Regulatory Recon: FDA Teams up With PatientsLikeMe to Boost Drug Safety (15 June 2015)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US

• FDA to Work With Online Patient Forum to Mine Drug Safety Data (Bloomberg) (Outsourcing Pharma) (MobiHealthNews) (MedCityNews) (Fierce) (Press)
• How Often Are Drugs Withdrawn For Safety or Effectiveness Reasons? (FDA Law Blog)
• FDA's Inaugural Biosimilar Review Bumpier Than First Appeared (Pink Sheet-$) (Pink Sheet-$)
• Aid to Women, or Bottom Line? Advocates Split on Libido Pill (NYTimes) (Forbes)
• FDA Approves Second Brain Implant for Parkinson's Symptoms (WSJ-$) (Reuters) (FDA)
• Fish and Wildlife Service to Protect Chimps From Research (WaPo)

In Focus: International

• Medical Device Regulation Reforms Move Forward (MedicalDevicesLegal)
• Will new EU rules see industry lose their voice in regulatory dialogue and decision-making? (Clinica-$)
• Spain: 6,000 patients under observation over faulty orthopedics scandal (El Pais)
• New, bigger EU market surveillance project in the wings (Clinica-$)
• EU moves towards increased transparency of decision-makers' work (Clinica-$) (EC)
• EU drugs partnership IMI gets new chief (Politico)
• Public Consultation On The Preliminary Opinion On Surgical Meshes (SCENIHR) (EC)
• New EGA group to promote access to ''value-added'' drugs (SCRIP-$) (EGA)

US: Pharmaceuticals and Biotechnology

• FDA to Work With Online Patient Forum to Mine Drug Safety Data (Bloomberg) (Outsourcing Pharma) (MobiHealthNews) (MedCityNews) (Fierce) (Press)
• How Often Are Drugs Withdrawn For Safety or Effectiveness Reasons? (FDA Law Blog)
• Active Ingredients vs. Active Moieties – Perplexity of Understanding the Relationship or Distinction (Camargo) (Cooley)
• Aid to Women, or Bottom Line? Advocates Split on Libido Pill (NYTimes) (Forbes)
• FDA's Inaugural Biosimilar Review Bumpier Than First Appeared (Pink Sheet-$) (Pink Sheet-$)
• Zarxio Syringe's Limitations May Delay Decision On Neupogen Interchangeability (Pink Sheet-$)
• How To Label A Biosimilar? Copy The Reference Product, FDA Told Sandoz (Pink Sheet-$)
• Biosimilar Pathway Quickly Becoming Crowded In U.S. (Pink Sheet-$)
• Sorry, Wrong Email: FDA's 'Oops' Moment In The Zarxio Review (Pink Sheet-$)
• FDA DSCSA Deliverables Are Bunching Up In Second Half of 2015 (RxTrace)
• Praluent, Repatha Spur Rethinking On LDL-Cholesterol As A Surrogate Endpoint (Pink Sheet-$) (MedPage Today)
• A Tainted High: Lax State Rules, Inconsistent Lab Practices And Inaccurate Test Results Put Pesticide-Laced Pot On Dispensary Shelves (Oregon Live)
• U.S. Food and Drug Administration Approval Summary: Enzalutamide for the Treatment of Patients With Chemotherapy-Naïve Metastatic Castration-Resistant Prostate Cancer (PubMed)
• US Capitol Capsule: Caution biopharma: wacky Washington wild ride ahead (SCRIP-$)

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

• Teva Announces FDA Acceptance of the Biologics License Application for Reslizumab (Press)
• Aveo endures yet another FDA setback (Fierce)
• On-Label Nasal Naloxone in the Works (MedPage Today)
• Bluebird Bio's sickle cell gene therapy working for French boy (Reuters) (WSJ-$) (Press)
• AstraZeneca Announces Phase III Results for Lesinurad in Combination with Febuxostat in Tophaceous Gout Patients (Press)

US: Pharmaceuticals and Biotechnology: General

• ​Skyrocketing drug prices leave cures out of reach for some patients (USA Today)
• Prescription Drug Price Battles Show No Sign Of Letting Up (KHN)
• Prescription for change: Investigating overpriced drugs (CBS)
• Paper Suggests Making Drug Exclusivity Contingent On Reasonable Prices (IHP-$)

US: Medical Devices

• FDA Approves Second Brain Implant for Parkinson's Symptoms (WSJ-$) (Reuters) (FDA)
• Oculus Rift virtual reality headset finds medical uses (MassDevice)
• Sanovas wins FDA 510(k) clearance for PulmoVia (MassDevice) (Press)
• Ventana receives FDA approval for the first fully automated IHC companion diagnostic to identify lung cancer patients eligible for XALKORI (Press)

US: Dietary Supplements

• What Side Are You On? Homeopathic Drugs Comments Top 3500 (Lachman)

US: Assorted And Government

• Fish and Wildlife Service to Protect Chimps From Research (WaPo)
• GOP-controlled panel backs medical marijuana laws (AP)

Upcoming Meetings and Events

• RAPS' FDA Advisory Committee Meeting Tracker

Ebola Outbreak

• Obama administration pushes for faster Ebola test (The Hill) (HHS) (HHS) (MedCityNews)

Europe

• Medical Device Regulation Reforms Move Forward (MedicalDevicesLegal)
• Will new EU rules see industry lose their voice in regulatory dialogue and decision-making? (Clinica-$)
• Spain: 6,000 patients under observation over faulty orthopedics scandal (El Pais)
• New, bigger EU market surveillance project in the wings (Clinica-$)
• EU moves towards increased transparency of decision-makers' work (Clinica-$) (EC)
• EU drugs partnership IMI gets new chief (Politico)
• Public Consultation On The Preliminary Opinion On Surgical Meshes (SCENIHR) (EC)
• New EGA group to promote access to ''value-added'' drugs (SCRIP-$) (EGA)
• EU Releases New Data Protection Approach (EU) (EFPIA)
• Astellas' Xtandi cancer drug rejected by NICE (PMLive) (Pink Sheet-$)
• Medicines watchdog sentences man for selling abortion tablets and counterfeit Viagra (UK)

India

• India's patent law may face legal hurdle at WTO (LiveMint)
• Kerala lacks efficient quality control system for drug testing: Dr Satheesh Kumar (PharmaBiz)

Canada

• Guidance on Medical Device Compliance and Enforcement (Health Canada)
• Sanofi Recalls Vaccine to due Delivery Defect (Healthy Canadians)

General Regulatory And Interesting Articles

• Imagine if the media covered alcohol like other drugs (Vox)

Regulatory Reconnaissance #575 – 15 June 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.