Regulatory Reconnaissance (8 April 2013)

Posted 08 April 2013 | By Alexander Gaffney, RAC 

Good morning and welcome to another edition of Regulatory Reconnaissance.

In the US, former FDA official Susan Wood hopes that the Plan B "battle" is over, the AP identifies a number of challenges for the Obama administration if they choose to appeal the Plan B case, Senate minority leader Mitch McConnell presses FDA to act on prescription drug abuse, some think DEA is weighing down FDA's regulatory improvements, J&J initiates another major recall, Merck starts a new Fosamax trial, FDA's attempts to study bioequivalence issues in bupropion is behind schedule, Bayer gets priority review for its experimental hypertension drug Riociguat, GDUFA is off to a quick start, a malfunctioning HeartWare device is claimed to have led to a death, a regulatory science initiative starts to set its priorities, St. Jude faces lawsuits over its Riata heart wires, FDA shuts down a dietary supplement manufacturer, IOM plans to develop a clinical trial data sharing study, USDA's national organic program issues draft guidance on definition of natural vs. synthetic ingredients, NIH funds new studies on drug-herb interaction, and Obama's FY2014 budget is due on Wednesday.

Abroad, India's top court lets generic Januvia launch despite Merck's protests, India extends the deadline for pharma barcodes, depression drug trials are stalled in the UK because the substance is illegal, a UK company initiates a recall over a discolored and moldy drug, France's ANSM warns consumers about Vertex's Incivik, the number of Australian clinical trials continues to fall, an orphan drug strategy begins to backfire in an austere EU, the World Medical Association finishes work on a draft of the Helsinki Declaration, Australia plans to compensate organ donors, Apotex is reportedly recalling its birth control pill Alysena over too many placebo pills, and China's FDA clears Peramivir production to treat a troubling new flu strain.

Plus: How prevalent is dual enrollment in clinical trials, could cancer drugs be re-worked as biodefense products, and why did a pharmaceutical executive get caught with thousands of dollars in gold in his socks?

Five in Focus

  1. DEA Delays in Scheduling Are Offsetting FDA's Improved Decision Making (RPM Report) ($)
  2. Diabetes: FDA puts highest-risk status on J&J's Animas insulin pump recall (Pharmalot) (Mass Device) (Fierce Medical Devices) (FDA) (FDA) (Med Page Today)
  3. Medical Device Innovation Consortium Sets Priorities To Advance Reg Science (The Gray Sheet) ($)
  4. IOM Plans to Develop Clinical Trial Data Sharing Study: Industry Comes Out In Support (Pharma Manufacturing) (IOM) (IOM) (BioCentury)
  5. India's top court rebuffs Merck, lets generic Januvia roll out (Fierce Pharma) (Economic Times) (Pharma Times)


  • DEA Delays in Scheduling Are Offsetting FDA's Improved Decision Making (RPM Report) ($)
  • Is the Plan B battle over? Former FDA official Susan Wood hopes so (Washington Post)
  • Risk for Obama in pursuing morning-after pill case (Boston Herald)
  • Sen Minority Leader Mitch McConnell Contacts FDA Regarding Prescription Drug Abuse and Efforts to Ensure Safety of Generic Pain Pills (McConnell) (Letter to FDA)
  • Merck Starts Fresh Trial on Fosamax Broken-Leg Claims (Bloomberg)
  • Mylan rains on Valeant parade with Zovirax generic (Fierce Pharma) (Reuters)
  • US FDA Grants Priority Review to Bayer's Riociguat for the Treatment of two Life-Threatening Pulmonary Hypertension Indications (Bayer)
  • Generic Bupropion XL Reevaluation Running Behind Schedule (The Pink Sheet) ($)
  • Sarepta Therapeutics' Duchenne Therapy Issues New Data on Eterplirsen (The Street) (Fierce Biotech)
  • Biosimilars: Does Low BsUFA Fee Revenue Suggest Sponsor Interest Has Stalled? (The Pink Sheet) ($)
  • PDUFA Communications Hurt By Sequestration As Late-Stage Meetings Begin (The Pink Sheet) ($)
  • FDA Could Shift Assessment Of Drug-Induced Liver Injury In Clinical Trials (The Pink Sheet) ($)
  • GDUFA: FDA Sees High Fee Collection Rate After First Six Months (The Pink Sheet) ($)
  • Vertex, Bristol-Myers mix pills for Phase II study in hepatitis C (Fierce Biotech)
  • West-Ward Pharmaceuticals to discontinue Granistetron HCl Injection for Business Reasons (FDA)
  • Drug Shortages: Despite Gains, Many Drugs are Still in Short Supply (Policy and Medicine)
  • Federal Court Orders FDA to Approve OTC Emergency Contraception Without Restrictions, Describes Intervention by Secretary Sebelius as "Unprecedented" and "Politically Motivated" (FDA Law Blog)
  • Biogen exec explains $55K annual cost of new drug (Triangle Business News)
  • InVivo gets two FDA approval notes (Boston Business Journal)
  • Annual Blood Product Deviation (BPD) Report Summary for Fiscal Year 2012 (FDA) (FDA)
  • New PREA Information Post for Janssen's Darunavir (FDA)
  • BIVIGAM Recalled Over Presence of Visible Particles in Sterile IV (FDA)
  • Manufacturing Consent: Pharma Lobbying Letter to Congress Lists Opponents as Supporters (Forbes)
  • New Jersey introduces legislation to create a prescription drug donation repository program (Scout)
  • Texas schedules hearing on substitution of opioid analgesics (Scout)
  • California schedules hearing on prescription drug labeling (Scout)
  • Oregon schedules hearing on restricting substitution of biosimilar products (Scout)
  • The Board of Pharmacy Must Respond To Ideas For Making EPCIS Work (RxTrace)
Medical Devices
  • FDA Shuts Down Dietary Supplement Manufacturer Kabco (Natural Products Insider)
  • IOM Plans to Develop Clinical Trial Data Sharing Study: Industry Comes Out In Support (Pharma Manufacturing) (IOM) (IOM) (BioCentury)
  • Are Your "Natural" Food and Supplement Ingredients Really Natural? The National Organic Program Issues Draft Guidance Concerning Definition of Natural vs. Synthetic (FDA Law Blog)
  • FSMA guidance document serves as reminder to make sure facilities are registered (Nutra Ingredients USA)
  • Psychoactive Drugs Prescribed to Soldiers Increases 682% from 2005 to 2011 (NYTimes)
  • NIH funds drug-herb interaction research at University of Illinois at Chicago College of Pharmacy (DSN)
  • DHS Efforts to Assess Chemical Security Risk and Gather Feedback on Facility Outreach Can Be Strengthened (GAO)
  • Mark Senak's Weekly Roundup of FDA News (Eye on FDA)
Government and Budget
  • Obama budget plan "will cut payments to pharma" (Pharma Times)
  • White House fights Catholic Church subpoena on birth control (Med City News) (Reuters)
  • Sen. Harkin's Departure Like Losing Yankees' Derek Jeter to the Supplement Industry (Natural Products Insider)
  • US Capitol Capsule: Cell-based, recombinant shots new plan of attack against H7N9 (SCRIP Intelligence)
  • Reminder: President's FY2014 Budget Due on 10 April 2013
Meetings and Events This Week
  • 8 April 2013: Ophthalmic Devices Panel of the Medical Devices Advisory Committee Meeting Announcement (FDA) (Meeting Materials)
  • 9 April 2013: Reauthorization of Animal Drug User Fees: ADUFA and AGDUFA (E&C Committee)
  • 10 April 2013: Public Workshop: Application of Advances in Nucleic Acid and Protein Based Detection (FDA)
  • 11 April 2013: Device Good Manufacturing Practice Advisory Committee Meeting Announcement (FDA)
  • 17 April 2013: Cellular, Tissue and Gene Therapies Advisory Committee Meeting (FDA)
  • Other Upcoming FDA Advisory Committee Meetings and Topics (Eye on FDA)


  • India's top court rebuffs Merck, lets generic Januvia roll out (Fierce Pharma) (Economic Times) (Pharma Times)
  • India's deadline for pharma barcodes on primary level package extended (Economic Times)
  • NYTimes Calls India's Novartis Decision a "Quirk," Reflects on Nuances of the Case (NYTimes)
  • Catellani: India & The 'Latest In A Troubling Pattern Of Decisions' (Pharmalot)
  • First magic mushroom trial for depression stalled in UK because psilocybin still illegal (Reuters) (The Independent)
  • Clinical trials directive: The Parliament's political dilemma (EurActiv)
  • UK Company Recalls Paracetamol Over Mold Causing Discoloration (MHRA)
  • Pharma companies partner with Japanese government to develop innovative medicines for infectious diseases (PMLive)
  • Orphan Drug Prices Under Siege in Austerity-Minded Europe (Bloomberg)
  • France's ANSM Issues Warning About Vertex's Incivik (telaprevir) (ANSM)
  • Number of new clinical trials in Australia continues to fall (Medicines Australia)
  • Public to be Consulted Over Changes to the World Medical Association's Declaration OF Helsinki (WMA)
  • AllTrials campaign announces next steps (Pharma Times)
  • Australia to Compensate Organ Donors (Marginal Revolution)
  • AIDCOC urges Indian pharma cos to charge reasonable prices on all generic drugs (PharmaBiz)
  • China FDA Clears Peramivir Production To Treat Spreading H7N9 Flu (PharmAsia News) ($)
  • Health Canada recalls Apotex's birth control pill Alysena (Global News CA)
  • Australian Pharma Industry "Astonished" By Call To Cut Patent-Term Extensions (PharmAsia News) ($)
  • Aussie Researchers Say 15 Expensive Drugs Average 50 Patents Each (PharmAsia News) ($)
  • China: 2012 Annual Report for National Medical Device Adverse Event Monitoring released (CFDA)
  • China obtains ISO/TC150/SC7 voting rights (CFDA)

General Regulatory and Interesting Articles

  • How prevalent is dual enrollment in clinical trials? Opinion split (Outsourcing Pharma)
  • What are Regulation's Effects on Employment? (RegBlog)
  • Cancer drugs to stop bioweapons (Fox News)
  • Diabetes trials worldwide are not addressing key issues in affected populations (EurekAlert)
  • Pharmaceutical executive caught at airport with Rs 3 lakh gold bar in socks (Times of India)

Regulatory Reconnaissance #40 - 8 April 2013

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 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.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @AlecGaffney or send him an email at

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