Regulatory Focus™ > News Articles > Regulatory Reconnaissance (6 March 2013)

Regulatory Reconnaissance (6 March 2013)

Posted 06 March 2013 | By Alexander Gaffney, RAC

Good morning and welcome to another edition of Regulatory Reconnaissance. From the sequester to the "snowquester" storm now bearing down on Washington, DC, it's been a messy week for just about everything in the Nation's capital.

In the US, DHHS is still figuring out furloughs, an FDA panel has voted against calcitonin salmon drugs, an already-messy Roche case gets messier, a storm delays a GSK drug's panel hearing, Pfizer's Celebrex gets a patent extension, Par Pharmaceuticals will pay $45M for off-label promotion, BioCentury takes a hard look at Amylin for withholding data, newly-approved drug Kadcyla now has an FDA-approved  companion Dx device, new warning letters, and a new government report says DHHS-and perhaps FDA-remains vulnerable to hackers and other security risks.

Abroad, China could make a new approval channel to recognize drugs already approved elsewhere in the world, EMA is out with new guidelines on interferon beta biosimilars and r-hFSH, ABPI is out with new pharmacovigilance guidance, Medtronic gets a CE marking for its Quadripolar leads, TGA issues warning out a GSK vaccine, and the February edition of the Eudralex for pharmaceutical products is now out.

Five in Focus:

  1. FDA panel narrowly votes against benefits of decades-old bone strengthening drug (AP) (Reuters) (Med Page Today)($NVS)
  2. Pfizer Painkiller Gets Longer Patent Protection (WSJ) (Pfizer) (Reuters) ($PFE)
  3. Par Pharmaceutical Admits Misbranding AIDS Appetite Medicine , Will Pay $45M (Reuters) (Bloomberg) (WSJ) (The Pink Sheet) ($PRX)
  4. Medtronic pays $84M to settle Edwards TAVI patent infringement (Mass Device) ($MDT, $EW)
  5. Special Approval Channel In China For Overseas Certified Drugs Soon (PharmAsia News) ($)


Sequester & Budget

  • HHS Uncertain Whether Staff Will Face Furloughs Due To Sequestration (Huffington Post)
  • House to skip town because of storm (The Hill)


  • FDA panel narrowly votes against benefits of decades-old bone strengthening drug (AP) (Reuters) (Med Page Today)($NVS)
  • Roche Slammed By Judge For Recusal Request (Pharmalot) ($RHHBY)
  • San Francisco OKs Voter Measure On Drug Pricing (Pharmalot)
  • FDA postpones panel for Glaxo's COPD drug as snowstorm advances (Reuters) (BioCentury)($GSK)
  • Public Citizen to FDA: Nasal Calcitonin Not Effective for Osteoporosis, Linked to Increased Cancer Risk (Public Citizen) ($NVS)
  • Pfizer Painkiller Gets Longer Patent Protection (WSJ) (Pfizer) (Reuters) ($PFE)
  • Petitions Pour in Regarding FTC v. Actavis/Watson Pay-for-Delay Case (American Bar Association) ($BAY, $PRX, $ACT, $RANBAXY, $MRK, $SHPG, $SOLB)
  • Two Ex-FDA Commissioners Say Generic Makers Don't Get Free Pass on State Suits (FDA News) ($)
  • Par Pharmaceutical Admits Misbranding AIDS Appetite Medicine , Will Pay $45M (Reuters) (Bloomberg) (WSJ) (The Pink Sheet) ($PRX)
  • FDA Delayed Bydureon Approval After Feeling Amylin Had 'Deceptively Withheld Data' (BioCentury) ($) (Drug Wonks) ($AMLN)
  • GSK, Hospira litigation highlights danger in contract manufacturing (Fierce Pharma) (Fierce Pharma Manufacturing) ($GSK, $HSP)
  • Nuvo/Mallinckrodt's Pennsaid Setback Starts Clock On Generic Launch (The Pink Sheet Daily) ($)
  • Biosimilars: Is the Market Getting Too Much Attention? (Outsourcing Pharma)
  • Lilly Sets Date for 2013 Diabetes Pipeline Update to the Media and Investment Community (Lilly) ($LLY)
  • A Bright Future for Orphan Disease Indications (BIO)
  • Op-ed: Fed 'reform' puts bio at risk (Boston Herald)
  • Indiana Legislation Would Institute Expansion of Electronic Database Monitoring for Opioids (SCOUT)
  • Ranbaxy to market antidepressant drug (Drug Store News) ($RANBAXY, $PFE)
  • Actavis seeks approval for testosterone-replacement gel (Drug Store News) ($ACT, $ENDP
  • Agila gets FDA nod for Zoledronic Acid Injection (BioSpectrum) ($MYL)
  • Oklahoma Bill Would Up-Schedule Certain Methamphetamine Substances to Schedules I and II (SCOUT)
  • Minnesota Bill Would Affect Regulation of Pharmaceutical Compounders (SCOUT)

Medical Devices

  • Medtronic pays $84M to settle Edwards TAVI patent infringement (Mass Device) ($MDT, $EW)
  • Boston Scientific's Study at Heart Meeting Under Review (Bloomberg) ($BSX)
  • Dako wins companion Dx approval for Roche's Kadcyla (Fierce Medical Devices) ($RHHBY)
  • FDA approves new Roche test to evaluate response to hepatitis C therapy (Roche) ($ROG)
  • Updated: Data Standards and Terminology Standards for Information Submitted to CDRH (FDA)
  • Two Organizations Partner to Strengthen Benchmarking for Sterilization Community (AAMI)
  • ArthroCare lands FDA win for SpeedLock HIP implant (Mass Device) ($ARTC)
  • Arkansas Law Would Require Prior Approval for Medical Devices (SCOUT)
  • Patients Not Always Told About CT Risks (Med Page Today)

Warning Letters

  • (Medical Device)CryoLife for adulteration, CGMP deficiencies, uninvestigated deficiencies leading to patient death (FDA)
  • (Medical Device) TOADS, LLC for unapproved devices, adulteration under QSR, CAPA, out-of-specification devices (FDA)


  • FDA: Help Shape the Future of Health IT (FDA Voice)
  • Hamburg Sits Down to Talk About Health Fraud (FDA Voice)
  • Government Avoids Another Caronia-Like Decision, Perhaps by Luck (FDA Law Blog)
  • Experts: Bill to give Congress power over regulations is constitutional (The Hill)
  • Importance of a Drug's "Risk-Benefit" Profile Eludes Former FDA Commissioner (Forbes)
  • Often A Health Care Laggard, U.S. Shines In Cancer Treatment (NPR)
  • Whitepaper: Adaptive Trial Designs to Advance Oncology Research (PPDI)
  • Update on the Implementation of the National Strategy for Global Supply Chain Security Lauds Pharma's Commitment to Medical Countermeasure Development (White House)
  • Department of Health and Human Services-FDA's Parent Agency-Remains Vulnerable to Hackers, Says New Report (White House) (Federal Times)
  • Notice of Diabetes Mellitus Interagency Coordinating Committee Meeting (NIH)
  • Senators encourage GAO to investigate ways to collaborate on prescription drug abuse (Drug Store News)
  • Report: Gaps in Oversight of Conflicts of Interest in Medicare Prescription Drug Decisions (GAO)
  • IOM Workshop: Accelerating Therapeutic Development for Nervous System Disorders towards First-in-Human Trials (IOM)
  • CDC Says Drug-Resistant Bacteria on the Rise. Will GAIN Pathway be Enough? (UPI) (Reuters)
  • NSF responds to Beehive Botanicals warning letter situation (Nutra Ingredients USA)
  • A Clinical Trials System for the 21st Century (Faster Cures)
  • Abbott Rep Among Those Named to CBP Trade Advisory Group (CBP) ($ABT)
  • Michigan Secretly Collects Data About People Taking HIV Tests To Build Criminal Cases Against Them (Think Progress)
  • Minnesota government won't buy triclosan-based antibacterial products (Star Tribune)
  • Recently published cost-utility studies (CEA Registry Blog)
  • Dealing With the Foreign Corrupt Practices Act (NYTimes Dealbook) ($PFE)
  • JAMA journal quietly replaces diabetes drug commentary after learning co-author is working for drugmaker (Retraction Watch) ($BMS)
  • Vitamin C Claims Preempted (Drug and Device Law)
  • Weight loss simulator, hand-held counterfeit drug detector among HHS' best innovations (Med City News)


  • Special Approval Channel In China For Overseas Certified Drugs Soon (PharmAsia News) ($)
  • Guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant human follicle stimulating hormone (r-hFSH) (EMA)
  • Guideline on Similar Biological Medicinal Products Containing Interferon Beta (EMA)
  • ABPI publishes guidance for companies on pharmacovigilance for company employees (ABPI)
  • SFDA Aims to Stimulate R&D, Accelerate Approvals and Improve Distribution Practices (In-Pharma Technologist)
  • China's New Good Supply Practices Regs Require Electronic Barcodes; Raise Bar To Entry (Pharm Asia News) ($)
  • Medtronic Announces CE Mark and European Launch of Attain Performa Portfolio of Quadripolar Leads (Medtronic) ($MDT)
  • Data on antimicrobial consumption from EU/EEA countries now available from the ESAC-Net interactive database (ECDC)
  • Report Outlines What EU-Wide Network on HTA Should Look Like (EUnetHTA)
  • Celgene, Prospensa, Genzyme Recognized by EU Rare Disease Group (EURODIS) ($CELG, $GENZ)
  • Japan readies guidelines for Sequenom prenatal Down syndrome Dx (Fierce Medical Devices) ($SQNM)
  • EU consumer groups update nano silver products database (Cosmetics Design Europe)
  • Australian Regulators Issue Hazard Alert for Isoline Defibrillation Leads (TGA) ($SRN)
  • GSK's Fluarix Flu Vaccine Experiences 'Extremely Rare' Manufacturing Defect, Say Aussie Regulators (TGA) ($SK)
  • Pharma products being smuggled outside India are misused: International Narcotics Control Board (Economic Times)
  • Thalomid is not an innovative drug eligible for Canadian data protection (Lexology) ($CELG)
  • Ex-China Official Says Firms Forced to Fix Vitamin Prices (Bloomberg)
  • EudraLex V27 - February 2013 (EC)
  • REGULATION (EU) No 187/2013 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance ethylene (EURLex)
  • REGULATION (EU) No 190/2013 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance sodium hypochlorite (EURlex)


  • What are the Limits of GSK and Roche's Respective Pledges for Clinical Data Transparency? (BMJ) ($GSK, $ROG)
  • Regulation of Research on Human Subjects: Academic Freedom and the Institutional Review Board (American Association of University Professors)
  • Can Weather Affect Mail Order Drugs? (NYTimes)
  • Assume the Existence of a Sentient Medical Device-Who (or What) Assumes Liability if it Causes Harm? (Washington Post)
  • Novartis CEO: The Age Of Massive Blockbuster Drugs Is Over (Business Insider)
  • Insect Wings Shred Bacteria to Pieces (Scientific American)
  • Grotesque Mummy Head Reveals Advanced Medieval Science (Scientific American)
  • Advances in Life Expectancy Have Made 72 the New 30 (CNBC)
  • Using Routine Surveillance Data to Estimate the Epidemic Potential of Emerging Zoonoses: Application to the Emergence of US Swine Origin Influenza A H3N2v Virus (PLoS)

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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