Regulatory Focus™ > News Articles > Regulatory Recon: Amarin Sues FDA, Citing Free Speech Harms of Off-Label Limits (8 May 2015)

Regulatory Recon: Amarin Sues FDA, Citing Free Speech Harms of Off-Label Limits (8 May 2015)

Posted 08 May 2015 | By Alexander Gaffney, RAC 

Regulatory Recon: Amarin Sues FDA, Citing Free Speech Harms of Off-Label Limits (8 May 2015)

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

In Focus: US

  • Irish drugmaker sues FDA under First Amendment (Reuters) (Pharmalot) (Forbes) (Forbes) (NYTimes) (Pink Sheet-$) (SCRIP-$)
  • The FDA Is On A Quest To Rid DTC Drug Ads Of Confounding Fine Print (Forbes)
  • FDA staff question efficacy of Vertex experimental CF drug in combination (Reuters)
  • FDA Guidance Document on Off-Label Communications on its Way (BioCentury)
  • HHS Unveils New Organ Donation Policy for Patients With HIV (HHS)
  • Human Factors Questions Drive Rise In FDA Inter-Center Consults (Gray Sheet-$)
  • Vitamin Shoppe Won’t Sell Supplements Containing BMPEA (NPI)

In Focus: International

  • WHO adds hepatitis C drugs to essential list, urges lower prices (Reuters) (WHO) (KEI)
  • ICH Prepares for Major Reform (PharmTech)
  • EMA clears Novartis' lung cancer drug Zykadia (PMLive) (Reuters)
  • EC begins selecting candidates for EMA executive director job (SCRIP-$)
  • EMA's PRAC Conducting Review of Tysabri (EMA)
  • China kicks press into high gear to knock down talk on higher drug prices (Fierce)
  • China's top court invalidates Lipitor patent (BioCentury)
  • Pfizer to compensate Parkinson’s sufferers over gambling, sex addictions (Guardian)

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US: Pharmaceuticals and Biotechnology

  • Irish drugmaker sues FDA under First Amendment (Reuters) (Pharmalot) (Forbes) (Forbes) (NYTimes) (Pink Sheet-$) (SCRIP-$)
  • The FDA Is On A Quest To Rid DTC Drug Ads Of Confounding Fine Print (Forbes)
  • FDA staff question efficacy of Vertex experimental CF drug in combination (Reuters)
  • FDA Guidance Document on Off-Label Communications on its Way (BioCentury)
  • HHS Unveils New Organ Donation Policy for Patients With HIV (HHS)
  • How Not to Submit Interactive Materials to FDA (RegulatoryRx)
  • FDA Revises Field Inspections to Reflect Global Market and Quality Initiatives (PharmTech)
  • FDA AdComm to Discuss GSK's Mepolizumab (FDA)
  • Dollars, Not New Authorities Needed To Advance Precision Medicine, FDA Chiefs Say (GraySheet-$)
  • Calif. High Court OKs Pay-For-Delay Challenges (Law 360-$) (Press)
  • BMJ Editorial: Rushed approvals result in a poor deal for both patients and cancer research (BMJ)
  • Generic Launch at Risk: No Patent Damages for Pediatric Exclusivity Period (PCM)
  • FDA's CBER Seeking Nominations to its Vaccines and Related Biological Products Advisory Committee (FDA)
  • Reagan-Udall Foundation Asking for Nominations to its Committees (FR) (FR)

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

  • FDA Grants Fast Track Designation to Sucampo's Cobiprostone for Oral Mucositis (Press)

US: Pharmaceuticals and Biotechnology: General

  • Abuse of Pain Pills Fuels Virus’s Spread, Confounding Regulators (Bloomberg)
  • Gilead shareholders vote against price disclosure proposal (BioCentury)
  • Pharmaceutical firm wants lethal injection drugs returned (AP)
  • Tyson to Adopt New Standard on Antibiotics Use in Poultry (WSJ-$)
  • Sandoz Asks For Distinct Reimbursement Code For First U.S. Biosimilar (IHP-$)

US: Medical Devices

  • Human Factors Questions Drive Rise In FDA Inter-Center Consults (Gray Sheet-$)
  • Pew Submits Comments to National Medical Device Postmarket Surveillance Planning Board (Pew)
  • Class I Recall for Macquet Tiger Paw Device (FDA) (FDA) (Law 360-$)

US: Dietary Supplements

  • Vitamin Shoppe Won’t Sell BMPEA Supplements Per Agreements with Vermont, Oregon Attorneys General (NPI)

US: Assorted And Government

  • FDA's Weekly Enforcement Report (FDA)

Upcoming Meetings and Events

Ebola Outbreak

  • NIH Ebola vaccines trial meets 1,500 enrollment goal (SCRIP-$)

Europe

  • EMA clears Novartis' lung cancer drug Zykadia (PMLive) (Reuters)
  • EC begins selecting candidates for EMA executive director job (SCRIP-$)
  • EMA's PRAC Conducting Review of Tysabri (EMA)
  • EU patent office revokes Celgene Revlimid patent; appeal planned (Reuters)
  • Surefire Medical’s New Precision Infusion System for Embolization Procedures Receives CE Mark Approval (Press)

China

  • China kicks press into high gear to knock down talk on higher drug prices (Fierce)
  • China's top court invalidates Lipitor patent (BioCentury)

Australia

  • Pfizer to compensate Parkinson’s sufferers over gambling, sex addictions (Guardian)
  • TGA Opens Consultation on IMDRF Software Proposal (TGA)

Other International

  • WHO adds hepatitis C drugs to essential list, urges lower prices (Reuters) (WHO) (KEI)
  • ICH Prepares for Major Reform (PharmTech)

General Regulatory And Interesting Articles

  • Fake, low-grade drugs hinder drive against disease, weaken trust: researchers (Reuters)
  • Best Document Management Practices for Medical Device Startups: Don’t Cheap Out (MedScrum)
  • Study shows measles vaccine thwarts other infectious diseases (Reuters) (NBC) (NPR)
  • 3-D Printing Of Medical Devices Has Many Dimensions (Law 360-$)

Regulatory Reconnaissance #553 – 8 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 news@raps.org.

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


Categories: Recon, Regulatory News

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