Regulatory Recon: Study Finds FDA AdComm Members With Conflicts of Interest Vote Differently (9 September 2014)

Posted 09 September 2014 | By Alexander Gaffney, RAC 

Regulatory Recon: Study Finds FDA AdComm Members With Conflicts of Interest Vote Differently (9 September 2014)

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

This fall, regulatory professionals from across the globe will come together to learn, connect and share at the Regulatory Affairs Professionals Society’s 2014 RAPS: The Regulatory Convergence, 27 September-1 October, Austin, TX.  Register here.

In Focus: US

In Focus: International

US: Pharmaceuticals and Biotechnology

  • AdComm Members With Acknowledged Conflicts of Interest More Likely to Vote in Favor of Drugs (NYTimes) (Paper)
  • Connecticut AG to FDA: Let Ranbaxy Sell a Generic Nexium, Already (Pharmalot) (FDA Law Blog) (CT AG) (Fierce)
  • FTC Targets AbbVie, Teva In 1st New Pay-For-Delay Suit  (Law 360-$) (WSJ-$) (Pharmafile) (Pink Sheet-$) (Fierce) (Pharmalot)
  • FDA seeks comments on two issues related to animal drug approvals (Cattle Network) (FDA) (FDA) (FDA) (FDA)
  • Reviewers ask FDA for CV 'polypill' development pathway (BioCentury) (Tarius)
  • Three Days Or Less: CDER Spells Out Disclosure Goals For Drug Approvals (Pink Sheet-$)
  • Less is More: Modernizing Quality Standards for Over-The-Counter Drugs (USP)
  • Democrats call for HHS review of gay blood, organ donations (The Hill)
  • How Novartis built clinical case to replace generics in heart failure (BioCentury)
  • FDA Approves Use of Menactra Vaccine for Booster Immunization Against Potentially Deadly Disease (Press)
  • FDA approves Epaned for treatment of symptomatic and asymptomatic heart failure (Press)
  • NRAA asks FDA to consider allowing import of PD solutions, warns of hardships if shortage continues (Nephrology News)
  • Perrigo recalls 367,000 tubes of nicotine lozenges (Fierce)
  • More Obesity Drugs Seek to Enter Still Struggling Market (Bloomberg) (Press)
  • Pfizer, Purdue Prevail In Suit Over Settlement Records (Law 360-$)
  • Should Antibiotics be Dosed According to a Patient's Weight? (Healio)
  • Shire, Neos Therapeutics Enter Patent Use Settlement (Press)

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

  • Moxifloxacin regimens miss Phase III endpoint (BioCentury)
  • TESARO Announces Submission of Rolapitant New Drug Application (NDA) to U.S. Food and Drug Administration (Press)
  • Lachman Files Suitability Petition Seeking Generics of Capecitabine (Xeloda) (FDA)
  • Emergent BioSolutions Awarded Contract to Develop a Dry Formulation of NuThrax, a Next Generation Anthrax Vaccine (Press)
  • Sanofi Pasteur Announces Publication Of Positive Data For Fluzone High-Dose Vaccine In The New England Journal Of Medicine (Press)
  • Nintedanib slowed disease progression in IPF independent of patients’ lung function impairment at baseline (Press)

US: Pharmaceuticals and Biotechnology: General

  • U.S. to Allow Pharmacies to Take Back Unused Prescription Drugs (WSJ-$) (NPR) (NYTimes) (Reuters) (The Hill) (DEA Rule)
  • Homeland Security botched pandemic preparedness : U.S. report (Reuters) (CBS) (OIG)
  • Republicans Can’t Stop Talking About Over-the-Counter Birth Control (TIME)
  • CDC: No drugs, vaccines to combat Enterorvirus spread (SCRIP-$)

US: Medical Devices

  • Q2 Medical Device Recalls Data Tell A Mixed Story (MDDI) (SteriCycle)
  • GE Healthcare, FBI allege Chinese engineer stole MRI trade secrets (Fierce) (Journal-Sentinel)
  • Morcellation Critic Dares Device Maker on Lawsuit Threat (Medscape)
  • FDA urged to provide oversight of high risk laboratory developed tests (Press)
  • Titan Spine's new warranties cover revision surgery for spinal implants (Mass Device)

US: Dietary Supplements

  • Hi-Tech CEO’s Get-Out-Of-Jail Card: Full Recall Of Weight Loss Supplements (Tan Sheet-$)
  • Applied Food Sciences To Pay $3.5M Over Weight-Loss Claims (Law 360-$) (The Hill)
  • Don’t Take Your Vitamins (538)
  • Concerns raised over soy supplementation: Study (NI-USA)

US: Assorted And Government

  • The DSM and the Attempt to Redefine Mental Disorders (BioCenturyTV)

Upcoming Meetings

Ebola Outbreak

  • GlaxoSmithKline's Ebola vaccine aces an animal study amid R&D fervor (Fierce)
  • Pentagon joins fight against Ebola outbreak (The Hill)




  • Mazor Robotics Receives China CFDA Approval for Its Renaissance Systems (Press)


  • Japan Recommends Edoxaban For Stroke Prevention (PharmAsia-$)


  • Canada: A Haven for Internet Pharmacies and Organized Crime (S4S)
  • Shortage of Bladder Cancer Drug Could be Tragic for Patients, Doctor Says (Candian Press)


  • Submissions and TGA response: OTC nasal decongestant preparations for topical use: proposed advisory statements for medicines (TGA)
  • Submissions and TGA response: OTC cough medicines for oral use: proposed advisory statements for medicines (TGA)
  • Australia's free HPV vaccine program is a big success (Vox)

Clinical Trials

  • Mayo Clinic hopes Watson can find more patients for its 8,000 clinical trials (MedCityNews)
  • Biologics trials: the ‘stretched’ global supply chain (Outsourcing Pharma)

General Regulatory And Interesting Articles

  • When Feces Is the Best Medicine (The Atlantic)
  • Genetic testing brings families together--And sometimes tears them apart (Vox)
  • Coalition Urges Nations to Decriminalize Drugs and Drug Use (NYTimes) (WaPo)
  • Near Death, and Overmedicated (NYTimes) (Bloomberg)

Regulatory Reconnaissance #395 – 9 September 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.

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

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

Categories: Recon, Regulatory News

Regulatory Focus newsletters

All the biggest regulatory news and happenings.


Most Viewed Articles