Regulatory Recon: Back From Vacation, Back to Regulation (28 May 2015)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. We're back from a brief vacation hiatus. Today's Regulatory Recon includes all the major stories you might have missed between 23 May and today.

In Focus: US

• SCOTUS Declines Challenge to Alameda County Rx Drug Disposal Law (CA Healthline) (NPR) (Pink Sheet-$)
• Actavis barred from pulling older Alzheimer's drug (Reuters) (WSJ-$)
• FDA gives more time for electronic safety reporting (SCRIP-$) (Pink Sheet-$) (FDA)
• FDA AdComm to Discuss Misuse, Abuse of Oxycontin (FDA)
• Cephalon To Pay $1.2B To End FTC Pay-For-Delay Suit (Law 360-$) (Reuters)
• FDA Wants to Know Whether Spouses Influence how Drug Ads are Perceived (Pharmalot) (FDA)
• Biosimilar Naming Dilemma: If FDA Requires Suffixes, Do Reference Products Need Them, Too? (Pink Sheet-$)
• New bill seeks to spur FDA to form clearer social media rules (MM&M)
• FBI investigating medical device that spread cancer in women (CBS) (WSJ-$) (NYTimes)
• Researchers oppose unvalidated gene panel tests for cancer links (Reuters) (Gray Sheet-$)
• Updated SOFTWARE Act: Still Too Ambiguous For Industry? (Gray Sheet-$)
• FDA ban nearly wiped out deaths, poisonings from ephedra (Reuters) (NEJM)

In Focus: International

• Priority review drugs approved by the FDA and EMA: time for harmonization? (PubMed)
• Parliament votes for tougher regulation of antibiotics (EurActiv)
• Greece owes drugmakers $1.2 billion - and counting (Reuters)
• Finnish Medicines Agency: No evidence of adverse events from biosimilar switches (BioPharma Reporter)
• NICE's new Office for Market Access to help companies secure reimbursement (SCRIP-$) (Pharmafile)
• IQWiG backs Harvoni for certain HCV patients, rebuffs Otezla (BioCentury)
• China jacks up registration fees for medical devices, drugs (MassDevice)
• China FDA Releases Guideline for Medical Device Registration Studies (JD Supra)

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US: Pharmaceuticals and Biotechnology

• SCOTUS Declines Challenge to Alameda County Rx Drug Disposal Law (CA Healthline) (NPR) (Pink Sheet-$)
• Actavis barred from pulling older Alzheimer's drug (Reuters) (WSJ-$)
• FDA gives more time for electronic safety reporting (SCRIP-$) (Pink Sheet-$) (FDA)
• FDA AdComm to Discuss Misuse, Abuse of Oxycontin (FDA)
• Cephalon To Pay $1.2B To End FTC Pay-For-Delay Suit (Law 360-$) (Reuters)
• FDA Wants to Know Whether Spouses Influence how Drug Ads are Perceived (Pharmalot) (FDA)
• Biosimilar Naming Dilemma: If FDA Requires Suffixes, Do Reference Products Need Them, Too? (Pink Sheet-$)
• What Does Pharmacogenomics Have To Do With Product Liability? – Potentially Everything (D&D Law)
• Senator Vitter Proposes to Tweak Statute to Explicitly Permit Office Use Compounding ... As Permitted Under State Law, and to Eliminate “Addressing Inordinate Amounts” in FDA’s MOU with States (FDA Law Blog)
• New bill seeks to spur FDA to form clearer social media rules (MM&M)
• Lawmakers seek to curb skyrocketing generic drug prices (PharmPro)
• Startup AdverseEvents makes side effects a factor in the cost of a drug (BizJournal)
• FDA approves Boehringer Ingelheim’s Stiolto Respimat for COPD (Press) (MedPage Today)
• FDA approves Actavis, Valeant drugs for irritable bowel syndrome (Reuters) (FDA)
• Drug Reimportation Bill Becomes a Campaign Issue (The Hill)
• Bioequivalence Recommendations for Risperidone; Draft Guidance for Industry (FDA)
• CDER Teams up With Sloan Kettering to Develop New Clinical Trial Design Focusing on Black Americans (FDA)
• California Biologics Substitution bill Introduced (Bill)
• U.S. Food and Drug Administration Approves Humalog® 200 units/mL KwikPen (Press)
• FDA Beats Otsuka Suit Over Abilify Generics (Law 360-$)
• Bolder Cures Act Could Ease Limits On Drug Cost Claims (Law 360-$)
• High Foreign Inspection Failure Rate Indicates Need for Better Pharma Risk Modeling and Supplier Oversight Abroad, FDA Compliance Official Stresses (IPQ-$)
• Advisory Committee Track Records (EyeOnFDA)
• FDA Publishes Summary Report of Pediatric Studies of Meropenem (FDA)
• Cipla pulls levalbuterol on FDA warning; Wockhardt removes other drugs on concerns (Fierce)
• Vendor Managed Inventory Under the DSCSA (RxTrace)

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

• Suicide stunner prompts Amgen to dump brodalumab, denting AstraZeneca's rep (Fierce) (Reuters)
• GlobeImmune Hep B drug fails mid-stage study, shares plunge (Reuters)
• AbbVie Presents Phase 3 Data in Japan from Hepatitis C Treatment Study (Press)
• Sanofi, Regeneron Annouce Positive Phase 3 Data for Arthritis Drug (Press)
• New drugs from Bristol, Merck at forefront of cancer meeting (Reuters)
• AMAG Pharmaceuticals Receives Complete Response Letter From FDA for the Single-Dose Vial of Makena (Hydroxyprogesterone Caproate Injection) (Press)
• ZS Pharma Submits New Drug Application to U.S. Food and Drug Administration for ZS-9 for the Treatment of Hyperkalemia (Press)
• FDA Accepts BPL’s Amended BLA Submission for Coagadex (Coagulation Factor X, Human) (Press)
• Biotie designs SPA with FDA (SCRIP-$)

US: Pharmaceuticals and Biotechnology: General

• Express Scripts mulls indication-based pricing in cancer (BioCentury) (WSJ-$)
• Multiple Sclerosis Patients Stressed Out By Soaring Drug Costs (NPR)
• CIPA Study: Many Americans continue to buy meds from Canada to curb costs (DSN)
• Covered California Votes To Cap What Patients Pay For Pricey Drugs (NPR)
• Consumers Sue Anthem for Denying Coverage for a Gilead Hepatitis C Drug (Pharmalot)
• Wal-Mart urges meat suppliers to curb antibiotic use (Reuters)
• FTC Report on Pet Medications Industry Finds Veterinarians Face Increasing Competition from Non-Veterinary Retail Outlets (FTC)

US: Medical Devices

• FBI investigating medical device that spread cancer in women (CBS) (WSJ-$) (NYTimes)
• Researchers oppose unvalidated gene panel tests for cancer links (Reuters) (Gray Sheet-$)
• Updated SOFTWARE Act: Still Too Ambiguous For Industry? (Gray Sheet-$)
• 4 Tips For Speeding Device Reviews, Even Without An 'Expedited' Pathway (Gray Sheet-$)
• To Panel or Not To Panel? FDA May Address Criteria In Upcoming Guidance (Gray Sheet-$)
• FDA approves minimally invasive spinal spacer from startup VertiFlex (Fierce)
• FDA Classifies Multiplex Nucleic Acid Assays as Class II (FDA)
• FDA Classifies Male Climax Control Device as Class II (FDA)
• Should placebos be used in randomized controlled trials of surgical interventions? (SBM)
• Is Your Validation Master Plan in Shape? (MDDI)
• FDA warns Signal Medical on unapproved hip implants (Mass Device)
• FDA: CareFusion's Avea ventilator recall is Class I (MassDevice) (FDA)
• Roche receives FDA clearance for the cobas Cdiff Test to detect Clostridium difficile (Press)
• SurgiQuest's AirSeal System Receives FDA 510(k) Clearance for Transanal Endoscopic Surgery (Press)
• InvisionHeart Receives FDA 510(k) Clearance of its InvisionECG Technology (Press)
• RegenScientific announces FDA-clearance of its Renu® Gel injectable implant (Press)

US: Dietary Supplements

• FDA ban nearly wiped out deaths, poisonings from ephedra (Reuters) (NEJM)
• FDA's decision on CBD likely to be overturned after more info comes in, exec says (NI-USA)

US: Assorted And Government

• White House: ethics of human genome editing needs further review (Reuters) (White House)
• More people with Alzheimer’s are becoming activists — which brings its own challenges (WaPo)

Upcoming Meetings and Events

• RAPS' FDA Advisory Committee Meeting Tracker

Ebola Outbreak

• Approaches to demonstration of Ebola virus vaccine efficacy. (Lancet)

Europe

• Priority review drugs approved by the FDA and EMA: time for harmonization? (PubMed)
• Parliament votes for tougher regulation of antibiotics (EurActiv)
• Greece owes drugmakers $1.2 billion - and counting (Reuters)
• Finnish Medicines Agency: No evidence of adverse events from biosimilar switches (BioPharma Reporter)
• NICE's new Office for Market Access to help companies secure reimbursement (SCRIP-$) (Pharmafile)
• IQWiG backs Harvoni for certain HCV patients, rebuffs Otezla (BioCentury)
• German anti-bribery law threatens current legitimate medtech practices (SCRIP RA-$)
• A Look at MHRA's Early Access to Medicines Scheme (MHRA)
• Otsuka's tolvaptan approved for sale in Europe (SCRIP-$)
• Amicus' rare disease drug lines up for a quick EU approval (Fierce) (Press)
• AZ escapes censure over cancer tweet (PMLive)
• Disappointment for pharma with new Cancer Drugs Fund list (PMLive)
• European Medicines Agency Validates Gilead’s Marketing Application for Fixed-Dose Combination of Emtricitabine and Tenofovir Alafenamide for HIV Treatment (Press)
• EOS imaging Announces CE Mark for kneeEOS, the first 3D Stereo-Radiographic Planning Software for Total Knee Arthroplasty (Press)

India

• Low-Cost Sovaldi Generics in India Make it Cheaper to Fly to India to Receive Treatment (HepMag)
• Indian drug controller to take up massive quality survey (Business Standard)
• State FDA to expedite compensation process in defective medical device recall case (PharmaBiz)

Japan

• Eisai seeks new ALS drug approval (Pharmafile)

China

• China jacks up registration fees for medical devices, drugs (MassDevice)
• China FDA Releases Guideline for Medical Device Registration Studies (JD Supra)
• Sterile mosquitoes released in China to fight dengue fever (Guardian)

Australia

• Australia moves ahead with biosimilar substitution (SCRIP RA-$)
• Company knew risk of thalidomide six months before it was pulled, says book (Guardian)

Other International

• WHA confirms delay in fake drug mechanism review (Securing Industry)
• Implementing the ANSI NSF-IPEC 363 Standard on Excipient GMPs Will Help Ensure Compliance with FDASIA, FMD and EU’s New Excipient Risk Assessment Guideline (IPQ-$)
• Study in Nigeria finds 1 in 10 malaria drugs are poor quality (MNT)
• Countries to explore pooled procurement of vaccines to reduce costs (PharmJournal)

Clinical Trials

• The University of Minnesota’s Medical Research Mess (NYTimes)

General Regulatory And Interesting Articles

• Newer Birth Control Pills Raise Blood Clot Risks, Too (NBC) (Reuters)
• Novartis digs into health tech with bet on 'robotic pill' (Reuters)
• Bayer CEO sees multinational state aid for antibiotics (Reuters)
• Where Is Biopharma in the PAT Picture? (PharmaManufacturing)
• New Obesity Drug Delicious (The Onion-SATIRE)

Regulatory Reconnaissance #564 – 28 May 2015

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.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @AlecGaffney or send him an email at [email protected].

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.