Regulatory Focus™ > News Articles > Regulatory Reconnaissance (19 March 2013)

Regulatory Reconnaissance (19 March 2013)

Posted 19 March 2013 | By Alexander Gaffney, RAC

Good morning and welcome to another edition of Regulatory Reconnaissance. It's a big day for the US pharmaceutical industry, as the Supreme Court is set to hear arguments today regarding liability for safety problems found in generic drug products.

In the US, off-label use of an anti-drowsiness drug skyrockets, FDA review staff aren't keen on an Abbott heart device, CDER's expectations for process monitoring are increasing, Novartis scores another breakthrough designation, Pharmaxis is asked to conduct another CF drug trial, the eCopy program could be off to a rocky start, and details emerge about an $80 million drug heist.

Abroad, Swedish regulators think a press release constitutes DTC advertising, more details on a second Indian company seeking a compulsory license, Ukrainian regulators want to combine the regulatory and reimbursement processes, the EU moves toward an adaptive licensing system, an agency is assessing the safety of five chemicals used in pharmaceutical manufacturing, and Australia says its seeing a jump in counterfeit medicines.

Five in Focus:

  1. Supreme Court to Hear Generics Drugmaker Liability Case Today (Reuters) (Politico)
  2. Is A Press Release Really An Ad? Ask Boehringer (Pharmalot)
  3. FDA staff does not recommend approval of Abbott's heart device (Reuters) (FDA) (Fierce Medical Devices)
  4. Indian co seeks compulsory licence for cancer drug of Bristol Myers (PharmaBiz)
  5. Ukranian Health Ministry wants pharmaceutical companies to declare price of medicine during their registration (Kyiv Post)

US

Pharmaceuticals/Biotechnology
  • Supreme Court to Hear Generics Drugmaker Liability Case Today (Reuters)
  • "Off-label" use of anti-drowsiness drug skyrockets (Reuters)
  • CDER Ratcheting Up Expectations for Process Monitoring: Official (FDA News)
  • FDA deems Novartis lung cancer drug a "breakthrough therapy" (PM Live) (Fierce Pharma) (BioCentury)
  • Former FDAer Gottlieb: Court case could undermine drug approval process (Politico)
  • What to Watch: NPC Webinar on Comparative Effectiveness (19 March) (PhRMA)
  • FDA Approved ANDA for Generic Xopenex (Levabuterol Hydrochloride) (Drugs@FDA)
  • Criminal investigations for counterfeit, diverted drugs skyrocketed in 2012 (Pharmaceutical Commerce)
  • Mistrial Declared in Fosamax (alendronate sodium) New Jersey State Court Trial (Merck)
  • FDA asks Pharmaxis for another CF trial  (The Australian) (PharmAsia News)
  • Medicis Pharma Petitions FDA to Reverse Suitability Petition of Generic Competitor (FDA)
Medical Devices
  • FDA staff does not recommend approval of Abbott's heart device (Reuters) (FDA) (Fierce Medical Devices)
  • Bumpy Start to the eCopy Program for Device Submissions? (imarc)
  • Abbott's Minimally Invasive Mitral Repair Device May Have Hit FDA Speed Bump. Can Other Companies Prevail? (MDDI)
  • Cardiovascular Systems completes PMA submission (Fierce Medical Devices)
  • Thoratec touts 1st human use for catheter-based HeartMate PHP heart pump (Mass Device)
  • Syncardia nabs 2 Humanitarian Use Device wins for its smaller artificial heart (Mass Device)
  • Symbios Medical Surgical Pain Pump Recalled Because of Flow Problems Potentially Resulting in Death (FDA)
  • Guardian hemostasis valves under Class I recall (Cardiovascular Business)
Assorted
  • Does the involvement of US Taxpayers in Helping Discover a Drug Mean They Should Receive it at a Discounted Rate? (NYTimes)
  • AstraZeneca to Cut Jobs in R&D Restructure (WSJ) (Fierce Biotech)
  • FDA Updates its Adverse Event Reporting System (FAERS) Database for Q3 2012 Data (FDA)
  • Hollywood-style caper in $80M theft obtained security plans to get inside (NJ Star Ledger)
  • Patient Group Looking to Petition White House on Hepatitis C Drug Candidate Dropped by BMS/Gilead. Seeks Facilitated "Cooperation" (HCV Coalition for the Cure) (Background)
  • U.S. Drug Costs Dropped in 2012, but Rises Loom (NYTimes)
  • PCORI Patient-Researcher Matching Challenge (Health 2.0)
  • Digestive Products Face Regulatory, Marketing and Research Challenges (Natural Products Insider)
  • FDA Uses Portable Rapid Testing Devices To Insure Patient Safety (Partnership for Safe Medicines)
  • Personalized medicine patents at risk: tips for battling Prometheus and Myriad to obtain claims to diagnostics (Lexology)
  • OMB Completes Review of Guidance: Emergency Use Authorization of Medical Products (OMB)
Meetings This Week
  • March 20, 2013: Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting Announcement (FDA) (Meeting Materials)
  • March 21, 2013: Meeting of the Psychopharmacologic Drugs Advisory Committee Meeting Announcement (FDA)
  • March 22, 2013: FDA Public Workshop: Innovations in Breast Cancer Drug Development - Neoadjuvant Breast Cancer Workshop (FDA)
  • March 19th, 2013: FDA Webinar: Buyer Beware: The Risks and Dangers of Purchasing Drugs Online (FDA)

International

  • Is A Press Release Really An Ad? Ask Boehringer (Pharmalot)
  • Europe Transparency Initiatives May Aid Progress Toward Adaptive Licensing Systems (Euro Pharma Today)
  • Ukranian Health Ministry wants pharmaceutical companies to declare price of medicine during their registration (Kyiv Post)
  • Indian co seeks compulsory licence for cancer drug of Bristol Myers (PharmaBiz)
  • Australia reports jump in fake drug cases (Securing Industry)
  • Mozambique seeks cure for chronic shortage of medical supplies (The Guardian)
  • ECHA examines safety of cobalt salts used in pharma manufacturing (Pharmafile)
  • India's BDR Files Compulsory License For BMS' Sprycel; Next Up Ixempra And Herceptin? (PharmAsia News) ($)
  • Calls for collaborative innovation push at MHRA Annual Lecture (MHRA)
  • Mexican Senate Increases Penalties For Medicine Counterfeiters (Partnership for Safe Medicines)
  • Novo Nordisk "pleased" with obesity trial results (Reuters)
  • European Commission Approves New Pre-Treatment Options For QUTENZA™ (8% Capsaicin Patch) In Peripheral Neuropathic Pain (Medical News Today)

General Regulatory and Interesting Articles

  • Analysis: Antibiotics crisis prompts rethink on risks, rewards (Reuters)
  • Agencies warn of global TB "powder keg", funding gap (Reuters)
  • Tamiflu Resistance May be Rising (Med Page Today)
  • The Rare Disease Search Engine That Outperforms Google (MIT Technology Review)
  • Tailoring Biopharma Production to Demand (BCG)
  • What Designers of Next-Generation Surgical Clamps Can Learn from the Remora Fish (Med Tech Insider)
  • Swine flu cases resistant to Tamiflu are becoming more common, say scientists (The Guardian)
  • Developing Robust Potency Assays for Validation: A Case Study (PPDI)

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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