Regulatory Reconnaissance (12 April 2013)

Posted 12 April 2013 | By Alexander Gaffney, RAC 

Good morning and welcome to another edition of Regulatory Reconnaissance.

In the US, FDA finds widespread issues with inspected compounding pharmacies, a prominent Senator says new compounding legislation will be completed next month, the former head of FTC doesn't think they'll win outright in a lawsuit against the generic industry, an upcoming court case could dramatically affect the biotechnology industry, FDA releases a list of all 510(k) clearances for March 2013, the device industry calls for regulatory convergence in a US-EU trade deal, a former FDA regulatory official starts up a new regulatory science center, regulators are feeling pressure to release social media guidance, uninjured patients may now have standing to sue FDA, federal researchers claim a study on premature babies was ethical, DEA places cannibinoids and bath salts into Schedule I of the CSA, a bill to restrict regulations advances in the House of Representatives and FDA's Margaret Hamburg will testify before House legislators twice next week.

Abroad, France's ANSM releases a one-year report on defective PIP breast implants, India's pharmaceutical industry thinks a recent FDA guidance on SUPAC will boost global regulatory compliance, EMA reviews a new quidrivalent flu vaccine manufactured by Sanofi, CDSCO launches a new import webpage, EMA is out with highlights from its Pharmacovigilance committee, EMA issues a new guideline on good pharmacovigilance practices, an EU scientific committee looks at dental Amalgam, EMA rejects Abbvie copyright claims, NICE rejects Cell Therapeutics' blood cancer drug, and Health Canada touts a model regulatory process for natural health products.

Plus: Novartis allegedly duped into purchasing counterfeit anti-counterfeiting technologies.

Five in Focus

  • Sen. Lamar Alexander to Paper: Compounding Legislation to be Completed by Late May 2013 (Tennessean)
  • Biotech Industry at Stake in Human Gene Patent Decision (Bloomberg) (Scientific American)
  • Indian pharma expects US FDA's SUPAC Manufacturing Equipment Addendum to boost global regulatory compliance (PharmaBiz)
  • Former FDA ODE II Director Meyer Building New Regulatory Sciences Center at UVA (RPM Report) ($)
  • More Generic Suits Cite Brands Blocking Bioequivalency Studies (FDA News) ($)


  • FDA finds widespread safety issues at compounding pharmacies (Washington Post) (WSJ) (NYTimes)
  • Sen. Lamar Alexander to Paper: Compounding Legislation to be Completed by Late May 2013 (Tennessean)
  • Risky drug-compounding method rarely used, survey finds (Modern Healthcare)
  • Ex-FTC Head Predicts Partial Win On Pay-For-Delay (Law 360) ($)
  • Biotech Industry at Stake in Human Gene Patent Decision (Bloomberg) (Scientific American)
  • More Generic Suits Cite Brands Blocking Bioequivalency Studies (FDA News) ($)
  • FDA Launches Webpage to Help Consumers Check if Their Online Pharmacy is Legitimate or Not (FDA)
  • U.S. works with Inovio in prep for bioterrorism vaccinations (Fierce Biotech) (Reuters)
  • Dr. Reddy's Laboratories Ltd. (RDY)'s Withdraws Muscle Relaxant From the U.S. (BioSpace)
  • Otsuka's New Drug Application For Tolvaptan, The Investigational Compound For Autosomal Dominant Polycystic Kidney Disease (ADPKD), Acceped For Review By The Us Food And Drug Administration (FDA) (Otsuka)
  • BTG vein treatment on track for potential 2014 launch (Reuters)
  • Boston Therapeutics Wants IND Meeting (Drug Discovery and Development)
Medical Devices
  • Medtronic Initiates U.S. Trial to Evaluate the Use of Subcutaneous Peripheral Nerve Stimulation for Chronic Back Pain (Medtronic)
  • BD Announces FDA 510(k) Clearance of UltraSafe PLUS Passive Needle Guard (Infection Control Today)
  • Biolase's FDA win includes more than 80 indications for soft tissue laser (Mass Device)
  • Maquet lands FDA nod for Air-Band catheter device (Mass Device)
  • Elekta lands FDA win for next-generation linear accelerator (Mass Device)
  • Medtech calls for regulatory convergence In US-EU trade deal (Medical Design)
  • A Peek at Challenges From the Office of Combination Products (MDDI)
  • March 2013 510(k) Clearances (FDA)
  • Devicemakers Considering Combo Products Need to Know Drug GMPs (FDA News) ($)
  • PMA Petition for Natrelle Posted to FDA Docket (FDA)
  • Former FDA ODE II Director Meyer Building New Regulatory Sciences Center at UVA (RPM Report) ($)
  • Regulators Feeling 'Social' Pressure (WSJ)
  • Sound The Alarm: Uninjured Plaintiffs Now Have Standing (Law 360) ($)
  • For Doctors, Fewer Perks and Free Lunches (WSJ)
  • When Is Off-Label Use Not Off Label? (Drug and Device Law)
  • Federal Researcher Calls NIH Baby Study Ethical (WSJ) (Harvard Bill of Health)
  • Sen. Durbin, Blumenthal Shred Energy Drinks (Food Product Design)
  • FCC picks Quinn as new director of health care initiatives, will work with FDA (Mobi Health News)
  • Schedules of Controlled Substances: Temporary Placement of Three Synthetic Cannabinoids Into Schedule I (DEA) (The Hill)
  • Schedules of Controlled Substances: Placement of Methylone into Schedule I (DEA)
  • New technology speeding progress on bird flu vaccine (Reuters)
  • Extension of Public Comment Period for Request for Information on the FY 2013-2018 Strategic Plan for the Office of Disease Prevention (NIH)
  • Orphan Drug Prices Challenged in Europe - Will the U.S. Follow? (FDA Lawyers Blog)
Government and Budget
  • Tensions flare as lawmakers mark up regulation bill (The Hill)
  • House panel advances bill giving Congress veto power over regulations (The Hill)
  • Business groups push for regulatory transparency (The Hill)
  • NIH has big FY 14 spending plans, despite economic pressure (SCRIP Intelligence)
Upcoming Meetings and Events
  • 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)
  • 18 April 2013: A Financial Review of the Department of Health and Human Services and Its FY 2014 Budget (E&C)
  • 19 April 2013: Senate Appropriations Subcommittee on Agriculture and FDA to Hold Hearing, Hamburg Will Testify (Appropriations)
  • 26 April 2013: Senate Appropriations Committee to Markup FDA Bill (Appropriations)
  • Other Upcoming FDA Advisory Committee Meetings and Topics (Eye on FDA)


  • French Regulator ANSM Issues One-Year Status Report on Defective PIP Breast Implants (ANSM)
  • EMA Issues New Guideline on Good Pharmacovigilance Practices (GCP) (EMA)
  • Indian pharma expects US FDA's SUPAC Mfg Eqpt Addendum to boost global regulatory compliance (PharmaBiz)
  • Scientific Committee on Health and Environmental Risks (SCHER): Meeting of the Working Group on Dental Amalgam - Env. Effects (SCHER)
  • Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 April 2013 (EMA)
  • Drug patent row: Delhi High Court seeks Glenmark's response by May 22 (India Times)
  • Zombies, Free Trade And Access To Medicines (Pharmalot) (PharmaBiz)
  • EMA reviews new Sanofi flu vaccine (Pharma Times) (BioSpectrum)
  • CDSCO Launches New Import Page (CDSCO)
  • Transparency: EMA rejects Abbvie copyright claims, mulls InterMune patent ploy (SCRIP Intelligence)
  • Concept paper on the need for a reflection paper on quality aspects of medicines for older people (EMA)
  • Cell Therapeutics fails to gain NICE backing for blood cancer drug (PMLive) (The Pink Sheet) ($)
  • Aussie health regulators issue 3 warnings on Medtronic insulin pumps (Mass Device)
  • Patient groups directions 'not good for patients' - NICE (Pharma Times)
  • Essential Drug List Prices down An Average 26% in Beijing for 2013 (PharmAsia News) ($)
  • Update on TGA decision to cancel prescription pain-killers (TGA)
  • Health Canada Touts More Efficient Regulatory Process for Natural Health Products (Health Canada)
  • Novartis allegedly duped in anti-counterfeiting deal (Securing Industry)
  • Epidemiological update of 11 April: novel influenza A virus A(H7N9) in China (ECDC)

General Regulatory and Interesting Articles

  • Researchers create edible biosensors to measure core body temp, detect GI tract problems (Med City News)
  • Big brain projects highlight drug research gaps (Reuters)
  • Interactions between drugs can also be measured at lowest doses (
  • "Biologically active putty" under development could help bone fractures heal quicker (Med City News)

Regulatory Reconnaissance #44 - 12 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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