Regulatory Focus™ > News Articles > Regulatory Reconnaissance (25 March 2013)

Regulatory Reconnaissance (25 March 2013)

Posted 25 March 2013 | By Alexander Gaffney, RAC

Good morning and welcome to another edition of Regulatory Reconnaissance.

In the US, the Supreme Court hears a case on pay-for-delay deals today, United Therapeutics' Remodulin gets another FDA rejection letter, a court sides with FDA and requires Cytori Therapeutics to submit a PMA, AstraZeneca settles a lawsuit with Watson regarding its cholesterol drug Crestor, FDA gives its approval to four generic versions of Diovan, DEA says it hopes FDA implements a new labeling standard for opioids, FDA gives $800,000 to a company for social media adverse event reporting, FTC's Julius Genachowski plans to step down soon, and GE loses a $5 million verdict over a adverse reaction.

Abroad, Japan approves a huge number of drug products, new approvals out from the CHMP show a divergence from FDA, one expert thinks fewer EU notified bodies could cost manufacturers a lot of money, and some say former EU health commissioner John Dalli was ousted using information obtained illegally.

Plus: Cough syrup sure has changed a lot of the years. Former ingredients include alcohol, cannabis, chloroform and morphine.

Five in Focus:

  1. Today: Justices to Look at Deals by Generic and Branded Drug Makers (NYTimes)
  2. Cytori Therapeutics loses appeal on fast-track approval for stem cell products (Reuters) (Bloomberg) (AP) (FDA Law Blog) (DC Circuit)
  3. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 March 2013 (EMA)
  4. DEA Citizen Petition: We Hope FDA Implements New Labeling Regulations for Opioids (DEA)
  5. FDA Makes $800,000 Award to Company to Mine Social Media for Adverse Event Surveillance (FDA) (Epidemico) (Their App)


  • Justices to Look at Deals by Generic and Branded Drug Makers (NYTimes)
  • Strike two: FDA hands United Therapeutics another rejection on oral Remodulin (Fierce Biotech) (Market Watch)
  • AstraZeneca settles legal dispute with Watson Laboratories (AP) (Pharma Times) (AstraZeneca)
  • Inspection report details ongoing problems at Hospira (Fierce Pharma)
  • FDA Makes $800,000 Award to Company to Mine Social Media for Adverse Event Surveillance (FDA) (Epidemico) (Their App)
  • FDA Approves Four Generic Versions of Diovan (Valsartan Hydrochlorothiazide) by Lupin, Watson, Alembic and Aurobindo (Drugs@FDA)
  • DEA Citizen Petition: We Hope FDA Implements New Labeling Regulations for Opioids (DEA)
  • DEA Places Alfaxalone into Schedule IV under Controlled Substances Act (DEA)
  • Text of ADUFA/AGDUFA Now Online (SCOUT)
  • Pharmaceutical Quality And Generic Drugs: Janet Woodcock Explains Her Vision (The Pink Sheet) ($)
  • Drug Shortage for Bedford's Phentolamine Mesylate Resolved (FDA)
  • Pharmacists Express Concerns with Sen. Casey's Proposal to Restrict Access to Cough Medication (NCPA)
  • Cerulean Pharma's lead nanodrug crashes in lung cancer study (Fierce Biotech)
  • New Study Underscores Increased Dangers of Certain Diabetes Treatments (Public Citizen)
  • ASHP Provides Recommendations to the FDA for the Drug Shortages Strategic Plan (ASHP)
  • L.A. County Sheriff's, FDA serve search warrants in three county raid (LA Daily News)
  • Theravance Seen Luring Glaxo Bid as Drugs Near FDA Nod: Real M&A (Bloomberg)
  • Study: Docs Seem to Miss FDA Epilepsy Text Alerts (Med Page Today)
  • Senators introduce bill restricting sale of DXM cough-relieving ingredient to adults (Drug Store News)
  • Senator Schumer urges FDA to help prevent prescription drug abuse (PIX11)
  • 2 Can't-Miss FDA Rulings Next Week (Motley Fool)
  • Determination That BENADRYL (diphenhydramine hydrochloride) Injection and Two Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness (FDA)
  • New Animal Drug Approvals; Change of Sponsor; Change of Sponsor's Drug Labeler Code; Gonadorelin Acetate; Isoflurane; Praziquantel; Propofol; Sevoflurane; Triamcinolone Acetonide (FDA)
  • New Animal Drugs: Sponsor Changes (FDA)
  • Illinois Bill Would Allow a Class II Substance to be Dispensed in 90-Day Amounts (SCOUT)
  • Are Your Drugs Exempt From The California Pedigree Law? (RxTrace)
  • FDA's Hand-Held Rx Counterfeit Detector Could Roll Out To Developing Nations (The Pink Sheet) ($)
  • Biosimilars Lure Major Drugmakers Into the Generics Biz (Bloomberg Businessweek)
  • NIAID's Anthony Fauci: FDA Has a Role in Advancing Universal Flu Vaccine "Right from the beginning." (BioCenturyTV)
Medical Devices
  • Cytori Therapeutics loses appeal on fast-track approval for stem cell products (Reuters) (Bloomberg) (AP) (FDA Law Blog) (DC Circuit)
  • Accessible Medical Device Labeling in a Standard Content and Format Public Workshop; Extension of Comment Period (FDA)
  • Device Interoperability Standards-Setting Effort Aims For Extensive Stakeholder Input (The Gray Sheet) ($)
  • FDA Plans To Audit Its New 510(k) Refuse-To-Accept Program (The Gray Sheet) ($)
  • FDA Approves GE Healthcare's AdreView™ (Iobenguane I 123 Injection) for Cardiac Risk Evaluation in Heart Failure Patients (GE)
  • GE Unit Loses $5 Million Verdict Over Dye Damage to Skin (Bloomberg)
  • Premarket Approval of Resolute Integrity Zotarolimus-Eluting Coronary Stent System P110013/S005 (FDA)
  • Medical device companies likelier to win permanent injunctions in patent cases (Mobi Health News)
  • Medical-Device Tax Repeal Faces Uphill Climb in Senate (WSJ)
  • Backed by Hatch, Klobuchar, medical device makers score victory (Sunlight Foundation)
  • FTC Chairman Genachowski Announces Plans to Step Down In Coming Weeks (FTC)
  • PRACS study subjects left hanging after company declares bankruptcy (Dickinson Press)
  • Washington Health Agencies Are Practicing Medicine: The Case Of A Sick Heart (Forbes)
  • Durbin's move to reintroduce labeling bill called 'misguided' (Nutraingredients USA)
  • 90 Percent Of The U.S. Kids Who Died From The Flu This Year Didn't Get Their Vaccinations (Think Progress)
  • Close Contact With FDA District Office Played Key Role in Resolving Nexgen Warning (FDA News)
  • DOJ Charges Woman With Knowingly Distributing Counterfeit Forms of Birth Control (DOJ)
  • ePharmaSolutions and CenterWatch Partner to Improve Patient Eligibility and Access to Clinical Trials (Center Watch)
Government and Budget
  • Dozens of amendments demonstrate GOP ire over regulations (The Hill)
  • Understanding the FY13 Full-Year Continuing Resolution Bill (Alliance for a Stronger FDA)
  • Senate budget 'vote-a-rama' winds down (The Hill)
  • Budget Amendments Would Threaten Public Protections; Coalition Urges Lawmakers to Oppose Attack on Regulations (Public Citizen)
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)
  • 27-28 March 2013: Public Meeting on the Food Safety Modernization Act (FSMA) (FDA)


  • Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 March 2013 (EMA)
  • Reflection paper on the data requirements for intravenous liposomal products developed with reference to an innovator liposomal product (EMA)
  • Fewer EU Notified Bodies Could Cost Manufacturers Thousands (FDA News)
  • Ariad's Iclusig Cleared For European Approval By CHMP (The Pink Sheet Daily) ($)
  • Bayer's Xarelto® (Rivaroxaban) Recommended for Approval in the EU for the Prevention of Atherothrombotic Events after an ACS (Bayer)
  • CHMP And FDA Diverge On Mipomersen And Rivaroxaban (CardioBrief)
  • Doubt over Sanofi drug in EU may hurt wider MS market (Reuters)
  • Baxter and Halozyme Announce Positive CHMP Opinion for HyQvia for Treatment of Primary and Secondary Immunodeficiencies (Baxter)
  • Roche says Japan approves new formulation of arthritis drug (Reuters)
  • Daiichi Sankyo Receives Approval in Japan for Manufacture and Marketing of PRALIA, a New Treatment for Osteoporosis (Daiichi Sankyo)
  • Daiichi Sankyo Receives Approval from MHLW for Additional Indication of Anticancer Agent Topotecin Intravenous Drip Infusion (Daiichi Sankyo)
  • Astellas Receives Approval in Japan for Treating Functional Dyspepsia with Acofide (Astellas)
  • Otsuka Obtains Marketing Approval in Japan for Onglyza Tablets to Treat Type 2 Diabetes;
  • Transferred Rights to Kyowa Hakko Kirin (Otsuka Pharmaceutical)
  • Eisai Receives Manufacturing and Marketing Authorization for Antipileptic Agent Inovelon in Japan (Eisai)
  • Changes to medical device registration in Egypt announced (Mass Device)
  • Revised Excipient Information Package Guidance Now Published (IPEC)
  • MHRA Updates its Periodic Fees List for 1 April 2013 Onward (MHRA)
  • OLAF accused of using 'illegal means' in Dalligate probe (EuroActiv)
  • Upcoming drug pricing policy: Essential drug makers can no longer quit without informing govt (The Economic Times)
  • Compensation hopes for faulty hip implant victims in Australia (SMH)
  • Philippines FDA warns public vs 3 'anti-cancer' products (Philippines Star)
  • Gujarat FDCA to launch India's first mobile drug testing lab in state soon (PharmaBiz)
  • India: Tamil Nadu Drug Control Dept plans to release test results of drug samples in a month's time (PharmaBiz)

General Regulatory and Interesting Articles

  • Chipping away at animal testing (Boston Herald)
  • Science Fiction Comes Alive as Researchers Grow Organs in Lab (WSJ)
  • Cough syrup sure has changed over the years… (Imgur)
  • Pathologists identify patterns of mutations to help inform design of future trials (EurekaAlert)
  • NYU Student Creates Healing Gel To Stop Bleeding (Huffington Post)
  • How Health Research Misdirects Us (The Atlantic)
  • The Immortal Life of Henrietta Lacks, the Sequel (NYTimes)
  • New chemo drug gentler on fertility, tougher on cancer  (EurekAlert))
  • Wow of the Week: Clinical trial matchmaker wants to disrupt clinical trial recruitment with access to data (Med City News)
  • How An Unlikely Drug Helps Some Children Consumed By Fear (NPR)

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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