Regulatory Recon: Female Libido Pill Caused Dissent in FDA Ranks (17 September 2015)

Posted 17 September 2015 | By Zachary Brennan 

Regulatory Recon: Female Libido Pill Caused Dissent in FDA Ranks (17 September 2015)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher , @Zachary Brennan and @RAPSorg on Twitter.

In Focus: US

In Focus: International

  • Cancer Drugs Fund ‘not sustainable in current form’ (Pharmafile) (PharmaTimes) (Pharmaphorum) (PharmaLetter-$)
  • EMA pre-authorisation procedural advice for users of the centralised procedure (EMA)
  • India mulls reclassifying vitamins as drugs if they come with health claims (In-PharmaTechnologist)
  • A new class of drugs is here – but India is dangerously inept at dealing with them (Scroll)

US: Pharmaceuticals and Biotechnology

  • Perrigo rejects Mylan's tender offer (Reuters)
  • OrbiMed sets its sights on a $950M blockbuster biotech fund (FierceBiotech)
  • Alector Raises $32M For Immune-Based Neuro Drug Development (Xconomy)
  • Amgen's Acquisition Of Dezima And CETP Drug Like Pfizer's '03 Buy Of Esperion. Will History Repeat? (Forbes) (FDANews-$)
  • AbbVie Hires JP Morgan Banker As Chief Strategy Officer (WSJ-$)
  • FDA’s Office of New Drug Products Places Order for 50 Additional Licenses to GastroPlus (Press)
  • Sens. Urged To Unveil Painkiller Probe Of Purdue, J&J, Endo (Law360-$)
  • Ex. Pfizer Co. Beats Much Of Defective Poultry Vaccine Suit (Law360-$)
  • Coram Gets Warning Letter over Sterile Drug Deficiencies (FDANews-$)
  • Blowing past the label: Chapter II of Brill's story on J&J (Huffington Post) Chapter III (Huffington Post)

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

  • FDA Grants Fast Track Designation to Can-Fite's CF102 in the Treatment of Liver Cancer (Press)
  • TG Therapeutics Announces Special Protocol Assessment (SPA) Agreement With the FDA (Press)
  • Researchers: 2001 Paxil study seems to play down suicide risks to youths (Washington Post) (MedPage Today) (Reuters)
  • The Blood Pressure Study Had Positive Findings -- So Why Are Some Doctors Annoyed? (Forbes)
  • A player in J&J's hep C cocktail helps hustle a quick cure (FierceBiotech)
  • Aerie skyrockets on a mixed success in second PhIII glaucoma study (FierceBiotech) (Xconomy) (WSJ-$)
  • Asthma: U.S. FDA approves new indication for Spiriva Respimat (Press) (SCRIP-$)
  • Dimension Therapeutics Announces FDA Fast Track Designation for Lead Candidate DTX101 in Patients with Hemophilia B (Press)

US: Medical Devices

  • J&J Unit Wants $1.2M Pelvic Mesh Judgment Wiped Out (Law360-$)
  • 2 Undercover Ways Medtech is Using 3-D Printing (MDDI)
  • APPROVALS ANALYSIS: Big Jump In CE Marks, But Slow August For PMAs (Clinica-$)
  • Device Firms Should Not Ignore Pharma Off-Label Suits, Experts Say (Gray Sheet-$)
  • Precision Spine Announces FDA Approval of the Reform Modular and HA Coated Pedicle Screw Systems (Press)
  • Medtronic Launches Arc Support Catheter Series in U.S. for Treatment of Acute Ischemic Stroke (Press)
  • Married couple has pled guilty in federal court to selling fake medical devices (MedCity News)
  • Hoya’s Pentax Medical buys stake in Creo (Mass Device)
  • Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device User Fee Small Business Qualification and Certification (Federal Register)
  • Seven FDA Experts to Deliver Quality Metrics Update at Medical Device Summit 2015 (Press)
  • Class 3 Device Recall Pointe Scientific Creatinine Reagent (FDA)
  • Class 2 Device Recall Aliquot Delivery Kit (Syringe and Plunger) (FDA)
  • Class 2 Device Recall CIDEX OPA Solution (FDA)
  • Class 2 Device Recall Pressure Monitoring Kit (FDA)

US: Assorted and Government

  • Consumer Comments-Public Posting and Availability of Comments Submitted to FDA Dockets (Federal Register)
  • Department of Health and Human Services, AstraZeneca to develop antibiotics (Reuters)
  • Senate Should Reject President’s Nominee to Be the Next FDA Commissioner (Public Citizen)
  • BIO Statement on Nomination of Dr. Robert Califf as FDA Commissioner (Press)
  • A Califf Regime: The Disruptor FDA, Pharma And Medtech Needs (SCRIP-$)
  • Bill May Weaken FDA Oversight of Drugs/Devices (MedPage Today)
  • Congress should save reasonable patent reform (The Hill)
  • FDA Tells Senate Subcommittee Full Funding is ‘Absolutely Critical’ for FSMA Success (Food Safety News)
  • Key Considerations for Designing and Implementing Regulatory Fees (GAO)
  • The Cures Act wants to put more tools in the hands of those who fight drug-resistant bacteria. Can this war be won? (Proto Mag)

Upcoming Meetings and Events              


  • Council Of Europe Turns The Screw On Drug Pricing, Conflicts Of Interest - And More (SCRIP-$)
  • Avastin In AMD: French Court Verdict Imminent (SCRIP-$)
  • NICE says Celgene's Abraxane is 'too expensive for pancreatic cancer' (Pharmafile) (PharmaLetter-$)
  • The dates of 2016 SAWP meetings and deadlines for submission of scientific advice, protocol assistance, qualification of biomarkers and parallel EMA/HTA requests (EMA)
  • UK MHRA Pilot To Explore Benefits Of Standalone Inspections For Pharmacovigilance Service Providers (SCRIP-$)
  • Commission and WHO Europe scale up cooperation (European Commission)
  • NICE Evaluation and Tariff Code Announcements to Increase UroLift® System Availability in UK NHS Patients with Enlarged Prostate (Press)


  • Devices Sponsor Information Day (TGA)


  • Indian drug makers to look out for more overseas buys (Business Today)


  • More layoffs ahead as Analogic shifts some production to China (Mass Device)


  • Zenyaku Ends Japan Alliance With Anthera (SCRIP-$)

Ebola Outbreak

  • Fighting Ebola With a Palm-Sized DNA Sequencer (Atlantic)
  • Bavarian Nordic wins up to $33m to develop J&J Ebola vaccine (BioPharma-Reporter)
  • Experimental Ebola vaccine regimen takes new steps under HHS program (HHS)

Other International

  • Illegal online pharmacies a source of fake drugs says Estonian regulators (In-PharmaTechnologist)
  • APIC revises the How to Do Document on ICH Q7 (ECA)

General Health and Other Interesting Articles

  • The GOP’s dangerous ‘debate’ on vaccines and autism (Washington Post)
  • Ben Carson Doesn't Get It: All Our Vaccines Prevent Death (Forbes)
  • Trump and Carson think it's okay to delay vaccines. Doctors say they're wrong. (Vox)
  • Health Care Gains, but Income Remains Stagnant, the White House Reports (NY Times)
  • Millions of children's lives saved as malaria deaths plunge: U.N. (Reuters)

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 @Michael_Mezher or send him an email at

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

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