Regulatory Focus™ > News Articles > Regulatory Reconnaissance (16 April 2013)

Regulatory Reconnaissance (16 April 2013)

Posted 16 April 2013 | By Alexander Gaffney, RAC

Good morning and welcome to another edition of Regulatory Reconnaissance. RAPS' thoughts are with our Boston-area colleagues today. Stay safe; Stay strong.

In the US, Supreme Court justices indicated they might favor a nuanced ruling on genetic patents that limits what can be patented, a key legislator threatens FDA with "consequences" if it doesn't limit generic opioids, an investigation shows that FDA has let drugs approved on the basis of fraudulent research remain on the market, drug manufacturers use REMS to limit generic competition, FDA's Tom Abrams says social media guidance is coming, Republicans shut down attempt to bring compounding industry before hearing, Takeda accused of hiding Actos safety data, GSK's lung drug Breo gets a boost from FDA, FDA seeks more data on Sarepta muscular dystrophy drug, regulators look to natural disasters to protect device supply chain, and the Supreme Court allows a provider to sue GSK for Avandia-related expenses.

Abroad, CDSCO says it will prioritize approval of new drugs with impact on India, regulators put new focus on medical software and apps, an Indian drugmaker's license is suspended over a fake antibiotic, ANZTPA launches a new recall portal, Spain and Italy lose in a bid to launch a unified patent system, the Economic Times argues that the Novartis patent case is the least of India's worries, IQWiG backs Zytiga for an additional indication, the European Commission issues a revised module on medicines applications, and MHRA holds off on opening an office in India.

Plus: Advances in lab-grown organs reach a new milestone-functional transplantation.

Five in Focus

  1. U.S. justices wary of wide human gene patent ruling (Transcript) (Bloomberg) (Reuters) (Philly Pharma) (Scotus Blog) (Scotus Blog) (Scotus Blog) (SCRIP Intelligence) (The Pink Sheet) (NYTimes) (WSJ) (NPR) (Med Page Today) (BioCentury) (Pharma Times)
  2. Legislator in Charge of FDA Budget Says Agency Will Face "Consequences" if it Doesn't Restrict Generic Opioids (UPI)
  3. FDA Let Drugs Approved on Fraudulent Research Stay on the Market (ProPublica)
  4. CDSCO to give priority to approval of new drugs having impact on public health (PharmaBiz)
  5. FDA's Abrams: That Long-Awaited Social Media Guidance Is Coming (Pharmalot) (Pharma Marketing Blog)


Medical Devices
  • FDA advisors look to Hurricane Katrina, Japanese tsunami for lessons in protecting medtech systems (Mass Device)
  • Carefusion Issues Class 1 Recall for Alaris PC Unit for Communication Software Errors (FDA)
  • FDA Guidance Lays Groundwork for Generic Albuterol Inhalers (FDA News) ($)
  • EPGL Medical Sciences Among First Device Makers to Use Google Glass (MDDI)
  • The story of a stent: How Medtronic's Resolute Integrity won FDA approval for diabetics (Mass Device)
  • FDA clears Luminex's Dx system for new GI test (Fierce Medical Devices)
  • Boston Scientific Begins Clinical Trial To Evaluate New Pacing System in MRI Environment (Boston Scientific)
  • Luminex testing device gets FDA clearance (Austin Business Journal)
  • Another Blood Glucose Meter Recall, This time Roche's Accu-Chek Inform II System bar code scanner (FDA)
  • February 2013 PMA Approvals (FDA)
  • FDA's Abrams: That Long-Awaited Social Media Guidance Is Coming (Pharmalot) (Pharma Marketing Blog)
  • Medicare Will Often Cover Costly Research-Related Injuries (FDA News) ($)
  • FTC Annual Report Highlights Commission Focus on Health-Related Advertising (FDA Law Blog)
  • UNPA: 'DMAA shows DSHEA process has worked'. USADA, ABC, NPA, CRN also respond to FDA stance (Nutra Ingredients USA)
  • Supreme Court Denies Certiorari; Provider Can Sue For Avandia-Related Expenses (Lexis Nexis)
  • 11th Circ. Revives FTC False Ad Claim Over Supplements (Law 360) ($)
  • PEPFAR: Per-Patient Costs Have Declined Substantially, but Better Cost Data Would Help Efforts to Expand Treatment (GAO)
  • Joint Biomedical Laboratory Research and Development and Clinical Science Research and Development Services Scientific Merit Review Board, Notice of Meetings (Veterans Affairs)
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)


  • CDSCO to give priority to approval of new drugs having impact on public health (PharmaBiz)
  • International regulators focus on medical software, including apps (Mobi Health News)
  • Indian drugmaker's license suspended over fake antibiotic (Securing Industry)
  • MHRA not to open Indian office but prefers sending expert inspectors: Gerald Heddell (PharmaBiz)
  • State drug regulators demand CDSCO to adopt common training module for all drug officials (PharmaBiz)
  • CDSCO Launches Web Page for Ethics Committees (CDSCO)
  • EC Issues 10th Revision of Module on Administrative Data That Needs to be Included on Medicines Application Forms (EC)
  • Australia/New Zealand's ANZTPA Launches Recall Portal (ANZTPA)
  • Spain, Italy Lose EU Court Appeal Over Patent System Adoption (Bloomberg)
  • IQWiG backs Zytiga for additional indication (BioCentury)
  • AstraZeneca signs cancer biomarkers discovery deal (PMLive)
  • Economic Times: Novartis patent verdict not a problem, other issues pose risks to Indian pharma innovation (India Times)

General Regulatory and Interesting Articles

Regulatory Reconnaissance #46 - 16 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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