Regulatory Reconnaissance (10 April 2013)

Posted 10 April 2013 | By Alexander Gaffney, RAC 

Good morning and welcome to another edition of Regulatory Reconnaissance. FDA's proposed FY2014 budget will be released later today. Check in with Regulatory Focus later for the details.

In the US, Ed Silverman interviews FDA's Janet Woodcock and Howard Sklamberg on the compounding crisis, Merck allegedly knew about Fosamax's bone risks back in 1990, a lawsuit against Impax Labs says it misled investors about manufacturing issues, Eli Lilly settles a wrongful death lawsuit, Smith Medical issues a class I recall, another smartphone app gets cleared by FDA, an artificial pancreas seems within reach, FDA may soon have to expedite FOIA requests, SCOTUS prepares to hear an argument on whether genes can be patented, industry comments on a new electronic source documentation guidance, and new warning letters get posted.

Abroad, CFDA orders quality-control monitoring of flu detection devices, Medtronic and TGA issue a warning about its Paradigm insulin pump, EMA recruits for new high-level positions, Medicines Australia says the industry puts profits over lives, and the UK turns to GSK's Andrew Witty for help.

Five in Focus

  1. FDA Acknowledges: We Could Have Done More To Pursue Compounders (Pharmalot)
  2. For Diabetics, a Longtime Goal Is Within Reach-An Implantable Pancreas (WSJ) (Fierce Medical Devices)
  3. D.C. Circuit Decision May Force FDA and Other Agencies to Expedite Responses to FOIA Requests (FDA Law Blog)
  4. Argument preview: The right to study genes (SCOTUS Blog)
  5. CFDA Orders Quality-Control Monitoring Of Devices Used In H7N9 Flu War (PharmAsia News) ($)


  • FDA Acknowledges: We Could Have Done More To Pursue Compounders (Pharmalot)
  • Plan B Ruling Curbs FDA's Power To Restrict Drug Access (Law 360) ($)
  • An Erosion of Power: The New Paradigm of FDA Drug Enforcement Actions (Bloomberg BNA)
  • Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations; Availability (FDA)
  • Merck Knew of Fosamax Bone Risk in '90, Lawyer Tells Jury (Bloomberg)
  • Impax Misled Investors About Manufacturing Issues, Suit Says (Law 360) ($)
  • Teva introduces generic painkiller (DSN)
  • Lundbeck touts promising head-to-head data on depression drug Brintellix (Fierce Biotech)
  • Getting Across the Phase III Finish Line  (Cancer Discovery)
  • EyeGate announces positive Phase 3 data with anterior uveitis treatment (Boston Business Journal)
  • Eli Lilly and Co. settles wrongful death lawsuit (Indy Star)
  • Roche's immune therapy drug seems to work against several types of cancer (Reuters)
  • EyeGate's EGP-437 meets Phase III endpoint (BioCentury)
  • Rx Response Planning Tweaks After Successful Efforts In Super Storm Sandy (The Pink Sheet Daily) ($)
  • Indiana Biosimilars Bill Inches Forward (Scout)
  • FDA Approves Sun Pharma's Generic Risperdal (ANDA #078464) (FDA)
  • Pfizer's Odour-Related Recall Creates Stink Among Drug Pack Tech Firms (Outsourcing Pharma)
  • Project FDA's Paul Howard Argues Long Drug Trials are Harming Patent-Holders at the Expense of Generics (Washington Times)
  • US races to make vaccine against new bird flu - just in case (NBC)
Medical Devices
  • For Diabetics, a Longtime Goal Is Within Reach-An Implantable Pancreas (WSJ) (Fierce Medical Devices)
  • BCI Remote Alarm Cables By Smith's Medical ASD, Inc.: Class 1 Recall - Cables Are Not Transferring Alarms (FDA)
  • NeuroBlate MRI-Guided Neurosurgical Laser Ablation System Receives FDA Approval (MedGadget)
  • ResolutionMD Android App Cleared by FDA for Diagnostic Imaging (MedGadget)
  • Delcath slips on FDA delay for drug/device Melblez Kit  (SCRIP Intelligence)
  • Pediatric Device Consortia Grant Program (FDA) (5 April)
  • Food and Drug Administration/National Institutes of Health/National Science Foundation Public Workshop on Computer Methods for Medical Devices (FDA) (5 April)
  • D.C. Circuit Decision May Force FDA and Other Agencies to Expedite Responses to FOIA Requests (FDA Law Blog)
  • Argument preview: The right to study genes (SCOTUS Blog)
  • More Med Schools Pass The Conflict-Of-Interest Test (Pharmalot)
  • Industry Comments on FDA Draft Guidance on Electronic Source Documentation in Clinical Investigations (FDA Docket)
  • New protocol design approaches will improve clinical trial performance and efficiency (CTTI)
  • FDA: Partnerships to Accelerate Medical Product Development (Policy and Medicine)
  • The Most Surprising FDA Decisions of 2013 (Motley Fool)
  • MES in the Life Sciences: An Interview with NNE Pharmaplan's Gilad Langer (Manufacturing Geek)
  • Medicare and State Health Care Programs: Fraud and Abuse; Electronic Health Records Safe Harbor Under the Anti-Kickback Statute (OIG)
  • Thoughts on regulatory constraints of business models (Lexology)
  • Lilly Thieves Claim Security Report Not Used (Drug Discovery and Development)
Government and Budget
  • Medical device tax repeal bill gains enough co-sponsors to pass House (Mass Device)
  • CMS Nominee Tavenner Gains Confirmation Momentum With Bipartisan Support At Senate Hearing (The Pink Sheet Daily) ($)
  • Obama budget director nominee grilled on regulatory agenda (The Hill)
  • Unions, watchdogs press Obama pick to end secrecy on regulations (The Hill)
  • Cass Sunstein on what law professors don't get about government (Fierce Government)
  • Cass Sunstein: "Simpler: The Future of Government" (NPR)
  • Cass Sunstein on making government simpler, not smaller (NPR)
  • Reminder: President's FY2014 Budget Due TODAY
Warning Letters
  • (Compounding) 483 Sent to Pentec Health, a Compunder, for Improper Sterility Assurance Procedures (FDA)
  • (Medical Device) THD SpA for CAPA, MDR, Design Verification, Process Validation (FDA)
  • (Medical Device) Eiken Chemical Co. for Adulteration, PMA, QSR (FDA)
  • (Medical Device) Safecross First Aid Ltd for Misbranding, MDR, QSR (FDA)
  • (Medical Device) Mega Sun Inc. for QSR (FDA)
  • (Dietary Supplement) Finemost Co. for Adulteration, CGMP, MMR, BPR, Misbranding (FDA)
  • (Dietary Supplement) Glutathione Corp. for CGMP, MMR, Unapproved New Drug, Misbranding, Sanitary Conditions (FDA)
  • (Dietary Supplement) Primarch Manufacturing Inc. for CGMP, MMR, BPR (FDA)
  • (Finished Pharmaceutical) Peking Medicine Manufactory for CGMP, Unapproved New Drug, Misbranded OTC Drug (FDA)
  • (Finished Pharmaceutical) Physicians Total Care for CGMP, Unapproved New Drugs (FDA)
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: Congressional Hearing: Reauthorization of Animal Drug User Fees: ADUFA and AGDUFA (E&C) (FDA Testimony)
  • 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) (Meeting Materials)
  • 17 April 2013: Cellular, Tissue and Gene Therapies Advisory Committee Meeting (FDA)
  • Other Upcoming FDA Advisory Committee Meetings and Topics (Eye on FDA)


  • CFDA Orders Quality-Control Monitoring Of Devices Used In H7N9 Flu War (PharmAsia News) ($)
  • Australia's TGA Issues Warning on Medtronic Paradigm Insulin Pump (TGA)
  • Alcon, TGA Issue Alert Over AcrySof Cachet Phakic Lenses (TGA)
  • China Drugmaker Access May Require Profit Cut, Chen Says (Bloomberg)
  • China drugmaker pulls flu treatment tainted with toxic herbs (Fierce Pharma Manufacturing)
  • EMA Doing Some Recruiting for IT and Business People (EC)
  • Protestors warn of meds access through EC-India trade deal (Pharma Times)
  • ASEAN Agreement On Pharma Manufacturing Standards Clears Hurdle For Closer Integration (PharmAsia News) ($)
  • Australian Group: Drug companies 'put profits over lives' (SMH)
  • UK Government asks Witty for help on universities (Pharma Times)
  • Five Japanese Drug Makers Form PPP To Accelerate Development Of Drugs, Vaccines For Infectious Diseases (Kaiser)
  • Preclinical CRO Pushes into India to Reduce Human Bioequivalence Studies (Outsourcing Pharma)

General Regulatory and Interesting Articles

  • Rare disease survey: Physician-patient networks could cut down diagnosis time (infographic) (Med City News)
  • Alarm Fatigue Is Putting Patients' Lives At Risk (Medical News Today)
  • Software debugging method touted for boosting safety of surgical robots (Fierce Health IT)
  • Previously snubbed, pancreatic cancer gaining R&D, funding momentum (SCRIP Intelligence)

Regulatory Reconnaissance #42 - 10 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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