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Regulatory Focus: Week in Review (9-13 July)

Latest News | Posted: 13 July 2012

By Alexander Gaffney

Regulatory Focus is proud to bring you another edition of Week in Review—a recap of the global regulatory news space for the preceding week. We cover news and regulatory intelligence from around the globe and bring it to you in one organized location. If you read just one thing this week, make it Regulatory Focus’ Week in Review.

Top News Items

New EU Clinical Trials Regulations to Come As Early as Next Week
European Commissioner for Health and Consumers John Dalli plans to introduce new clinical trials legislation as early as 17 July, reports Reuters.

Obama Signs FDA User Fee Bill Into Law
US President Barack Obama signed the Food and Drug Administration Safety and Innovation Act (FDASIA) into law on 9 July 2012.

Clock Starts Ticking on Issuance of FDA's Social Media Guidance
Included in the Food and Drug Administration Safety and Innovation Act (FDASIA), recently signed into law by President Barack Obama, is a provision mandating that FDA issue social media guidance no later than 9 July 2014.

FDA Enacts New Class-wide REMS Policies for Opioids
The US Food and Drug Administration (FDA) announced the approval of a new class-wide Risk Evaluation and Mitigation Strategy (REMS) for the most potent opioid products on the market, saying in a statement that the new policies are meant to balance patient access and safety measures to improve the safe use of the products.

Regulatory Focus Features

[Editor’s Note: During the Month of July 2012, all Regulatory Focus Articles Are Accessible at No Charge]

• Voluntary Harmonization Process for Multinational Clinical Trials in the EU
• Perspective: Advancing Breakthrough Therapies for Patients
• Approval of Jakafi (ruxolitinib) Based on a Home-Grown, Patient-Reported Outcome Instrument: A Case Study
• Changes Coming to FDA Quality System Requirements for Prefilled Injection Devices
• Biosimilar Medicinal Products: Innovation in Regulatory Review and Approval
• Can Rodent Carcinogenicity Testing Be Eliminated?

US News

Medical Devices

• Changes Coming to Medical Device Pre-submission Meeting Program (Regulatory Focus)
• Companion Diagnostic Test, Drug Get Concurrent Approval from FDA (Regulatory Focus)
• US Regulators Reclassify Pacemaker Electrodes as Higher-Risk Devices (Regulatory Focus)
• US Regulators Move to Reclassify Medical Device as Class III (Regulatory Focus)
• FDA publishes final computer-assisted detection technology guidance (FierceHealthIT)
• Requirement for Premarket Approval for Shortwave Diathermy for All Other Uses; Effective Date  (FDA)
• CDRH Learn: Unique Device Identification (UDI) System (FDA)
• How Chinese country of origin rules ultimately hurt U.S. medical device manufacturing jobs (Med City News)

Pharmaceutical and Biologics

• FDA Enacts New Class-wide REMS Policies for Opioids (Regulatory Focus)
• FDA: Stop Manufacturing Unapproved Oxycodone Products (Regulatory Focus)
• FDA Wants Industry Input on New Drug Review Process (Regulatory Focus)
• FDA Releases Draft Guidance Changing Blood Donation Criteria (Regulatory Focus)
• Drug Reformulations Lead to Shifting Patterns of Abuse (Regulatory Focus)
• DEA to Increase Supply of ADHD, Opioid Ingredients in Light of Shortages (Regulatory Focus)
• As Death Penalty Opponents Target Drug Supply Regulations, States Move to New Methods (Regulatory Focus)
• F.D.A. Rejects Mandatory Training in Painkillers for Doctors (NYTimes)
• BIO and PhRMA insist on unique names for biosimilars (Biosimilar News)
• Renewal of Declaration Regarding Emergency Use of All Oral Formulations of Doxycycline Accompanied by Emergency Use Information (FDA)
• FDA approves first DNA test to help manage CMV infection in organ transplant patients (FDA)
• FDA Notification to Industry: Products using oils, glycerin, or protein that were derived from the Jatropha plant may have toxic effects
• Impact of Severe Weather Conditions on Biological Products (FDA)
• Merck stops osteoporosis trial early on positive results (PM Live) 

Other US News

• Clock Starts Ticking on Issuance of FDA's Social Media Guidance (Regulatory Focus)
• Massachusetts Loosens Ban on Industry Gifts (Regulatory Focus)
• 2011 Annual Report: Center for Veterinary Medicine (FDA)
• TMI from TIMI: Xarelto and the Trouble with Very Large Trials (RPM Report) 
• Patient Exclusion Analysis Coming From FDA; Changes In Trial Recruitment Could Follow (The Pink Sheet)
• DTC Held Hostage? FDA Pre-Review of TV Ads May Delay Rx Campaigns (RPM Report)
• Nursing Facility Assessments and Care Plans for Residents Receiving Atypical Antipsychotic Drugs (DHHS/OIG)
• REMS Assessments Could Measure Behavior, Not Just Knowledge, Industry Tells FDA (The Pink Sheet)

Legislative Update

• Obama Signs FDA User Fee Bill Into Law (Regulatory Focus)
• Proposed Legislation Would Require FDA to Develop Guidelines to Ensure Scientific Quality (Regulatory Focus)
• FDA Law Blog: FDASIA Enacted; HP&M Issues Detailed Summary and Analysis (FDA Law Blog)
• Law spurs regulators to heed patients’ priorities (Nature)

The Courts

• Lawsuit: FDA Tissue Donation Regulations 'Unconstitutional' (Regulatory Focus)
• Pharmaceutical Manufacturer Sues FDA Over Use of Enforcement Discretion (Regulatory Focus)
• Retailers sue Pfizer, charge generic Lipitor delay  (Pharm Pro)
• Insight: As lawsuits climb, J&J may have new hip trauma (Reuters)
• Hospira shortage can't be blamed for woman's blindness (Fierce Pharma Manufacturing)
• Woman Sues Pfizer For Alleged Injury In A Trial (Pharmalot)
• FTC Testimony Expresses Concern that Owners of "Standard-Essential" Patents May Obtain Injunctions Enabling Them to Hold Up Other Firms (FTC)
• U.S. Government: Mayo Decision Supports Prior Argument That Isolated Genomic DNA Is Not Patent Eligible (Patent Docs)

Compliance and Safety Issues

• FDA: Bausch & Lomb Marketed Product Using Rejected Claims for Years (Regulatory Focus)
• Untitled Letter to Acorda Therapeutics Highlights Recent FDA Review Trends (Regulatory Focus)
• Valeant, Lundbeck Warned for Leaving Warnings out of Promotional Video (Regulatory Focus)
• Pfizer Receives Untitled Letter for Presentation of Drug Risks (Regulatory Focus)
• Glaxo Tries to Shake Marketing Questions on Advair (WSJ)
• GlaxoSmithKline fraud case: Does crime pay? (Al Jazeera)
• Merck Hid Evidence Of Vioxx Harm: Study (Pharmalot)
• Safety concerns bring Ipsen haemophilia trial to halt  (PMLiVE)
• Centrum Dropping 'Breast Health' And 'Colon Health' Claims (NPR)
• Fierce's 2012 Top 10 FDA Red Flags (Fierce Pharma Manufacturing)
• FDA Safety Communication: Advanced Sterilization Products (ASP) Sterrad Cyclesure 24 Biological Indicators Revised Expiration Dates (FDA)
• FDA warns on Covidien's liquid embolic system following 9 patient deaths (Mass Device)
• Cardiac Diagnostic Tests Recalled (Med Page Today)
• Stryker Recalls Hip Implants (Med Page Today)
• Maquet Medical Systems USA FLOW-i Anesthesia System: Class 1 Recall - Device Field Correction (FDA)
• Alere Triage Diagnostic Tests (Multiple Tests): Class I Recall - Potential for Significantly Decreased Precision (FDA)
• Sedona Labs Issues A Voluntary Recall For iFlora Kids Multi-Probiotic And iFlora 4-Kids Powder Dietary Supplements Due To Possible Health Risk (FDA)
• Stryker Initiates Voluntary Product Recall of Modular-Neck Stems Action Specific to Rejuvenate and ABG II Modular-Neck Stems (FDA)
• Fullerton company's fat-melter an issue for FDA (The Orange County Register)
• FDA Enforcement Report - Week of July 11, 2012 (FDA)

Workshops & Meetings

• Meetings: Anti-Infective Drugs Advisory Committee (FDA)
• Meetings: Regulatory Science Considerations for Medical Countermeasure Radiation Biodosimetry Devices (FDA)
• Meetings: FDA, Xavier University Global Outsourcing Conference (FDA)

 

EU News

Regulation and Guidance

• European Regulators Issue 'Major Revision' to Guideline on Investigating Drug Interactions (Regulatory Focus)

EMA Information

• Report: New EU Clinical Trials Regulations to Come As Early as Next Week (Regulatory Focus)
• EMA, PIC/S to Harmonize Good Manufacturing Practices for Pharmaceuticals (Regulatory Focus)
• EMA to Applicants: Go Digital--and Don't Forget Croatia (Regulatory Focus)
• EU: New European Healthcare Advisory Panel Formed (Regulatory Focus)
• EMA investigates conflicts of interest involving officials and pharma (Fierce Biotech)
• Sanofi-aventis withdraws its marketing authorisation application for Mulsevo (semuloparin sodium) (EMA)
• New call for patient and healthcare-professional representatives on European Medicines Agency committees (EMA)
• Scientific recommendation on classification of advanced therapies (EMA)
• EMA announces next steps for the maintenance of information on medicines in accordance with mandatory Article 57(2) requirements  (EMA)

Other EU News

• UK: Consultation on New Medicines Reclassification Guide (Regulatory Focus)
• Germany: IQWiG Recommends Combination Rilpivirine for HIV (Regulatory Focus)
• MHRA Releases IVD Guidance for Notified Bodies (Regulatory Focus)
• UK regulators warn on counterfeit J&J surgical clips (Mass Device)
• European Parliament roundly rejects ACTA (Securing Pharma)
• EU Parliament deep-sixes counterfeiting law, drugs and all (Fierce Pharma Manufacturing)
• EC: Responses to the public consultation on the concept paper on the detailed rules for a unique identifier for medicinal product for human use  (EC)
• MHRA warns arthritis sufferers about buying unlicensed arthritis treatment (MHRA)
• Serge Bernasconi Appointed CEO of EDMA and Eucomed (Medtech Insider)

 

Global Regulatory News

• Australia: Why hasn't the TGA taken Stilnox off the market? (TGA)
• Brazil: Updates to Biologics Regulations Proposed (Regulatory Focus)
• Brazil: Anvisa Defends Newly-won Right to Deny Patents (Regulatory Focus)
• Canada's 2011 Adverse Event Data Shows Increasing Number of Reports (Regulatory Focus)
• Canada: Final guidance on Class III, IV device licensing from Health Canada (Mass Device)
• China: AEI - Chinese regulator must crack down on drug producers who cut corners
• UK: Grünenthal and Vifor fall foul of ABPI Code (PharmaTimes)
• Canada: Guidance on supporting evidence to be provided for new and amended licence applications for Class III and Class IV medical devices, not including In Vitro Diagnostic Devices (IVDDs) (Health Canada)
• ICH to Minimize Role of Industry in Harmonization Process (Regulatory Focus)
• ICH Releases New Interchangeability Standard for Pharmaceutical Powders (Regulatory Focus)
• India: India's Biosimilar Guidance to Come Into Effect in August (Regulatory Focus)
• Indian pharma urges govt over US user feesIndia: Dogged with corruption, drug regulation is in poor health and ineffective (The Economic Times)
• India: India losing out on clinical trial biz pie (Financial Express)
• ISPE Issues Guidance for Packaging, Labeling, and Warehousing Facilities (Biopharma International)
• IEC to Issue Amendment 1 to 60601-1, 3rd Edition Medical Electrical Equipment Standard (MDDI)
• Pakistan: Drug manufacturing suffers as Pakistan scandal heats up (Fierce Pharma Manufacturing)
• Singapore: HSA Alerts Public to Illegal and Adulterated Capsules That Have Caused Serious Adverse Reactions

Important Studies, Whitepapers and Research

• HIV Treatment as Prevention: Considerations in the Design, Conduct, and Analysis of Cluster Randomized Controlled Trials of Combination HIV Prevention (PLoS)
• Underreporting of cardiovascular events in the rofecoxib Alzheimer disease studies (American Heart Journal)
• RA Trial Results Not Skewed by Industry Dollars (Med Page Today)
• Study reveals overuse of drug-coated heart stents (The Boston Herald)
• Researchers develop secure protocol for linking data registries for HPV surveillance (EurekAlert)
• Vaccine and antibiotics stabilized so refrigeration is not needed (NIH)
• Study: Obamacare is a net loss for pharmas (MMM)
• Justice for Injured Research Subjects (NEJM)

Regulatory Reads

• Unnecessary’ trial procedures cost up to US$5 billion a year (Pharma Times)
• When Does An App Need FDA's Blessing? (NPR)
• Searching for a Regulatory "Tsunami" in Calm Seas (OMB Watch)
• The Real Promise of Mobile Health Apps (Scientific American)
• Unbalanced Retrospective Regulatory Review (Reg Blog)

Other News and Interesting Reads

• New Tool in Fight vs. Jewish Genetic Diseases: A Catalog (WSJ)
• U.S. Patients Get Access To More Cancer Drugs, But Pay For The Privilege (Forbes)
• Letting Big Pharma Review Its Own Drugs — What Could Go Wrong? (The Atlantic)
• Obama's Global Health Policy Undercuts Reform At Home (Huffington Post)
• The Global Drug Market Will Swell To $1.2 Trillion While Big Pharma Treads Water (Forbes)
• Some Doctors Cash In by Being Their Own Pharmacist