Regulatory Reconnaissance (21 February 2013)

Posted 21 February 2013 | By Alexander Gaffney, RAC 

Good morning and welcome to another edition of Regulatory Reconnaissance. There are just eight days left until the effects of budget sequestration come into effect. On the hill, the top House legislator who oversees FDA thinks those cuts are inevitable.

Elsewhere in the US, the Senate has prepared a full committee hearing on animal drug user fees, FDA's top two Rx-to-OTC officials have resigned, and DHHS is out with new rules that could expand mental health coverage to tens of millions. Internationally, Roche and Novartis have been accused of cartel-like behavior, the battle for device regulation starts on 26 February, EU trials are being blamed for hindering child cancer progress, and an industry group is being asked to censure Roche for 'drunken antics.'


  • FDA Rx-To-OTC Switch Division Director Leonard-Segal Resigns (The Pink Sheet Daily) ($)
  • Senate Has Scheduled First Full Committee Hearing to Discuss Animal Drug User Fee Agreements for 27 February 2013 (HELP Committee)
  • Top Legislative Official in Charge of FDA: Sequester Inevitable (The Hill)
  • US issues final word on essential benefits under "Obamacare." 32M to Obtain Mental Health Coverage as a Result (Reuters) (NYTimes) (The Hill)
  • Pharmacists say drug disposal rule should include controlled substances (The Hill)
  • The First Ever "Dear Doctor" Letter Regarding a Mobile Medical App Recall (Pharma Marketing Blog)
  • Increased FDA Scrutiny Of Pre-Approval Communications Continued in 2012 (Sidley Austin)
  • Evaluation of PEPFAR Shows Expansion of Services, Ongoing Challenges (IOM)
  • US rejection of Novo drug seen temporary but costly (Reuters)
  • Chelsea says FDA allows Northera resubmission with existing data (Reuters)
  • Minutes of FDA meeting with Physicians for Responsible Opioid Prescribing (PROP) (FDA)
  • Meetings: Device Good Manufacturing Practice Advisory Committee (FDA)
  • Legislation: H.R.746 - To provide small businesses with a grace period for a regulatory violation, and for other purposes. (Congress) (Press)
  • House bill would exempt emergency medical devices from Obamacare tax (Mass Device)
  • Will New Recommendations From NIH Curb Use of the Animal Efficacy Rule? (FDA Law Blog) (Regulatory Focus)
  • Edwards Life Sciences CEO reflects on major product approval (Beaker's Blog)
  • Winners And Losers From The Zaltrap Price Discount: Unintended Consequences? (Health Affairs)
  • The Obama Administration's Former Regulatory Czar has Landed Back at Harvard (OIRA Watch)
  • Pharmacy Lobby Offers Suggestions to DEA on Drug Take-Back Programs (Drug Store News)
  • Pfizer demands rehearing in generic Reglan case (Fierce Pharma) (Pharmalot)
  • OIG finds Medicare could save millions on drugs infused via durable medical equipment (OIG)
  • Medicare patients choosing low-cost drug plans, analysis finds (The Hill)
  • De Novo Approval Letter for FerriScan R2-MRI Analysis System (FDA)
  • NIH pours $900K into Parkinson's biomarker research (Fierce Biomarkers)
  • NIH-funded researchers begin trial of Shigella vaccine candidates (NIH)
  • New findings from two studies support substantial benefit of Pradaxa® for prevention of recurrent deep vein thrombosis and pulmonary embolism (Boehringer Ingelheim)
  • HRSA is out With New Estimates for its 340B Audit Program (HRSA)
  • NIH Amends Research Guidelines in Response to Recombinant DNA Research With Potential to Make Pandemic Flu More Virulent (NIH)
  • Nominations to the Advisory Committee on Blood and Tissue Safety and Availability (DHHS)


  • Tougher EU device regs? The battle begins in earnest on Feb. 26 (Fierce Medical Devices) (ENVI)
  • Italy Probes Roche & Novartis For Forming A 'Cartel' (Pharmalot) (PM Live)
  • Germany's IQWiG Pans Pfizer's Xalkori On Study Results, Side Effects (The Pink Sheet Daily)
  • Trials regulation hindering child cancer progress, say experts (Pharma Times)
  • European pharma patent court deal sealed (PM Live)
  • Stryker recommends more vigilant monitoring of patients with recalled hip implants (Mass Device)
  • MEDEC analysis: Increased review times at Health Canada (Mass Device)
  • India's CDSCO introduces pre-screening of applications for registration of ECs (PharmaBiz)
  • Indian Industry Group NPPA opposes track and trace system for pharma products for domestic supply chain (PharmaBiz)
  • Responses to the concept paper on a common logo for legally-operating online pharmacies/retailers offering medicinal products (European Commission)
  • WHO Pharmaceuticals Newsletter for January 2013 (WHO)
  • Report: Sense That UK Supply Of Innovative New Pharma Drugs Is Drying Up a "Myth" (Medical News Today)


  • Roche censured for drunken conference antics (Pharmafile) (Pharmalot)
  • Must-Know Standards and Tests for Wireless Medical Devices (MD+DI)
  • Tamiflu: Myth and Misconception (The Atlantic)
  • A Doctor Can Finally Tell Fresenius: 'I Told You So' (Pharmalot)
  • Print Me An Ear: 3-D Printing Tackles Human Cartilage (NPR)
  • Eleven Medical Researchers Each Collect $3 Million Research Prize Funded by Google, Facebook Founders (NYTimes)

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.

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