  • Scientists identify first potentially effective therapy for human prion disease (EurekAlert)
  • Do Erectile Disfunction Drugs Cause more STDs? (Healthcare Economist)
  • What's crazy? Sexual fetishes spur psychiatric manual controversy (CBS)
  • Side Effects Prompt Patients To Stop Cholesterol Drugs (NYTimes)
  • Experimental sleep drug may cause fewer side effects: Merck study (Reuters)
  • Old Drug Offers New Hope Against Rare, Deadly Childhood Disease​ (Science Daily)

Regulatory Reconnaissance #38 - 4 April 2013

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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Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @AlecGaffney or send him an email at

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