Regulatory Reconnaissance (25 February 2013)

Posted 25 February 2013 | By Alexander Gaffney, RAC 

Good morning and welcome to another edition of Regulatory Reconnaissance. Just four days until budget sequestration kicks in. The White House now says approval times for drugs and devices will likely suffer under such a scenario, which seems more and more likely by the day.

In the US, it's a good day to be a lawyer. J&J is under a new DOJ investigation, its DePuy subsidiary recalled a knee implant device, Takeda/Affymax recall Omontys over reports of anaphylaxis, Kentucky sues GSK, the pharmaceutical industry is upset about an Alabama preemption case, Stryker gets sued over their hip implants, and GNC and USPlabs get sued over a DMAA supplement's safety.

Abroad, India's government is still dragging its feet on reforms to the CDSCO, IFPMA is out with a report on why incremental innovation is important to global health, Swedish regulators have rules a press release is advertising, Australia's PM wants to boost clinical trials, and French regulators have issued warnings about two drugs, misoprostol and allopurinol.


Five in Focus:

  1. Feds probe J&J on recalled hip implant marketing (Modern Healthcare) (WSJ) (AP)
  2. Takeda, Affymax Recall All Lots of Anemia Drug as Advisory Committee Remarks Prove Prophetic (Regulatory Focus)
  3. Depuy is Recalling Nearly All of its LPS Diaphyseal Sleeve Devices (Unless Already in Use) Due to Potential Fracturing of the Taper Joint (FDA) (Reuters)
  4. Ranbaxy to resume generic Lipitor production for US (Reuters) (NYTimes)
  5. FDA panel recommends approval of NeuroPace's anti-epilepsy implant (Mass Device) (Medpage Today)
  • Primer: What you Need to Know About the Sequester (Bipartisan Policy Center) (Washington Post) (The Hill)
  • White House Report Says FDA Would Need to "Reduce Operational Support for Meeting Review Performance Goals" (White House) (Maryland, Page 4)
  • Alabama Supreme Court's Generic-Drugs Ruling Stirs Backlash (WSJ)
  • FDA Denies Reckitt Petition Over Generic Suboxone (Pharmalot) (Reuters) (The Guardian)
  • FDA rejects Dynavax's adult hepatitis B vaccine on safety concerns (Reuters)
  • Pediatric Advisory Committee Meeting to Discuss Actemra, Alimta, Creon, Gadavist, Hizentra, Inomaxx, Invega, Kedumin, Kytril, Lamictal XR, Menactra, Moxeza, Natroba, Nexium, Nexium IV, Uroxatral and Zenpep. Also, Codeine. (FDA)
  • FDA's Medical Imaging Drugs Advisory Committee and Oncological Drugs Advisory Committee to Assess Leukocyte Growth Factors (Neupogen, Neulasta, Leukine, and TBO-Filgrastim (FDA)
  • Do-It-Yourself Tests Enable Cancer Diagnosis in Bathroom (Bloomberg)
  • FDA OKs Wellaho mobile patient health monitoring system (Mass Device)
  • Ky. attorney general sues GlaxoSmithKline (AP)
  • Texas Company Accused of Marketing Unapproved Product Settles With States for $48 Million (The Baltimore Sun)
  • J&J's Toxicologist Says Metal From Recalled Hip Harmless (Bloomberg)
  • Hamburg Speech Touts Regulatory Science Approach (FDA)
  • Iowa Resident Brings Suit Against Stryker For Damages Caused By Recalled Hip Implant (Fierce Medical Devices)
  • US to Adopt Open Access Policy for all Federally Funded Research (White House) (Science Magazine)
  • Novartis MS drug wins FDA clearance for trial as ALS treatment (Boston Herald)
  • Kabco Pharmaceuticals, FDA Heading Toward Consent Agreement (Natural Products Insider)
  • Soldier's Parents File Wrongful Death Lawsuit against USPlabs, GNC Over DMAA (Natural Products Insider)
  • Patients oppose OTC-to-Rx switches for pseudoephedrine drugs, survey finds (Drug Store News)
  • Obama administration joins lawsuit against Lance Armstrong (The Hill) (Regulatory Focus)
  • Should FDA Have Used Surrogate Endpoints to Approve the Anti-TB Drug Sirturo? (JAMA)
  • Clueless About an the Upcoming Supreme Court Hearing on AMP vs. Myriad? Check out this Comprehensive Primer (SCOTUSblog)
  • FDA's Friday Approval of Kadcyla is Just The Latest in a Huge Number of Oncology Drugs Approval by the Agency (CenterWatch)
  • Hamburg Op-Ed: Weaving New Threads in FDA's Global Safety Net (FDA Voice)
  • FDA Weekly Enforcement Report for 20 February 2013 (FDA)
  • Opinion: Congress, FDA Should Look To Existing Technology To Make Pharmacy Compounding Safer (Pharmaceutical Online)
  • Social Media Site Could Help FDA Track Adverse Events (The Pink Sheet) ($)
  • Pharma Social Media Sites Struggle For Audience Under Shadow Of Potential FDA Action (The Pink Sheet) ($)
  • mHealth Regulatory Coalition out With Three New Issues Briefs on Mobile Health Technologies (1) (2) (3)
  • Meeting Materials Posted for FDA Workshop on Minimal Residual Disease as a Surrogate Endpoint in CLL (FDA)


  • EMA recommends approval for Sanofi vaccine Hexyon (Pharma Times)
  • India's Government Still Hasn't Acted on Report Faulting CDSCO for Drug Approval Lapses (PharmaBiz)
  • French Regulators Warn About use of Cytotec (misoprostol) and Allopurinol (xanthine oxidase inhibitor) (ANSM) (ANSM) (ANSM)
  • IFPMA highlights benefits of incremental innovation for global health (IFPMA) (Report)
  • Meeting highlights from the CHMP - 18-21 February 2013 (EMA)
  • Cost Increases Likely for API Distributors in Europe Under New GDP Proposals (In-Pharma Technologist)
  • Swedish regulator rules Boehringer press release is advertising (PM Live)
  • Argentina extends traceability programme for medicines (Securing Industry)
  • Australian PM Comes out in Support of Investment in Clinical Trials (Australian Dept. of Industry)
  • NHS Sale of personal gene data condemned as 'unethical and dangerous,' but could it be a boon to regulatory professionals? (The Guardian)
  • India: 436 lives lost during clinical trials of drugs in 2012 (DNA India)
  • India accounts for 20% of generics produced across globe: Minister (PharmaBiz)
  • Patients' and Consumers' Working Party (PCWP) and Healthcare Professionals' Working Group (HCPWG) joint meeting (EMA)
  • Healthcare Professionals' Organisations Working Group (HCP WG) (EMA)

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.

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