Regulatory Focus™ > News Articles > Regulatory Reconnaissance (15 April 2013)

Regulatory Reconnaissance (15 April 2013)

Posted 15 April 2013 | By Alexander Gaffney, RAC

Good morning and welcome to another edition of Regulatory Reconnaissance. The must-follow event of the day is by all accounts the A.M.P. vs Myriadcase to be heard before the Supreme Court today. At issue: May human genes be patented?

In the US, FDA plans to revisit a study of Avandia's cardiovascular risks, FDA's Richard Pazdur reminds industry that accelerated approvals may also result in withdrawals, FDA loses its top IT official, OxyContin's patent expires on 16 April, a new report shows that state regulators know next to nothing about pharmaceutical compounders, Taro gets FDA approval for its psoriasis spray NDA, FDA argues that its GDUFA goals won't be met without full funding for its White Oak campus, PhRMA gets a new chairman, a new partnership will subject devices to private-sector comparative effectiveness research, Boston Scientific launches the Precision Spectra spinal cord stimulator device, Stryker issues a Class 1 Recall for its ShapeMatch cutting guides, Eisai's CEO calls DEA's scheduling process a "black hole," and a new GOP bill targets "sue and settle" regulations.

Abroad, India's supreme court calls for Glenmark to respond to a patent challenge by 22 May, France's regulator says Celgene's thalidomide is associated with a potential increased risk of secondary cancer, an EMA committee wants curbs on several drugs, a new pharmacovigilance guideline established considerations for vaccines, India plans to set up warehouses to assist small companies with exports, China looks to spur device innovation and shun imports, Vietnam releases new regulations for its pharmaceutical industry, Saudi Arabia issues warnings about social media promotion of drugs, Switzerland forges a pricing and access pact, and Israel denies drug shortage rumors.

Plus: Could stem cell research lead to new drug safety testing methods?

Five in Focus

  1. FDA to Reassess Safety Risk Evidence for Avandia (WSJ) (Forbes) (Reuters) (Med Page Today) (BioCentury) (SCRIP Intelligence)
  2. FDA's Richard Pazdur: FDA "Regulatory Flexibility" On Accelerated Approval Must Result In Some Withdrawals (The Pink Sheet) ($)
  3. Eric Perakslis leaves top IT job at FDA (Fierce Biotech IT) (BioCentury)
  4. France Says Celgene's Thalidomide Associated With Potential Increase in Risk of Secondary Cancer (ANSM)
  5. Drug patent row: Delhi High Court seeks Glenmark's response by May 22 (India Times)


  • FDA to Reassess Safety Risk Evidence for Avandia (WSJ) (Forbes) (Reuters) (Med Page Today) (BioCentury) (SCRIP Intelligence)
  • FDA's Richard Pazdur: FDA "Regulatory Flexibility" On Accelerated Approval Must Result In Some Withdrawals (The Pink Sheet) ($)
  • FDA Schedules Hearing on Avandia NDA, Looks to Possibly Restrict Usage (FDA)
  • First OxyContin Patents Expires Tuesday, Putting Pressure on FDA to Act Quickly (WSJ) (The Pink Sheet) ($)
  • Report: Compounding pharmacies go untracked (Washington Post)
  • Summary: 2013 FDA Pharmacy Inspection Assignment (FDA) (FDA Law Blog)
  • FDA OK for Taro's psoriasis spray (Pharma Times)
  • FDA Approves ANDAs for Lupin's Daysee (Ethinyl Estradiol Levonorgestrel), Mylan's Prednisolone sodium phosphate, and Actavis's Oxycodone/Acetaminophen (FDA)
  • GDUFA Commitments Won't Be Met If Congress Nixes White Oak Funding (The Pink Sheet) ($)
  • FDA's Neoadjuvant Breast Cancer Accelerated Approval Pathway Starts To Take Shape (The Pink Sheet) ($)
  • New Medical, Statistical and Clinical Pharmacology Review of Janssen's Oxybutynin chloride - Ditropan XL Pediatric Studies Posted (FDA)
  • Meningitis outbreak: FDA, compounders clash over access (The Tennessean)
  • Janssen's experimental drug targeting 3 types of cancers gets FDA boost (Star Ledger)
  • Calls To National Poison Data System About Exposure To OxyContin, Single-entity Oxycodone Drugs, Heroin (The Pink Sheet) ($)
  • FDA Releases Updated Orange Book (FDA)
  • Obama budget is a disaster for drugmakers (Washington Post)
  • Study: Higher US Branded Drug Prices And Spending Compared To Other Countries May Stem Partly From Quick Uptake Of New Drugs (Health Affairs)
  • PhRMA names Hugin chairman (BioCentury)
  • PhRMA Members Spent $48.5 Billion On R&D In 2012 (The Pink Sheet) ($)
  • Otsuka's New Drug Application For Tolvaptan, The Investigational Compound For Autosomal Dominant Polycystic Kidney Disease (ADPKD), Acceped For Review By The Us Food And Drug Administration (FDA) (Otsuka) (BioCentury) (PharmaTimes)
  • FDA to review BTG's Varisolve (BioCentury)
  • Early Signs Of Harmful Drug Reactions Uncovered By Mining Of Clinical Notes (Medical News Today)
  • FDA approves Lupin generic contraceptive (Drug Store News) (India Times)
  • Warner Chilcott, PLC Receives FDA Approval of DORYX Delayed-Release 200 Mg Tablets (BioSpace)
  • It Takes An Abuser To Find Abuse Potential, Janssen Tells FDA (The Pink Sheet) ($)
  • Draft Regulations On Certifications Within California ePedigrees (RxTrace)
  • Elderly Patients Routinely Prescribed Risky Drugs (NYTimes)
Medical Devices
  • Healthcare Heavyweights Team To Compare Medical Devices (Information Week) (The Gray Sheet)
  • Boston Scientific Launches Precision Spectra Spinal Cord Stimulator System In The United States (Boston Scientific) (MedGadget)
  • Intuitive Surgical Issues Class 2 Recall for Da Vinci Surgical System, Citing Revised Instructions (FDA)
  • National Advertising Division recommends B+L make changes to advertorial claims (Drug Store News)
  • Teleflex Receives FDA 510(k) Clearance for ISO-Gard Mask with ClearAir Technology (Infection Control Today)
  • Stryker Issues Class 1 Recall over ShapeMatch Cutting Guides (FDA)
  • Lifescan Issues Class 1 Recall Over OneTouch Verio IQ Blood Glucose Monitoring System (FDA)
  • Medtronic launches FDA-targeted study for pain devices (Fierce Medical Devices)
  • Eric Perakslis leaves top IT job at FDA (Fierce Biotech IT) (BioCentury)
  • SCOTUS to Consider Petition of GSK v. Humana Medical Plans (Scotus Blog) (Philly Pharma)
  • Eisai CEO: DEA Scheduling Process a "Black Hole" (The Pink Sheet) ($)
  • How Realistic is GSK's Plan for Data Transparency? (BioCenturyTV)
  • The Curious Case of Trent Arsenault: Questioning FDA Regulatory Authority Over Private Sperm Donation (Cause of Action)
  • Energy and Commerce and Appropriations Leaders Examine Reports of Excessive PR Spending at NIH (E&C)
Government and Budget
Upcoming Meetings and Events
  • 15 April 2013: Supreme Court Hears Case Between the Association for Molecular Pathology v. Myriad Genetics, Inc on Whether Genes May be Patented (SCOTUS Blog)
  • 17 April 2013: Cellular, Tissue and Gene Therapies Advisory Committee Meeting (FDA)
  • 17 April 2013: Pulmonary-Allergy Drugs Advisory Committee Meeting Announcement (FDA)
  • 18 April 2013: Joint Meeting of the Advisory Committee for Reproductive Health Drugs and Drug Safety and Risk Management Advisory Committee (FDA)
  • 18 April 2013: A Financial Review of the Department of Health and Human Services and Its FY 2014 Budget (E&C)
  • 19 April 2013: Senate Appropriations Subcommittee on Agriculture and FDA to Hold Hearing, Hamburg Will Testify (Appropriations)
  • 26 April 2013: Senate Appropriations Committee to Markup FDA Bill (Appropriations)
  • Other Upcoming FDA Advisory Committee Meetings and Topics (Eye on FDA)


  • Drug patent row: Delhi High Court seeks Glenmark's response by May 22 (India Times)
  • France Says Celgene's Thalidomide Associated With Potential Increase in Risk of Secondary Cancer (ANSM)
  • EMA Committee calls for curbs on Protelos/Osseor, tetrazepam suspension (The Pharma Letter) ($) (PMLive) (Pharma Times)
  • Guideline on good pharmacovigilance practices (GVP): Product-or population-specific considerations I: Vaccines for prophylaxis against infectious diseases (EMA)
  • India's Ruling on a Novartis Drug: 2 Perspectives (NYTimes)
  • Indian Govt plans to set up warehouses abroad to help SME exporters (Pharma Biz)
  • International Regulators Forum Adds To Ambitious Policy Agenda (The Gray Sheet) ($)
  • China Offers Green Channel To Spur Device Innovation, Import Replacement (The Gray Sheet) ($)
  • Norway's Gro Ramsten Wesenberg to Retire (Twitter)
  • Israel's Health minister denies scarcity of medications (Jerusalem Post)
  • Russia may impose new GMP requirements for drug imports (The Pharma Letter) ($)
  • Novartis has backup for false protection against Voltaren counterfeits (SCRIP Intelligence)
  • Saudi FDA Issues Warning on Use of Social Media (Arab News) (8 April)
  • New regulations to manage Vietnam pharmaceutical industry (The Pharma Letter) ($)
  • Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 9-11 April 2013 (EMA)
  • Switzerland and pharma forge pricing and access pact (PMLive)
  • EU agencies consider phenylbutazone detected in horsemeat of low concern for consumers; recommend improved horse traceability and monitoring of veterinary medicinal residues (EMA)
  • Emerging Markets Regulatory Tracker: Brazil, India (PharmAsia News) ($)
  • Merck Serono to finance the launch of the EspeRare Foundation (Pharma News EU)

General Regulatory and Interesting Articles

  • Pfizer's Quality by Design Approach to Trial Management (Pharmaceutical Executive)
  • Safer Human Testing Of Drugs With New Cutting-Edge Cell Research (Medical News Today)
  • Looking To Nature For Antibiotic Inspirations (NPR)
  • GE gets lost in 'The Matrix' with new ad for connected hospitals starring Hugo Weaving (The Verge)
  • New Use For Safety Reflector Technology In Detecting Bioterror Threats (Medical News Today)

Regulatory Reconnaissance #45 - 15 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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