Regulatory Recon: EU Companies Hit With Big Fines for Delayed Generics (9 July 2014)

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In Focus: US

• Judge shuts down state’s ‘vague regulations’ on Zohydro (Boston Herald) (Law 360-$)
• Impact of FDA Advisory Committee Voting on FDA Approval Decisions for Drugs and Biologics (Reuters)
• Stakeholders Urge FDA To Proceed With Single-Page Medication Information (IHP-$)
• ONC panel backs Health IT Safety Center (Modern Healthcare-$)
• HIT stakeholders raise concerns with FDASIA framework (Fierce) (Gov HIT) (HIT News) (Modern Healthcare-$)
• FDA prepares to weigh risks of uterine fibroid removal tool (Reuters) (Fierce) (Modern Healthcare-$)
• Smith & Nephew Warning Letter Details Uncleared Product Modifications (Gray Sheet-$)

In Focus: International

• EU Fines Drug Producers for Delaying Cheaper Medicine (WSJ-$) (AP) (Bloomberg)
• New EU plan to fast-track next-generation drugs launches (Pharma Times)
• Ease regulations to cure drug industry antibiotic resistance, says RPS (In-Pharma)
• Indian Doctors Take Note of Industry's Regulatory Problems (Forbes)
• Indian firms must invest in compliance as USFDA ups enforcement, says S&P (In-Pharma)
• BMJ Hits Revised Treaty of Helsinki for Being too Weak (BMJ)
• CFDA finds defective condoms, catheters, IV sets (ECNS)

US: Pharmaceuticals and Biotechnology

• Judge shuts down state’s ‘vague regulations’ on Zohydro (Boston Herald) (Law 360-$)
• Impact of FDA Advisory Committee Voting on FDA Approval Decisions for Drugs and Biologics (Reuters)
• Stakeholders Urge FDA To Proceed With Single-Page Medication Information (IHP-$)
• AMA Urges FDA To Share Drug Trial Safety Data; PhRMA, BIO Rebuff Idea (IHP-$)
• Ranbaxy Pays $2.3M To Settle Generic Safety Suit (Law 360-$)
• Protein Sciences Receives Approval from FDA for 2014/15 Formulation of Flublok Influenza Vaccine (Press)
• Fix for trials: Patient engagement, EHRs, biomarkers, networks (SCRIP-$)
• FDA Approves Anacor Pharma's New Toenail Fungus Treatment (AP) (Reuters)
• ANDA Approval for Perrigo's Generic Advil Congestion Reflief Tablets (Press)
• FORUM Pharmaceuticals Inc. Appoints Christine Boisclair as Vice President, Regulatory Affairs (Press)

US: Pharmaceuticals and Biotechnology: Clinical Study Results, Filings and Designations

• Otonomy heads to the FDA after its ear treatment clears Phase III (Fierce)
• Celgene's would-be blockbuster fails in Phase III for spinal arthritis (Fierce) (Press)
• Boehringer's breakthrough leukaemia drug hits Ph II targets (Pharma Times) (BioCentury) (Fierce) (SCRIP-$) (Pharmafile)

US: Pharmaceuticals and Biotechnology: General

• Rapid Price Increases for Some Generic Drugs Catch Users by Surprise (NYTimes)
• As FDA regulations tighten, report says antimicrobial market headed for a crash (Fierce)
• Insurers Looking to Capitated Payment Models to Control Cancer Drug Costs (Wonkblog)
• Symbol Indicating OTC Safety For Pregnant Women Could Point To Sales Growth (Tan Sheet-$)
• Otonomy eyes US approval for ear drug (SCRIP-$)

US: Medical Devices

• ONC panel backs Health IT Safety Center (Modern Healthcare-$)
• HIT stakeholders raise concerns with FDASIA framework (Fierce) (Gov HIT) (HIT News) (Modern Healthcare-$)
• FDA prepares to weigh risks of uterine fibroid removal tool (Reuters) (Fierce) (Modern Healthcare-$)
• Smith & Nephew Warning Letter Details Uncleared Product Modifications (Gray Sheet-$)
• Stomach-draining obesity device headed for FDA submission in 2015 (Fierce)
• Take Control Of Your Medical Device's FDA Classification (MedDevice Online)
• Software as a Medical Device (PCM)
• Adoption of new surgical technology linked to complications (Reuters)
• NeuroMetrix wins FDA nod for over-the-counter chronic pain device (Mass Device)
• April 2014 PMA Approvals (FDA)
• Vascular Solutions, Inc. Issues Recall of Langston Dual Lumen Catheters (FDA)
• Study Explores Expanded Use For Edwards' And Medtronic's New Heart Valves (Forbes)

US: Assorted And Government

• FDA Press Releases – What They Say – First Half 2014 (EyeOnFDA)
• New Batch of FDA Warning Letters Posted (FDA)
• Foster Farms battles insurers over definition of 'recall' (Reuters)
• CBO Scores DEA Scheduling Bill Faorably (CBO)
• House passes chemical facility security bill (The Hill)

Europe

• EU Fines Drug Producers for Delaying Cheaper Medicine (WSJ-$) (AP) (Bloomberg)
• New EU plan to fast-track next-generation drugs launches (Pharma Times)
• Ease regulations to cure drug industry antibiotic resistance, says RPS (In-Pharma)
• Swissmedic approves Amitiza for opioid-induced constipation (Pharma Letter-$)
• Orphan Drug Designation Granted in Europe for A1M Pharma’s Treatment for Preeclampsia (Press)
• French pharma trade group teams up with police to counter fake medicine (Pharma Letter-$)

India

• Indian Doctors Take Note of Industry's Regulatory Problems (Forbes)
• Indian firms must invest in compliance as USFDA ups enforcement, says S&P (In-Pharma)
• Indian Regulator Swings Into Action With New Rules On Clinical Trials, Biosimilars And Banning Of Drugs (PharmAsia-$)
• India limits trials per investigator but finite expert pool a concern (SCRIP-$)
• No bills on health, pharma sectors to be discussed during ongoing Parliament session (PharmaBiz)

China

• CFDA finds defective condoms, catheters, IV sets (ECNS)
• China says GSK-linked trial being handled according to law (Reuters)

Canada

• The painkiller puzzle: How to solve Canada's growing opioid crisis (CBC)

Other International

• BMJ Hits Revised Treaty of Helsinki for Being too Weak (BMJ)
• COFEPRIS seizures demonstrate importance of proper medical device labeling in Mexico (Mass Device)
• In Memoriam: Nigeria's Professor Dora Akunyili (SafeMedicines)

Clinical Trials

• BMJ Hits Revised Treaty of Helsinki for Being too Weak (BMJ)
• AMA Urges FDA To Share Drug Trial Safety Data; PhRMA, BIO Rebuff Idea (IHP-$)
• Fix for trials: Patient engagement, EHRs, biomarkers, networks (SCRIP-$)
• Indian Regulator Swings Into Action With New Rules On Clinical Trials, Biosimilars And Banning Of Drugs (PharmAsia-$)
• India limits trials per investigator but finite expert pool a concern (SCRIP-$)

General Regulatory And Interesting Articles

• The Gardasil HPV Vaccine Doesn't Increase Blood Clot Risk (Forbes) (NPR)

Regulatory Reconnaissance #353 – 9 July 2014

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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