Regulatory Focus™ > News Articles > Regulatory Recon: Does the Government Have an Inconsistent Story on Ebola? (19 August 2014)

Regulatory Recon: Does the Government Have an Inconsistent Story on Ebola? (19 August 2014)

Posted 19 August 2014 | By Alexander Gaffney, RAC 

Regulatory Recon: Does the Government Have an Inconsistent Story on Ebola? (19 August 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 by 29 August 2014 to receive the lowest rate.

In Focus: US

  • The Federal Government’s Inconsistent Ebola Story (Morning Consult)
  • Pfizer is Liable for Harm Caused by a Generic Version of its Drug: Court (Pharmalot) (Focus) (Fierce) (SCRIP-$)
  • FDA approves Biogen MS drug Plegridy (Pharma Times) (Press) (Reuters) (MedPage Today) (SCRIP-$) (Reuters)
  • FDA Approves Use of AFLURIA Influenza Vaccine with PharmaJet’s Needle-Free Injector (Press) (BioPharma Reporter)
  • GOP Considering Proposal to Make Birth Control Products OTC (The Hill)
  • FDA Abandons “Pre-Decisional” IDE Proposal (Gray Sheet-$)
  • Masimo reveals FDA warning letter over Pronto 7 monitor (Mass Device)
  • Senators Want More Companies to Pull Surgical Device From Market (WSJ-$)
  • Gap in Food-Safety Leadership Grows as FDA Hunts for Permanent Supplement Chief (NPI)

In Focus: International

  • Eisai ‘outraged’ by IQWIG’s failure to back epilepsy drug (PMLive) (PharmaPhorum) (BioCentury)
  • NICE to re-evaluate Firmagon for advanced hormone-dependent prostate cancer (PharmaPhorum) (BioCentury) (SCRIP-$)
  • Cannabinoid Sativex approved in Wales to treat MS symptoms (PharmJournal)
  • Exporters ask DoP to make India a member country of PICS to overcome hurdles in these countries (PharmaBiz)
  • Indian Health Ministry seeking compulsory license for B-MS’ Sprycel (Pharma Letter-$)
  • Chinese trials could face more bureaucracy (BioCentury) (PharmAsia-$)
  • Health Canada toughening prescription-narcotic warning labels to combat abuse (National Post)

US: Pharmaceuticals and Biotechnology

  • Pfizer is Liable for Harm Caused by a Generic Version of its Drug: Court (Pharmalot) (Focus) (Fierce) (SCRIP-$)
  • FDA approves Biogen MS drug Plegridy (Pharma Times) (Press) (Reuters) (MedPage Today) (SCRIP-$) (Reuters)
  • FDA Approves Use of AFLURIA Influenza Vaccine with PharmaJet’s Needle-Free Injector (Press) (BioPharma Reporter)
  • GOP Considering Proposal to Make Birth Control Products OTC (The Hill)
  • Eli Lilly insulin drug receives tentative U.S. approval (Reuters) (Press) (Fierce) (SCRIP-$)
  • Generic Exclusivity Awards Process Might Go Public (Pink Sheet-$)
  • FDA’s Office of Generic Drugs Wants to Partner With Industry to Develop Best Practices (FDA Law Blog)
  • FDA's "Off-Label Risk Reduction" Approach to Reprint Distribution is "Misguided," Says Sidney Wolfe (Pharmaguy) (JAMA)
  • Generics Lobby Not Fully Sold On FDA Biosimilars Guidance (Law 360-$)
  • Physician groups call for separate names for biosimilars, reference biologics (BioPharma Reporter) (Letter) (Pharmalot) (Fierce)
  • Jurassic Products: FDA Resurrects Withdrawn Drugs To Study Liver Injury (Pink Sheet-$)
  • GMP False Claims Case Falters, But Pharma Isn’t In Clear Yet (Pink Sheet-$)
  • Labeling Would Include More Subgroup Findings Under Revised Guidance (Pink Sheet-$)
  • FDA holding workshop on developing drugs for staph (BioCentury)
  • Reprieve for AstraZeneca as US drops drug investigation (Pharmafile) (Press) (Pink Sheet-$) (Reuters)
  • FDA Takes a Different Road on Generic PRECEDEX and Issues Letter Decision Allowing ANDA Labeling Carve-Outs (FDA Law Blog) (Street Insider)
  • Regulatory science and generic prescription drugs (FDA)
  • PhRMA Says Integrilin FCA Suit Stifles Free Speech Rights (Law 360-$)
  • Abbott, AbbVie Win Dismissal of Suit Over Depakote Marketing (Bloomberg)
  • Leaders and laggards in FDA approval stakes (EP Vantage-$)
  • Turkish Man Pleads Guilty to Importing Illegal Cancer Drugs (FDA)
  • FDA Public Workshop: Innovations in Breast Cancer Drug Development – Next Generation Oncology Trials, Breast Cancer Workshop (FDA)
  • Sun Pharma recalls nearly 500,000 bottles of antibiotics (Fierce)
  • Recall of Baxter's Dialysis Solution due to Presence of Particulate Matter (FDA)

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

US: Pharmaceuticals and Biotechnology: General

  • Gilead fends off Roche as hep C heavyweights fight for blockbuster rights (Fierce) (Law 360-$) (Market Watch)
  • Side Effect Warnings Can Increase Pharmaceutical Sales (Forbes)
  • The Health and Economic Effects of Counterfeit Drugs (PMC)
  • FedEx Faces Additional Charges in Prescription-Drug Delivery Case (WSJ-$)
  • Waltham firm designing the drugstores of the future, spurred by federal law (BioFlash)

US: Medical Devices

  • FDA Abandons “Pre-Decisional” IDE Proposal (Gray Sheet-$)
  • Masimo reveals FDA warning letter over Pronto 7 monitor (Mass Device)
  • Senators Want More Companies to Pull Surgical Device From Market (WSJ-$)
  • FDA Rejects Ex-Staffer's Call To Pull Lasik Devices (Law 360-$)
  • FDA Seeks Feedback On Brain-Computer Interface Devices For Amputees (Gray Sheet-$)
  • Advancing Regulatory Science to Bring Novel Medical Devices for Use in Emergency Care to Market: The Role of the FDA (Annals of Emergency Medicine-$)
  • FDA Issues Small Medical Device Entity Compliance Guide for UDI and GUDID (FDA Life)

US: Dietary Supplements

  • Gap in Food-Safety Leadership Grows as FDA Hunts for Permanent Supplement Chief (NPI)
  • What’s in your energy drink? Even manufacturers may not know! (Quality Matters)
  • USPlabs Executives Gain Small Victory in Lingering Court Battle over Supplements (NPI)
  • FDA Recommends At Least 3 Servings Of Foods With Word ‘Fruit’ On Box (The Onion-Satire)

US: Assorted And Government

  • Physician Payments Sunshine Act: CMS Extends Dispute Window to September 8; Data Will Go Live September 30 (Policy and Medicine)
  • CMS Rejects 1/3 Of Sunshine Act Disclosures, Threatens Fines  (Law 360-$)
  • PCORI Offers Up to $90 Million in Funding in Third Call for Large Pragmatic Studies Proposals (PCORI) (Mass Device)
  • Doctors press extension to physician database deadline (The Hill) (Pharmalot)
  • Report: CDC Scientist Kept Quiet About Flu Blunder (AP) (WaPo) (Reuters) (CDC) (SCRIP-$)
  • AquaBounty’s H1 loss widens as FDA approval process drags on (RTT)
  • Food additives on the rise as FDA scrutiny wanes (WaPo) (WLF)

Ebola Outbreak

  • The Federal Government’s Inconsistent Ebola Story (Morning Consult)
  • Who Gets Ebola Drugs? AIDS, Dialysis and Cancer 'Cures' Point the Way (NBC)
  • Experts question protocol in using experimental Ebola drug (Modern Healthcare)
  • 3 Liberian Health Workers With Ebola Receive Scarce Drug After Appeals to U.S. (NYTimes) (Reuters)
  • Focus on Ebola: New Strategies in Discovery and Design of Therapies Against the Lethal Disease (Reuters)
  • Ebolanomics (New Yorker)
  • Imported Anti-Ebola Drug Turned Out To Be Pesticide (Spy Ghana) (All Africa) (Sahara Reporters)
  • Globavir Seeking Approval and Launch of Novel Ebola Treatment Before Year End (Press)

Europe

India

  • Exporters ask DoP to make India a member country of PICS to overcome hurdles in these countries (PharmaBiz)
  • Indian Health Ministry seeking compulsory license for B-MS’ Sprycel (Pharma Letter-$)
  • Patent controller issues revised “draft guidelines for examination of patent applications in the field of pharmaceuticals” (PharmaBiz)
  • Vaccines, Biosimilars In Shadow As Sun Shines On Ranbaxy? (PharmAsia-$)
  • Gujarat FDCA wants state govt to allot funds for setting up new drug regulatory offices in 7 new districts (PharmaBiz)
  • Rise in ex-parte orders upset generic drugmakers' future business plans (India Times)

China

  • Chinese trials could face more bureaucracy (BioCentury) (PharmAsia-$)
  • Pharma Exec Accuses CFDA Officials Of Favoritism (PharmAsia-$)
  • A forewarning for global medical device makers: China is pushing to grow its own device industry (MedCity News)

Canada

  • Health Canada toughening prescription-narcotic warning labels to combat abuse (National Post)
  • Apotex recalls one lot of organ rejection drug due to label error (Reuters)

Australia

  • Doubts lead Australia's TGA to take stock of CE-marking by 8 EU notified bodies (Clinica-$)

Other International

  • Proposal to expand the quality control of medicines sold in Brazil (Pharma Letter-$)
  • Sanofi and PATH launch large-scale malaria drug production (Pharmfile)
  • A Clash of Religion and Bioethics Complicates Organ Donation in Israel (NYTimes) (

Clinical Trials

  • NCI launches second precision medicine master protocol (BioCentury)
  • Building An Outcomes Trial ‘Firewall’: Who Knows What, When (Pink Sheet-$)
  • mHealth Poised to Transform Clinical Trials (Applied Clinical Trials)
  • The Nissen/Fleming Solution For ‘Firewalled’ CV Data Disclosures (Pink Sheet-$)
  • Neoadjuvant Trials Could Speed Up Drug Approvals (Oxford-$)
  • Adverse event reporting in non-pharmacologic, non-interventional pain clinical trials: ACTTION systematic review (Pain-$)
  • Bioethics Commission to Hold Public Meeting to Continue Discussions about Neuroscience and Related Ethical Issues (PCSBI)

General Regulatory And Interesting Articles

  • Extreme medicine: The search for new antibiotics (Reuters)
  • Fake Cures For AIDS Have A Long And Dreadful History (NPR)
  • Do gut bacteria rule our minds? (Press)
  • 'Plantibodies' drugs advance as big pharma stands aside (Reuters)
  • NSAIDs tied to reduced breast cancer recurrence among obese (Reuters)

Regulatory Reconnaissance #381 – 19 August 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 news@raps.org.

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


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