Regulatory Focus™ > News Articles > Regulatory Reconnaissance (27 March 2013)

Regulatory Reconnaissance (27 March 2013)

Posted 27 March 2013 | By Alexander Gaffney, RAC

Good morning and welcome to another edition of Regulatory Reconnaissance.

In the US, two prominent senators are calling for the US' 12 years of biologics exclusivity to apply to other nations involved in a trade deal as well, FDA fast-tracks a plant inspection to deal with shortages, Public Citizen wants to ban some diabetes drugs, GSK's flu vaccine gets a CRL because of hesitancies over an adjuvant, J&J recalls millions of blood glucose meters, robotics surgery company Intuitive must face a patient death lawsuit, a CRO bankruptcy leaves many prominent biotechs out hanging, and senators want companies to stop advertising energy drinks-supplements, really-to kids.

Abroad, EMA completes work on the 2014 season flu vaccine recommendations, India's supreme court prepares to weigh in on an important patent, China's drug approval process stays the same even if its regulatory agency hasn't, EMA releases a new guideline on biological medicines labeling, NICE recommends against Xalkori, a Merck IUD gets hit with a recall, and EMA's final budget is published in the Eur-Lex.

Five in Focus:

  1. Senators Call for 12 Years of Biologics Exclusivity in Trade Deal (US Chamber of Commerce) (PhRMA)
  2. PRACS' CRO implosion leaves a Who's Who of biopharma creditors in its wake (Fierce Biotech)
  3. Latest FDA User Fee Bill Unlikely To Include Major Reforms (Law360) ($)
  4. NICE recommends against Xalkori (BioCentury) (Pharma Times)
  5. India's Supreme Court to Weigh in on Glivec Patent in April, Leaving Pharma Companies nervous (Economic Times)


  • Senators Call for 12 Years of Biologics Exclusivity in Trade Deal (US Chamber of Commerce) (PhRMA)
  • FDA fast-tracks plant for injectable on shortage list (Fierce Pharma Manufacturing)
  • Watchdog Wants FDA To Ban Some Diabetes Drugs (Pharmalot)
  • Drug Makers' Rising Interest in Injectables Could Ease Shortages (WSJ)
  • FDA Denies Approval For Glaxo Bird Flu Vaccine (Pharmalot) (GSK) (Reuters) (25 Mar)
  • FDA grants Acceleron drug 'orphan' status (Boston Herald)
  • Ziopharm cancer drug fails late-stage trial; shares plunge 66 percent (Reuters) (BioSpace) (Fierce Biotech)
  • Pfizer Manufacturing Issues Cause TB Injection Shortage, Discoloured Vials (Outsourcing Pharma)
  • Phytopharm slashes staff, scouts buyers after Parkinson's drug failure (Fierce Biotech)
  • FDA perspective published in the New England Journal of Medicinereinforces safety of Pradaxa® (dabigatran etexilate) (Boehringer Ingelheim)
  • FDA Approves ACIPHEX® Sprinkle™ (Rabeprazole Sodium) For Use in Children Ages 1 to 11 (Eisai)
  • Acceleron Receives Two FDA Orphan Designations For ACE-536 (Pharmaceutical Online)
  • FDA Approves ANDA for Signapharm Labs' Sodium Phenylbutyrate (FDA)
Medical Devices
  • J&J recalls nearly 2 million blood glucose meters worldwide (Reuters) (Bloomberg) (25 Mar)
  • Intuitive Surgical Loses Bid to Throw Out Robot Lawsuit (Bloomberg)
  • McConnell to House: Move Device Tax Repeal Soon (Roll Call)
  • After FDA's mobile medical apps final guidance, what's next? (Mobi Health News)
  • mHIMSS executives say FDA regulation won't hold back app innovation (Healthcare IT News)
  • BioControl Medical makes progress toward FDA review for CardioFit heart stim device (Mass Device)
  • Judge: Intuitive must face patient death lawsuit (Fierce Medical Devices)
  • Special Fraud Alert: Physician-Owned Entities and Implantable Medical Devices  (OIG) (Mass Device) (WSJ)
  • Cardinal Health DuraBlue Sterilization Wrap Gets New FDA Clearances (Infection Control Today)
  • PRACS' CRO implosion leaves a Who's Who of biopharma creditors in its wake (Fierce Biotech)
  • Explaining FDA's Caution on New Surrogates to New Patient Constituencies (RPM Report) ($)
  • 21 graphs that show America's health-care prices are ludicrous (Washington Post)
  • A social media manifesto (PharmaLive)
  • Agency Information Collection Activities; Proposals, Submissions, and Approvals Registration of Food Facilities under the Public Health Security and Bioterrorism Preparedness and Response Act (FDA)
  • An insider's view of generic-drug pricing (LA Times)
  • YouTube's Channels reboot gives pharmas pause (MM&M)
  • The Economics of Genomic Medicine - Workshop Summary (IOM)
  • PCORI Names 84 People From Across the Healthcare Community to Serve on its First Four Advisory Panels (PCORI)
  • Senators pressure energy drink makers to stop advertising to children (Food Chemical News)
  • 'Big Data' for Cancer Care: Vast Storehouse of Patient Records Will Let Doctors Search for Effective Treatment (WSJ)
Government and Budget
  • President Signs Budget Deal (White House)
  • Latest FDA User Fee Bill Unlikely To Include Major Reforms (Law360) ($)
Meetings This Week
  • 25 March 2013: FDA Webinar on Draft Guidance for Industry on Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products (FDA)
  • 25 March 25: Webinar Draft GFI On Enrichment Strategies For Clinical Trials To Support Approval Of Human Drugs And Biological Products (FDA)
  • 27-28 March 2013: Public Meeting on the Food Safety Modernization Act (FSMA) (FDA)
  • 28 March 2013: Webinar: Draft Guidance For Industry On Alzheimer's Disease: Developing Drugs For The Treatment Of Early Stage Disease (FDA)


  • European Medicines Agency issues recommendations for 2013/2014 seasonal flu vaccine composition (EMA)
  • Draft guideline on the declaration of the quantitative composition / labelling of biological medicinal products that contain modified proteins as active substance (EMA)
  • India's Supreme Court to Weigh in on Glivec Patent in April, Leaving Pharma Companies nervous (Economic Times)
  • China's Drug Approval Processes Unchanged In SFDA-CFDA Transition (PharmAsia News) ($)
  • India's Drug Regulator Releases an Unusual Message Offering Best Wishes for Holi (CDSCO)
  • Multiple sclerosis rivals gain EU approval (Pharmafile)
  • NICE recommends against Xalkori (BioCentury) (Pharma Times)
  • Contract Manufacturing Regulatory Approval Round-Up (Outsourcing Pharma)
  • Merck IUD lot hit with Hong Kong recall (Fierce Medical Devices)
  • India state ups effort to root out counterfeits (Fierce Pharma Manufacturing)
  • Ministry Of Internal Affairs Requests MHLW To Improve Hospital Side Effect Reporting (PharmaAsia News) ($)
  • Fujimoto And Celgene To Review Safety Management Procedures For Thalidomide And Revlimid (PharmAsia News) ($)
  • Canadian elderly have most drug reactions (UPI)
  • EMA reviewing empagliflozin MAA (BioCentury)
  • Australian pharma "caught in negative cycle" (Pharma Times)
  • Otsuka files new TB candidate in Japan as shortages worsen (PMLive)
  • Unannounced notified body visits recommendation imminent in EU (Medical Devices Legal)
  • Statement of revenue and expenditure of the Innovative Medicines Initiative Joint Undertaking for the financial year 2013 (Eur-Lex)
  • Statement of revenue and expenditure of the European Medicines Agency for the financial year 2013 (Eur-Lex)

General Regulatory and Interesting Articles

  • Goldacre versus pharma debate: Video online (Pharma Times)
  • Qualified Sites the Biggest Issue for Rare Disease Trials (Eye for Pharma)
  • Myriad model falls apart outside the US (Financial Times)
  • Indian goverment ties up with Abbot to combat non-communicable diseases (Economic Times)
  • EDTA chelation therapy modestly reduces cardiovascular events (NIH) (Forbes)
  • Antidepressants not tied to stunted infant growth (Reuters)
  • Study Says Flu Vaccine Linked to Narcolepsy in Under 30s (MedIndia)

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.

Did we miss a story? Send us a tweet at @RAPSorg or @AlecGaffney and we'll check it out for inclusion in our next edition of Regulatory Reconnaissance. Want this in your inbox each morning? Sign up for RF Today, our morning intelligence newsletter here.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.