Regulatory Focus™ > News Articles > Regulatory Reconnaissance (22 February 2013)

Regulatory Reconnaissance (22 February 2013)

Posted 22 February 2013 | By Alexander Gaffney, RAC

Good morning and welcome to another edition of Regulatory Reconnaissance. Just seven days remain until budget sequester cuts come into effect. The Washington Post reports that most agencies would furlough workers' pay by 20%. Could some FDA staff head for the exits in the face of such draconian cuts?

In the US, the Congressional Budget Office is out with new estimates for an important regulatory bill, FDA has a new policy for naming certain drug products, FDA is developing a new health IT framework, GSK is getting sued by the state of Maryland for alleged false advertising, and the FBI has "declared war" against ubiquitous wheelchair sales company The Scooter Store. Internationally, Vivus' diet pill gets stonewalled by regulators in the EU, TGA's 2013 blueprint is out, the Dutch are launching their own Sunshine Act, and new EMA guidance on how to conduct pharmacovigilance when the world's falling apart.


  • FDA Announces Start of Development of Health IT Regulatory Framework (FDA)
  • Ex-NIH Director Elias Zerhouni: Sequester Will Set Medical Research Back a Generation (Washington Post)
  • Budget cuts could result in up to 20 percent pay cut for federal workers (Washington Post)
  • CMS Launches a Website and Templates for Sunshine Reporting (Pharma Compliance Blog)
  • FDA MAPP: Naming of Drug Products Containing Salt Drug Substances (FDA)
  • Impax Citizen Petition Claims That Endo's Petition Doesn't Show That Non-Abuse Resistant Opana Was Withdrawn for Safety Reasons (Impax Petition) (Background via Regulatory Focus)
  • State AG sues maker of diabetes drugs for false advertising (Baltimore Sun)
  • FBI Declares War on The Scooter Store (The Atlantic)
  • Epilepsy Device Gets High Marks from FDA Staff (Medpage Today)
  • The Congressional Budget Office Just Scored the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 as costing $11 billion through 2018 (CBO)
  • Abiomed gets out from under FDA's Impella warning letter (Fierce Medical Devices)
  • Transmissible Spongiform Encephalopathies Advisory Committee Meeting (14 March 2013) (FDA)
  • FDA has Granted an Patent Term Extension for Edward's Sapien Transcatheter Heart Valve (FDA)
  • Gentium shares wrecked by fresh round of regulatory woes for lead drug (Fierce Biotech)
  • Chinese cyberspies have hacked most Washington institutions, experts say (Washington Post)
  • Lobbyists Pack Florida House Meeting to Discuss Bill Limiting Generic Drug Use (The Ledger)
  • Intended Use Claims- Regulatory Ambiguity Limits Meaningful Education and Disease Management (mHealth Regulatory Coalition)
  • Critical Path Institute, FDA-Supported Regulatory Standards Group, Just Appointed a New CEO (C-Path)
  • GPhA Scolds Genentech, Amgen for Fighting Against Biosimilar Substitution (The Pink Sheet) ($)
  • Medicines quality workshop to address standards for microbiological contamination, bioburden control (USP)
  • Warning Letter: Supplement Manufacturer Beehive Botanicals Hit for CGMP Violations (FDA)
  • Experts issue guidelines for gene tests in kids (Reuters)
  • Repros jumps on FDA go-ahead for testosterone drug study (Reuters)
  • Consent for online research calls for transparency, innovation (Fierce Health IT)
  • FDA/CDER Response to The Weinberg Group Inc - Denial of Reconsideration. Generic drug had different route of administration, FDA claims they need clinical testing. (FDA)
  • Flu vaccine worked in just over half of Americans who got it (Reuters)
  • Drug shortages play role in growth at West Pharmaceutical (Fierce Pharma Manufacturing)
  • Abbott inks companion Dx deal for J&J's 'breakthrough' cancer drug (Fierce Medical Device) (Reuters) (Abbott)
  • FTC's Interest in Mobile Apps Intensifies (FDA Law Blog)
  • NIH Announces New Guidelines for Risky Research (Nature)
  • Morning-After Pills Don't Cause Abortion, Studies Say (NPR)
  • N.Y. may require masks for unvaccinated (UPI)
  • Flu vaccine nearly useless for elderly (UPI) (NPR)
  • Medicare drug costs to fall in 2014, but donut hole widens (Reuters)
  • NYTimes Editorial Board Op-Ed: Making Some Painkillers Harder to Get (NY Times)
  • Brookings Workshop: Payer Involvement in the Sentinel Initiative (Brookings)
  • Inspector General Levinson to Outline Fraud Enforcement Initiatives at Health Care Compliance Association Event in April (OIG)
  • Major Doctor Group Coalition Expands List Of Overused Tests, Treatments (Kaiser Health News)
  • What Drug Manufacturers Need to Know About 340B in 2013 (Covington & Burling LLP)
  • Medicare Program; Medical Loss Ratio Requirements for the Medicare Advantage and the Medicare Prescription Drug Benefit Programs (CMS)
  • High-priced drug for rare extreme cholesterol condition leaves insurers wary (Philadelphia Enquirer)


  • FDA-approved obesity drug stalled in Europe (Reuters) (BioCentury) (EMA)
  • EU agency recommends Sanofi, Merck pediatric vaccine (Reuters)
  • Public consultation opens on standard paediatric investigation plans for two types of cancer in children (EMA)
  • Reflection paper on good-clinical-practice compliance in relation to trial master files (paper and / or electronic) for management, audit and inspection of clinical trials (EMA)
  • TGA reforms: A blueprint for TGA's future: Progress report as at 31 December 2012 (TGA)
  • Distant/virtual pharmacovigilance inspections of MAHs during a crisis situation- Points to consider (EMA)
  • German cost agency spurns Xalkori, Komboglyze (Fierce Pharma)
  • Dutch launching transparency register for financial ties (BioCentury)
  • Upcoming EMA Training Session on eSubmission Gateway (5 March 2013) (EMA)
  • Gentium expects EMA rejection for defibrotide (PM Live)
  • EC approves Adasuve (BioCentury) (PM Live)
  • Pharma should not publish raw data, says former ABPI head (Pharma Times)
  • Registration now open for the MHRA's 8th Annual Lecture, London, 11 March 2013 (MHRA)


  • Bitter Pill: Why Medical Bills Are Killing Us (CNN) (Video) (PhRMA Response)
  • The Robot Will See You Now (The Atlantic)
  • Resistance Rates Much Higher Than WHO Estimates (Lancet)
  • Rising vaccine prices mean fewer children immunized (Fierce Vaccines)
  • Former Peanut Firm Executives Indicted Over 2009 Salmonella Outbreak (NPR)
  • TruScan 'not robust enough for substandard drug detection' (Securing Industry)
  • The Whole Community Gets A Health Boost From HIV Treatment (NPR)
  • Google Hangout With Mass Device Staff Talking About Medical Device News (42:21) (Mass Device)

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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