Regulatory Reconnaissance (14 March 2013)

Posted 14 March 2013 | By Alexander Gaffney, RAC 

Good morning and welcome to another edition of Regulatory Reconnaissance. If you're a regulatory intelligence professional, you probably use RSS feeds. Google announced yesterday it is ending support for Google Reader, the most popular of all readers. We recommend you try Feedly.

In the US, FTC comes out in support of generics companies regarding the use of REMS, the drug lobby looks to keep user fees away from the sequester, J&J's hip implant trial gets interesting, the Senate plans to hold a meeting on animal drug user fees, KV Pharmaceuticals is back in the courts and suing FDA, and a new leader of OIRA emerges.

Abroad, EMA's user fees are going up, legislators evaluate a series of proposals for overhauling clinical trials, EMA adopts four VICH standards, Novo Nordisk joins ABPI, CDSCO has a new mission statement, India's drug policies get blasted by US companies, and a Ghananian company fights back against quality concerns.

Five in Focus:

  1. EMA User Fees Will go Up At Rate of Inflation (EUR Lex)
  2. Initial appraisal of a European Commission Impact Assessment European Commission proposal on clinical trials (ENVI)
  3. FTC Amicus Brief: Improper Use of REMS Programs May Impede Generic Competition (FTC) (FDA Law Blog) (GPhA Brief) (GPhA Statement) (Pharmalot)
  4. Drug lobby presses President, Congress to return sequestered user fees to FDA (NYTimes)
  5. J&J's Ekdahl Says Hip Recalled for Clinical Reasons (Bloomberg)


Sequester & Budget
  • Pay freeze likely through 2013; unions blast House 2014 budget (Federal Times)
  • Drug lobby presses President, Congress to return sequestered user fees to FDA (NYTimes)
  • FTC Amicus Brief: Improper Use of Restricted Drug Distribution Programs May Impede Generic Competition (FTC) (FDA Law Blog) (GPhA Brief) (GPhA Statement) (Pharmalot)
  • Meetings: Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee (FDA)
  • Senate Meeting on 20 March 2013 to Discuss AGDUFA/ADUFA User Fee Legislation (HELP Committee)
  • KV Says "Heckler/Chaney Defense" is Inapplicable in Appeal Concerning Compounded 17P and Orphan Drug MAKENA (FDA Law Blog)
  • Generic Labels Must Reflect Current FDA Labeling Rules, D.C. Circuit Court Says (Lexis Nexis)
  • Hard to find good info on drug safety in pregnancy (AP)
  • Warning Letter to Compounder Medi-Fare Drug and Home Health Center 3/7/13 (FDA) (483)
  • FDA Officials Calm Concerns Over Excessive Bleeding With Dabigatran (CardioBrief)
  • House Trade Committee Focus on India (PhRMA)
  • Neurologists warn against prescribing ADHD drugs to kids as "study drugs" (CBS)
  • Keating, Ky. congressman to propose new painkiller legislation (The Herald News)
  • FDA to Petitioner: Geref (sermorelin acetate) was not withdrawn from sale for reasons of safety or effectiveness, can stay in Orange Book (FDA)
  • Firefighting group to FDA: Don't Make AEDs a Class III Medical Device (FDA)
  • "Defective" Complaint Triggers 30-Month Stay Against Mylan (Orange Book Blog)
  • Biogen submits haemophilia A drug to FDA (Pharma Times)
Medical Devices
  • J&J's Ekdahl Says Hip Recalled for Clinical Reasons (Bloomberg)
  • Could US FDA's Home Use Device Guidance Lead to a Slippery Regulatory Slope? (Medtech Insider)
  • Satiety Inc. escapes stomach stapling lawsuit (Mass Device)
  • HFES 2013 and What FDA Doesn't Want to See: Adventures in Medical Device Usability (MDDI)
  • Breathometer unveils the first smartphone breathalyzer, awaits FDA approval (Med City News)
  • Merck Partners with Luminex for Alzheimer's Diagnostic Device (New York Business Journal)
  • Vivus launches Qsymia weight-loss app (MM&M)
  • What are the chances of FDA approval for Boston Scientific's Watchman Heart Device? (MDDI)
  • Wanted: FDA App Enforcement (MDDI)
  • Novartis offers patients two new apps, removes VaxTrak (Mobi Health News)
  • H.R.1146 - To amend the Public Health Service Act and title XVIII of the Social Security Act to make the provision of technical services for medical imaging examinations and radiation therapy treatments safer, more accurate, and less costly (Congress)
  • AAMI/FDA International Standards Conference Convenes Next Week (AAMI)
  • A Key FDA Resource for Industry and the Public: Working with the FDA Office of the Ombudsman (FDA)
  • Obama administration reveals new leader of regulatory office (The Hill)
  • Expanding Medicare's Rx Abuse Controls Beyond Opioids Is Premature, Diverse Groups Tell CMS (The Pink Sheet Daily) ($)
  • Physician Payment Sunshine: ProPublica Updates Dollars for Doctors Database for 2013 (Policy and Medicine)
  • FDA Basics Metrics: February 2013 (FDA)
  • Congressman Neal Honored as BIO Legislator of the Year (Fort Mill Times)
  • Proposed Legislation in the 113th Congress (Eye on FDA)
  • Former J&J CEO and chairman Bill Weldon gets $29.8 million for 2012 (Philly Pharma)
  • Reps. Issa, Cummings Unveil FOIA Oversight and Implementation Act (House)
  • Fair and Immediate Release of Generic Drugs Act (Scout)
  • Indiana Senate Passes Biosimilars Interchangeability Bill (Scout)
  • Has The Pendulum Swung Too Far in Favor of Rare Diseases? (Xconomy)
  • FDA-Supported CTTI hosts second workshop in series, "Quality Risk Management: Understanding What Matters in Clinical Trials" (CTTI)


  • EMA User Fees Will go Up At Rate of Inflation (EUR Lex)
  • India to Establish Committees to Help Regulate Trials and Drug Approvals (Outsourcing Pharma)
  • U.S. groups criticize India drug, tech, farm policies (Reuters)
  • Grieving husband pushes UK bill for unproven remedies (Boston Herald)
  • Initial appraisal of a European Commission Impact Assessment European Commission proposal on clinical trials (ENVI)
  • European Ombudsman, P. Nikiforos Diamandouros, announces his retirement (Europa)
  • CDSCO's New Mission Statement (CDSCO)
  • India's DCGI plans to meet with industry more frequently (CDSCO)
  • Novo Nordisk joins ABPI ranks (Pharma Times)
  • China: Electromagnetic compatibility standard YY 0505-2012 of medical electrical equipment issued (SFDA)
  • Reflection paper on the data requirements for intravenous liposomal products developed with reference to an innovator liposomal product (EMA)
  • VICH GL51: Quality: statistical evaluation of stability data (EMA)
  • VICH GL34: Biologicals: testing for the detection of Mycoplasma contamination (EMA)
  • VICH GL35: Pharmacovigilance: electronic standards for transfer of data (EMA)
  • VICH GL50: Biologicals: harmonization of criteria to waive target animal batch safety testing for inactivated vaccines for veterinary use (EMA)
  • Zoll wins German patent battle over intravascular temperature management tech (Fierce Medical Devices)
  • Lymens challenges FDA fake drug allegations (Joy Online)
  • New Chair sought for the British Pharmacopoeia Commission (MHRA)
  • French Regulators Warn that DI-HYDAN stocks may experience shortages, can be substituted with Diphantoine (ANSM)


  • What's to be done to reduce the high turnover rate for clinical trial investigators? (Med City News)
  • Direct to Consumer Advertising May Lead to Over-Diagnosis (Eye for Pharma)
  • Medical device prostheses have come a long way in the last few years (Imgur)
  • Yale University Researchers Trick Bacteria to Deliver a Safer Vaccine (BioSpace)
  • Tapeworm genome points way to better drug treatments (Reuters)

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.

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