Regulatory Focus™ > News Articles > Regulatory Reconnaissance (11 March 2013)

Regulatory Reconnaissance (11 March 2013)

Posted 11 March 2013 | By Alexander Gaffney, RAC

Good morning and welcome to another edition of Regulatory Reconnaissance. This weekend saw a torrent of news come out of the American College of Cardiology's (ACC) conference. Among the biggest items of news: Merck's niacin doesn't work, and may actually be harmful to its users.

In the US, Sanofi says the US is probing it regarding Plavix disclosures to FDA, CBS says the situation at a pharmaceutical compounder was much worse than reported, the White House is switching its position on preemption, an FDA-run medical device pilot program reportedly failed, J&J loses a big court case, and a government attorney says prosecutions will hinge on patient benefit in wake of the Caronia decision.

Abroad, AbbVie is suing EMA over the transparency of clinical trials data, Eisai is 'appalled' at German regulators' reimbursement practices, the PRAC is still looking into the safety of contraceptives, India approves a new TB drug on a limited basis, and EMA releases a new guideline on advanced therapy medicinal products.

Five in Focus:

  1. Pharma group sues European regulator over data (Financial Times) (Reuters) (EurActiv)
  2. Eisai Is Simply 'Appalled' At German Regulators (Pharmalot)
  3. Off-Label Prosecutions Hinge On Patient Benefit, Government Attorneys Say (The Pink Sheet) ($)
  4. Investigation Finds NECC Was Blatantly Violating Compounding Rules (CBS) (CBS)
  5. Sanofi says U.S. probing Plavix disclosures to FDA (Reuters)


Sequester & Budget
  • Sanofi says U.S. probing Plavix disclosures to FDA (Reuters)
  • Investigation Finds NECC Was Blatantly Violating Compounding Rules (CBS) (CBS)
  • Compounding Oversight: Could Third-Party Inspection Solve The Problem? (The Pink Sheet) ($)
  • White House To Argue In Favor Of Preemption (Pharmalot)
  • Ranking Members Waxman, Pallone, and DeGette Request Hearing on Public Health Risks From Antibiotic-Resistant Bacteria (Congress)
  • Woodcock Interviewed on 'Change in Approach' to Drug Regulation, Including Breakthrough Submission Status and the use of Biomarkers (MendelSpod)
  • New Medication Guides Posted for Abilify Maintena, Stavzor. 12 Others Updated (FDA)
  • Bayer eyes wider use for Xarelto with new trials (Reuters) (Bayer) (Bayer)
  • Big Bucks, No Benefits with Many Drugs (Medpage Today)
  • Painkiller Abuse Hits New States (WSJ)
  • NYTimes Calls for Generic Drug Makers to be Held "Accountable" for Safety Issues Not Known to Branded Manufacturer (NYTimes)
  • Pfizer drops hepatitis C candidate filibuvir (PM Live)
Medical Devices
  • FDA Says Pilot On Standard Electronic Labeling For Devices "Didn't Work" (The Gray Sheet) ($)
  • J&J Must Pay $8.3 Million Over Defective Hip, Jury Says (Bloomberg) (Reuters) (The Guardian) (Pharmalot)
  • St. Jude eyes FDA approval with trial for stroke-stopping heart plug (Fierce Medical Devices)
  • Hauser's FDA Rx: The FDA needs an NTSB (Mass Device)
  • The 6 lines of code that could bring down a hospital (Mass Device)
  • Class I Recall for Macro Micro Subdural Electrodes Manufactured by Ad-Tech Medical (FDA)
  • Early-Stage Device Companies vs Biopharmas: Who Has It The Worst? One VC Argues Devices Do (Forbes)
  • Ford: Health sensors in car won't alert impending heart attacks (Mobihealth News)
  • Report: Boston Scientific issues alert on its lead-free S-ICD defibrillator (Mass Device)
  • Artis Q, Artis Q.zen Angiography Systems from Siemens FDA Approved (Medgadget)
  • Multiple incidents of low-reacting assay plates behind Class II recall of lyme disease kit (FDA)
  • Sorin's Isoline defibrillation leads distributed may have internal insulation breach (FDA)
  • The Medical Device Tax and Contract Manufacturers-Who Pays? (MDDI)
American College of Cardiology Conference News
  • Off-Label Prosecutions Hinge On Patient Benefit, Government Attorneys Say (The Pink Sheet) ($)
  • Former FDA Deputy Commissioner Comes out in Support of Medical Marijuana Bill (AP)
  • FDA's Counterfeit Detection Device in Running for DHHS's 'Most Innovative' Award (DHHS)
  • Highlights from the Fifth Annual Sentinel Initiative Public Workshop (Brookings)
  • SC bust seizes fake prescription drugs from India (AP)
  • New Rule Changes Requirements for Handling Hazardous Waste, Including Medical Waste (Federal Register)
  • FDA Scientists Think Canine Leishmaniasis Vaccine Could Prevent Spread in Humans as Well (FDA)
  • MedPAC: Rx Adherence Not Always a Savings (Medpage Today)
  • Insurers distance themselves from J&J counterfeit case (Securing Industry)
  • Request for Nominations of Candidates To Serve on the Advisory Committee on Immunization Practices (CDC)
  • Board of Scientific Counselors, Office of Public Health Preparedness and Response (BSC, OPHPR) (CDC)
  • New FTC chief vows online privacy push (The Hill)
  • CT Bill Would Require insurance Companies to Cover Products With Abuse-Deterrent Policies Before Non-Abuse Deterrent Generic Equivalents (CT)
  • Arkansas Bill Would Limit Use of Mifepristone (AR)
  • NY Legislation Would Change Requirements for Registration of Drug Wholesalers, Manufacturers (NY)
  • Donate Eggs For Research? California Bill Seeks To Compensate Women (Sacramento Bee)


  • Pharma group sues European regulator over data (Financial Times) (Reuters) (EurActiv)
  • Guideline on the risk-based approach according to annex I, part IV of Directive 2001/83/EC applied to Advanced therapy medicinal products (EMA)
  • Eisai Is Simply 'Appalled' At German Regulators (Pharmalot)
  • EMA's PRAC Says Review of Diane 35, Generics 'Ongoing' (EMA)
  • PRAC Starts Referral Process Against Nicotine Acid, Flupirtine, Domperidone, Kogenate Bayer and Helixate NexGen (EMA)
  • Big Pharma, Generics Activists Dispute Slows New TPP Agreement (PharmAsia News) ($)
  • India Government Approves Bedaquiline For Resistant TB On Fill-In Basis (PharmAsia News) ($)
  • WHO finds Syrian situation grim, drug shortages critical (Pharmalot)
  • Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 5-7 March 2013 (EMA)


  • Major Grocer to Label Foods With Gene-Modified Content (NYTimes)
  • Whooping cough vaccine protection wanes (Reuters)

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 or @AlecGaffney 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.

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