Regulatory Recon: FDA Calls for New Study, Warning for Essure McClellan Says FDA Should Not Be Reorganized in a Hurry (29 February 2016)

Posted 29 February 2016 | By Zachary Brennan 

Regulatory Recon: FDA Calls for New Study, Warning for Essure McClellan Says FDA Should Not Be Reorganized in a Hurry (29 February 2016)

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

In Focus: US

  • FDA takes additional action to better understand safety of Essure, inform patients of potential risks (FDA) (Reuters) (Mass Device) (Bloomberg) (Focus)
  • AARP: Price hikes doubled average drug price over 7 years (AP)
  • Docs promoting on social media don’t disclose pharma ties (STAT)
  • Don't Rush To Reorganize FDA, McClellan Says (Pink Sheet-$)
  • The First Amendment Does Not Undermine the Preemption of Medical-Device Failure-to-Warn Suits (Washington Legal Foundation)
  • Top Lobbyist for Drug Makers Threads a Thicket of Outrage (NY Times)
  • Another Court Weighs In on Whether Off-Label Promotion is Per Se Illegal; Jury Finds Both Defendants Not Guilty on All Counts (FDA Law Blog)
  • Three new first generics approved by FDA in February (FDA)
  • Sen. Tom Cotton letter to Califf on ANDA backlog (Letter)
  • FDA Clears Zika Diagnostic for Emergency Use (FDA) (Focus)

In Focus: International

  • Bad Science Means Good Business for Abbott in India (MedPage Today)
  • Indian drug regulators meet MHRA officials in a move to ease exports to UK (PharmaBiz)
  • China says to speed up approvals for some drugs (Reuters)
  • Advice on the impact on public health of the use of antibiotics in animals (colistin) following the recent discovery of the first mobile colistin resistance gene (EMA)
  • Bial cannot rule out link between BIA 10-2474 and lung lesions in study dogs (InPharma-Technologist)
  • Sandoz receives positive CHMP opinion for biosimilar Binocrit (PR)

US: Pharmaceuticals & Biotechnology

  • Boehringer, AbbVie Said to Be in Cancer-Partnership Talks (Bloomberg News)
  • Sentinel For Biosimilars? Biologics Post-Market Monitoring Is Focus Of New Consortium (Pink Sheet-$)
  • Biosimilar Uptake Could Be Driven By Outcomes-Based Contracts (Pink Sheet-$)
  • PDUFA Negotiations End, Approval Process Ongoing (Pink Sheet-$)
  • FDA Orphan Designations At Record Levels; Resources Need To Keep Up (Pink Sheet-$)
  • FTC's Generic Market Analysis Forcing Divestures Even In Diverse Categories (Pink Sheet-$)
  • BioMarin Looking To Break Even Despite Kyndrisa Uncertainty (Pink Sheet-$)
  • Building A Foundation: Express Scripts’ Miller On Recent Outcomes-Based Contracts (Pink Sheet-$)
  • Diabetes Manufacturers Brace Under Shifting Market Dynamics (Pink Sheet-$)
  • Duke Center Floats Tiered Labels, 3rd Party Review As Possible Off-Label Solutions (InsideHealthPolicy-$)
  • DTC Drug Advertising: FDA to Launch First Public Survey Since 2002 (Focus)
  • His Job Is to Sell a $1,000 Pill for $10 Without Losing Money (Bloomberg News)
  • Valeant CEO to return following illness (PR) (SCRIP-$)
  • Sanofi scouts for rare disease buyouts as Shire bears down on the field (FierceBiotech)(FT-$)

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

  • AstraZeneca cancer drug fails in mesothelioma trial (Reuters)
  • Benzodiazepine prescriptions, overdose deaths on the rise in U.S. (Reuters)
  • Rivals chase Bristol-Myers in cancer immunotherapy drug race (Reuters)
  • Regeneron Eye Drug's Advantage Over Roche's Narrowed in Trial (Bloomberg)
  • Roche suffers setback as severe asthma drug fails in one study (Reuters) (PR)
  • Journals flag 6 papers, request investigation of New Jersey university biologists (Retraction Watch)
  • Study Shows Addyi is Not "Female Viagra" by Any Stretch of the Imagination (Pharma Marketing Blog)

US: Medical Devices

  • In brief: Latest version of ISO 13485 published (Mass Device)
  • Walgreens looks to cut ties with Theranos (FT-$)
  • Abbott Issues Voluntary Safety Notice on MitraClip® Delivery System Deployment Process (FDA)
  • New recommendations for responding to medical device cybersecurity risks (PwC)

US: Assorted & Government

  • White House Reviewing CMS' Planned Part B Drug Reimbursement Demo (InsideHealthPolicy-$)
  • FDA Discusses How to Regulate NGS Tests for Cancer (Focus)
  • Government versus FDA: The RESULT Act (PharmaLetter-$)
  • US lawmakers expand probe of climate study (Nature News)
  • Salt shaker: FDA trial hold on pain drug sodium hitch to help Cara rival Trevena? (BioWorld-$)
  • Feds order Ocala man to stop peddling drug as herpes cure (AP)
  • Sen. Markey: Opioid addiction and overdose crisis will continue until FDA reforms (Patch)

Upcoming Meetings & Events


  • Glaxo launches search for new chief (Telegraph) (BioSpace)
  • European Committee for Medicinal Products for Human Use recommends approval of Giotrif® (afatinib) for advanced squamous cell cancer of the lung (PR)
  • CHMP recommends Lilly psoriasis drug for approval (Pharmafile)
  • Positive EMA/CHMP opinion for AbbVie’s Viekirax + Exviera (PharmaLetter-$)
  • More Enforcement for Data Integrity Problems (Unger Consulting)
  • Germany Slaps PTC Therapeutics With Big Drug Price Cut (TheStreet)
  • EU Pilot On Incident Reporting: Lessons Learned So Far And Next Steps (Clinica-$)
  • Swiss Basilea says profits still 2-3 years away (Reuters)


  • AstraZeneca sells two heart drugs to China Medical for $500 mln (Reuters) (FT-$)
  • China seeking comment on drug traceability changes (Securing Industry)
  • Japan amends Pharmaceutical Affairs Act to attract Indian pharma cos to invest heavily in Japan (PharmaBiz)
  • Astellas Receives Approval for a Supplemental New Drug Application for Kiklin® Capsules, a Treatment for Hyperphosphatemia, in Japan (PR)
  • Eisai wins Japan approval for Halaven for soft tissue sarcoma (PR)


  • Hearing on Gilead's patent for hepatitis C drug, sofosbuvir, begins at patent office (PharmaBiz)
  • India making strong progress in biosimilars, with local market estimated at over $900 million (PharmaLetter-$)
  • Budget 2016: Medical device industry hopes for ‘Make in India’ sops (Economic Times)
  • CDSCO notice on e-filing system SUGAM (CDSCO)
  • Govt to weed out many irrational FDCs from market soon (PharmaBiz)


  • The Poisons Standard (the SUSMP) (TGA)

Zika Virus

  • Argentina woman contracts Zika without leaving the country (Reuters)
  • France says detects first sexually transmitted Zika case (Reuters)
  • Climate information may be key weapon in fight against Zika spread (Reuters)
  • Scottish nurse, who suffered from Ebola, discharged from hospital (Reuters)

Other International

General Health & Other Interesting Articles

  • We polled 1,060 Americans about abortion. This is what they got wrong. (Vox)
  • Your lifetime risk of HIV by race, state and sexual preference — in four simple charts (Washington Post)
  • Surgical Resident Duty-Hour Rules — Weighing the New Evidence (NEJM)
  • The Agonizing Limbo Of Abandoned Nursing Home Residents (Kaiser Health News)

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.

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