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

Regulatory Reconnaissance (22 March 2013)

Posted 22 March 2013 | By Alexander Gaffney, RAC 

Good morning and welcome to another edition of Regulatory Reconnaissance. Good news for regulators: Congress appears poised to avoid a government shutdown later this month, and have passed a continuing resolution that would fund FDA and give it access to more user fee funding as well.

In the US, FDA advisors recommend approval of Titan Pharmaceuticals's opioid dependence drug, a Democratic lawmaker wants to tighten the regulation of supplements, Janssen wants a $327 million off-label marketing verdict overturned, new legislation looks to tighten scheduling of opioid products, the Supreme Court meets Monday on the legality of pay-for-delay settlements, Virginia signs the first biosimilar drug substitution law in the nation, animal drug user fee bills clear a Senate committee, a three-day hearing on the regulation of mobile medical apps wraps up, and a US-based clinical research organization once used by many large companies declares bankruptcy.

Abroad, India has a plan to meet tough new API regulations in the EU, EU legislators press for clinical data disclosure, Australia says new OTC regulations are coming on 15 April 2013, new Indian drug pricing policies are announced, China's SFDA revokes marketing approval for Buflomedil APIs and drugs, and UK legislators are concerned that the NHS is rationing treatments.

Plus: Could a new and lethal strain of meningitis be the next big worry for public health officials?

Five in Focus:

  1. FDA advisers recommend approval of Titan Pharma's opioid dependence drug (Reuters) (Med Page Today) (BioCentury)
  2. New Legislation Would Schedule Any Substance Containing Hydrocodone in Schedule II; Leaves Hydrocodone Combination Product Storage Requirements for Non-Practitioners Consistent with Schedule III (FDA Law Blog) (NCPA Net) (LATimes) (Kirk) (Markey) (The Hill)
  3. Supreme Court to decide Monday on deals to delay cheaper drugs (Reuters) (Patent Baristas) (SCOTUS Blog)
  4. Committee Passes Animal Drug User Fee Agreements, Moves to Full Senate (Senate)
  5. India has plan to meet Europe's new API regs (Fierce Pharma Manufacturing)

US

Pharmaceuticals/Biotechnology
  • FDA advisers recommend approval of Titan Pharma's opioid dependence drug (Reuters) (Med Page Today) (BioCentury)
  • FDA approves Dotarem, a new MRI agent (FDA) Editor's Note: From Late Wednesday
  • A Battle In Maine Over Importing Drugs From Canada (Pharmalot)
  • Dem reaches out for support on regulation on dietary supplements (The Hill)
  • Teva's Cephalon Accused Of Fraud By Whisteblower (Pharmalot)
  • Janssen/J&J: No one in SC was harmed in $327M case, Overturn Verdict (Bloomberg)
  • Teva doesn't want its drugs used to kill people (Philly Pharma) (Fierce Pharma Manufacturing)
  • New Legislation Would Schedule Any Substance Containing Hydrocodone in Schedule II; Leaves Hydrocodone Combination Product Storage Requirements for Non-Practitioners Consistent with Schedule III (FDA Law Blog) (NCPA Net) (LATimes) (Kirk) (Markey) (The Hill)
  • Supreme Court to decide Monday on deals to delay cheaper drugs (Reuters) (Patent Baristas) (SCOTUS Blog)
  • Sanofi MS Drug Lemtrada Drug Effective In One-year Extended Late-stage Trail (RTT) (Pharma Times) (PMLive) (Fierce Biotech) (Bloomberg)
  • Bayer opposes efforts to consolidate Mirena IUD lawsuits (Thomson Reuters)
  • J&J's answer to Botox may escalate war on wrinkles (Reuters)
  • FDA Seeks Sources to run its Prescription Drug Labeling Improvement and Enhancement Initiative (FDA)
  • Incyte says Jakafi patient developed brain virus (PMLive)
  • CBER Issues Notices of Intent to Revoke Allergenic Extracts to Six Biologics Companies (1) (2) (3) (4) (5) (6), Approves One (1)
  • Corporate Integrity Agreement Between DHHS, Par Pharmaceuticals Posted (OIG)
  • Governor McDonnell Signs First in Nation Biosimilars Bill on Substitutability (Reuters) (GPhA)
  • PhRMA Pans ProPublica's Dollars for Doc Database (PhRMA)
  • Executive perspectives: John Castellani (PharmaPhorum)
  • FDA Updates 8 Medication Guides (FDA)
  • Titan Pharma: FDA Panel Live Blog (The Street)
  • $3.6 Million Of Fake Drugs Seized In South Carolina Warehouse (Safe Medicines)
  • Teva touts fresh PhIII evidence of oral MS drug's potential (Fierce Biotech)
  • Blumenthal Sends Letter To FDA Asking Why Agency Failed To Regulate Compounding Pharmacy That Manufactured Contaminated Drugs Found At Connecticut Hospital (Congress)
  • FDA Finds Hidden Ingredients in Three Products (FDA)(FDA) (FDA)
  • Antibiotics not worth risk in most chest colds: study (Reuters)
  • Students' petition calls on FDA to change ban on gay blood donors (CBS News)
  • AstraZeneca CEO says exploring biosimilars market (Reuters)
  • National Academies of Sciences hosting a workshop on revisions to the human-subjects regulations (the "Common Rule") (Harvard Bill of Health)
  • Fen-Phen Class Action Lawyer Disbarred Over Fraud Related to Diet Drug Case (Reuters)
  • Piramal Alzheimer's detector gets accepted for review by FDA, EMA (BioSpectrum)
Veterinary Pharmaceuticals
  • Committee Passes Animal Drug User Fee Agreements, Moves to Full Senate (Senate)
  • CBO Scores ADUFA/AGDUFA, Says it Will Save Government Money Over Next Five Years (CBO)
  • Implementation of the Updated American Veterinary Medical Association Guidelines for the Euthanasia of Animals: 2013 Edition (NIH)
  • New Animal Drugs: Sponsor Changes (FDA)
Medical Devices
  • Ethicon lands FDA nod for cordless Enseal G2 tissue sealer (Mass Device)
  • St. Jude claims 'landmark study' quells concerns over heart plug benefits (Fierce Medical Devices)
  • J&J metal hip problems keep erupting in the trenches (Fierce Medical Devices)
  • Five things we learned from the FDA's medical app testimony (Mobi Health News)
  • Intuitive Robosurgery Training Seen Lacking in Lawsuits (Bloomberg)
  • Platinum china trial demonstrates positive outcomes for the Boston Scientific Promus Element Stent (Boston Scientific)
  • How AstraZeneca Will Use A Diagnostic To Market Its Blood Thinner (Forbes)
  • Op-Ed: FDA regulation is the way to go for apps that are used to diagnose (Med City News)
Assorted
  • US-Based CRO Declares Bankruptcy, Cancels Ongoing Studies (Outsourcing Pharma) (Fierce Biotech)
  • Obamacare Has Helped Seniors Save Over $6 Billion On Their Prescription Drugs (Think Progress)
  • Toward a New and Improved Regulatory Apparatus: Could a new review agency improve federal regulation? (CATO)
  • Argument recap: Justices dubious of limits on attorney's fees in vaccine cases (SCOTUS Blog)
  • Alexander Praises Committee Passage of Boxer-Coburn Bill to Allow Research on Organ Transplants Between HIV-positive Individuals (Senate)
Government and Budget
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 25, 2013: FDA Webinar on Draft Guidance for Industry on Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products (FDA)

International

  • EU CRO Group Seeks to Widen Act on Post-Authorisation Efficacy Studies (Outsourcing Pharma)
  • India has plan to meet Europe's new API regs (Fierce Pharma Manufacturing)
  • EU politicos press for April regulation on clinical data disclosure (SCRIP Intelligence) ($)
  • Australian Regulators: New OTC Regulations Coming on 15 April 2013 (TGA)
  • Annual workshop on the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA)
  • Russia Officials Worry About Dependence On West For Drugs, Devices (PharmAsia News) ($)
  • New Indian drug policy to allow change in price cap before five year period (Economic Times)
  • SFDA Revokes Sales Permission For Buflomedil APIs And Drugs (PharmAsia News) ($)
  • MPs "concerned at NHS rationing of treatments" (Pharma Times)

General Regulatory and Interesting Articles

  • City Health Officials Warn Some Men on Lethal Strain of Meningitis (NYTimes)
  • Analytics firm wants to help pharma improve the odds on "go/no go" decision with new drugs (Med City News)

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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