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

Latest News | Posted: 13 April 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. If you read just one thing this week, make it Regulatory Focus’ Week in Review.

Previous Week in Reviews: [2-6 April] [26-30 March]

Top News Items

User Fees Could Be In Peril in Partisan Congress, Says Report
A Bloomberg Government study contends a partisan Congress seeking to make changes to the US Food and Drug Administration (FDA) and the user fee legislation that funds it could put the entire package of user fee legislation in jeopardy. More »

Hamburg Calls for New Authority, Strengthened Anti-Counterfeit Laws
US Food and Drug Administration (FDA) Commissioner Margaret Hamburg said in a statement she believes existing pharmaceutical anti-counterfeiting laws are grossly inadequate to deter illicit activity, saying counterfeiters deserve "more severe consequences."  More »

Report: India Boosting Ability to Regulate Clinical Trials
India's regulatory authorities are boosting their ability to enforce regulatory guidelines after years of heightened requirements, reports Outsourcing Pharma. More »

EMA Releases New Biosimilar Q&A Guidance
The European Medicines Agency (EMA) has published a new guidance document that brings together in a single place a number of regulatory and procedural questions on biosimilars. More »

Regulatory Focus Features

• Perspective: A Modern Progressive Approval System for Rare Diseases (Regulatory Focus)
• Regulatory Intelligence Tools: Drugs – 2012 Update (Regulatory Focus)
• US Biosimilar Guidelines: Summary and Insights (Regulatory Focus)
• Mastering the eCTD Format Critical for Regulatory Submissions Pros (Regulatory Focus)
• A Conversation With From Alzheimer’s to Zebrafish Author Max Sherman (Regulatory Focus)

US News

Regulation and Guidance

• ICH Safety Reporting Standard Advanced by FDA (Regulatory Focus)
• Post-Market Safety Updates Replaced By “Periodic Benefit-Risk Evaluation Reports” (The Pink Sheet)
• FDA Publishes New Guidance on PET Drug GMPs (Regulatory Focus)
• As Final Guidance is Released, Deadline for PET Drug Compliance Draws Near (Regulatory Focus)
• FTC Announces Schedule for Reviewing Regulations (FTC)
• FDA Releases New Guidance Banning Many Uses of Antibiotics in Animals (Regulatory Focus)
• Medicare Program; Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs for Contract Year 2013 and Other Changes (CMS)

FDA Information

• FDA Opens Innovation Pathway to First Round of Devices (Regulatory Focus)
• Report: New Troubles for Medical Device Manufactuers, FDA After Faulty Leads Lead to Questions (Regulatory Focus)
• FDA Guidance on Veterinary Antibiotic Use Prompts Compliance, Criticism (Regulatory Focus)
• Taylor: A Strategy to Keep Antimicrobials Effective (FDA)
• Hamburg Calls for New Authority, Strengthened Anti-Counterfeit Laws (Regulatory Focus)
• Hamburg: FDA Looking to Increase Port Inspections (Regulatory Focus)
• CDRH Releases New Training Module for Guidance on Benefit-Risk Determinations (Regulatory Focus)
• As St. Jude Spat Escalates, FDA Looks to Additional Device Surveillance (Regulatory Focus)
• Standards Board Warns of Potential Device Hacking, Calls for Increased FDA Authority (Regulatory Focus)
• FDA Gets New COO (Regulatory Focus)
• FDA Presentation Highlights Dramatic Need for GDUFA Legislation (Regulatory Focus)
• CDRH Seeks To Expand Public-Private Medical Device Epidemiology Network (The Gray Sheet)
• FDA approves imaging drug Amyvid  (FDA)
• FDA – Policy for Responding to Allegations of Research Misconduct by FDA Staff (FDA)
• FDA/CDER Small Business Chronicle (FDA)
• Connecting The FDA And Pharma / Biotech Industry (Life Science Leader)

Other US News

• New Bioethics Chief Takes Helm at White House (Regulatory Focus)
• First Targeted Nanomedicine to Enter Clinical Trials (Regulatory Focus)
• Eli Lilly Gets Approval for Brain Plaque Test (Regulatory Focus)
• Fed Up With Medical Device Lag, Some Patient Seek Obesity Treatment in Canada (Regulatory Focus)
• J&J looks for workaround to ease Doxil shortage (Fierce Pharma)
• Abbott drug tops sales as Lipitor, Plavix era ends (Reuters)
• Michael J. Fox Foundation Releases Clinical Trial Finder Tool (Biotech Now)
• Mytrus launches iPad informed-consent application (Pharma Times)
• Pharma industry seeks track-and-trace law (Packaging Digest)
• FDA decision on Vivus’ obesity drug delayed three months (PM Live)
• Calif.'s Prescription-Drug Monitoring System Feels Pain From Budget Cuts (NPR)
• Pain-Pill Crackdown Spreads (WSJ)
• Area drug experts alarmed at proposals for stronger painkillers (Enterprise News)
• California, Vermont consider tougher vaccine-exemption rules (AMA)

Legislative Update

• GPhA: Congress Should Move Ahead on User Fees (Regulatory Focus)
• Congressmen Pressure FDA, FCC Over Wireless Health Regulation (Regulatory Focus)
• Next PDUFA, MDUFA Hearings Scheduled for 18 April (Regulatory Focus)
• Medical Device Tax: Sen. Scott Brown continues to push repeal message on the stump (Mass Device)
• Pressure grows on drug firms to sever ties with conservative group after Trayvon shooting (The Hill)
• Senate Accelerated Approval Draft Needs “FAST” Changes, House Members Say (The Pink Sheet Daily)

The Courts

• Report: User Fees Could Be In Peril in Partisan Congress (Regulatory Focus)
• Arkansas Slams J&J With $1.2 Billion Fine for Risperdal Marketing Tactics (Regulatory Focus)

Workshops & Meetings

• CDER Small Business Webinar on the Guidance for Industry - Time and Extent Applications for Nonprescription Drug Products (2011) - April 16, 2012 (FDA)
• Meetings: Cardiovascular and Renal Drugs Advisory Committee (FDA)
• Nonvoting Industry Representatives; Notification and Nominations Request: Blood Products Advisory Committee (FDA)
• Medical Countermeasures Initiative Regulatory Science Symposium (FDA)
• Announcement of Requirements and Registration for “Reporting Patient Safety Events Challenge” (DHHS)
• Science Board to the Food and Drug Administration; Notice of Meeting (FDA)
• Request for Notification From Industry Organizations Interested in Participating in the Selection Process for Nonvoting Industry Representative on the Blood Products Advisory Committee, and Request for Nominations for Nonvoting Industry Representatives on the Blood Products Advisory Committee (FDA)
• Clinical Effectiveness Research Innovation Collaborative (IOM)
• Developing the Capabilities for Device Surveillance through the Medical Device Epidemiology Network (Brookings)

Compliance Issues

• New Safety Warning Issued For Popular Birth Control Product, Potentially Rekindling Controversy (Regulatory Focus)
• Four Disbarred By FDA Over Egregious Quality Mishaps (Regulatory Focus)
• FDA stops enrolment at all BioMed IRB-approved trials (Outsourcing Pharma)
• Class 1 Recall: Troponin I STAT Immunoassay (FDA)
• Health One Pharmaceuticals Inc (CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated)
• Christian Hospital Northeast-Northwest (IRB)
• ThyssenKrupp Access Manufacturing, LLC (CGMP/QSR/Medical Devices/Adulterated)

EU News

Regulation and Guidance

• SCENIHR -  Nanosilver: safety, health and environmental effects and role in antimicrobial resistance (EC)
• EMA Releases New Summary of Biosimilar Regulatory Procedures (Regulatory Focus)

EMA Information

• EMA Looks to Open Up Clinical Trial Data After Concerns About Tamiflu Raised (Regulatory Focus)

Other EU News

• Abadie Resignation Partially the Result of Lack of Compensation (PM Live)
• EFPIA seeks vendors for EU medicine verification system (Securing Pharma)

Meetings and Workshops

• EMA Holds Workshop on Use of Medicines in the Elderly (Regulatory Focus)

Global Regulatory News

• Africa – USP Announces Anti-Counterfeit Program (USP)
• Africa - New project launched in Africa to improve regulatory pathways and deliver better health products (GHTC)
• Australia – Summary of disinfectant regulation (TGA)
• Australia - Reforms to the regulation of hard surface disinfectants (TGA)
• Australia - The regulation of disinfectants and sterilants (TGA)
• Brazil: New Brazilian Standards For Breast Implants (Regulatory Focus)
• Brazil - New Advisory on Risks of Radiotherapy (Regulatory Focus)
• Brazil - New OTC Drug Marketing Opportunities (Regulatory Focus)
• Brazil - Anvisa Reorganization Published (Regulatory Focus)
• Brazil - Brazil, Mexico access to expensive cancer drugs "improving" (Pharma Times)
• India - Report: Regulations Banning Industry Gifts in India Still Taking Shape (Regulatory Focus)
• India - Report: India Boosting Ability to Regulate Clinical Trials (Regulatory Focus)
• India: New Proposal Could Allow Third-party Drug Quality Audits in India (Regulatory Focus)
• Korea - Device Safety Reassessed (Regulatory Focus)
• Russia: New Clinical Trial Regulations In Effect (Regulatory Focus)

Important Studies, Whitepapers and Research

• After Flu Concerns, Regulators Look to Issue Guidelines on ‘Dual Use’ Preclinical Studies (Regulatory Focus)
• Study Calls for Changes to FDA Treatment of Generic Competition (Regulatory Focus)
• Taxonomy For Monitoring Methods Within A Medical Product Safety Surveillance System: Year Two Report Of The Mini-Sentinel Taxonomy Project Workgroup (Mini Sentinel)
• Is high spending on cancer care 'worth it'? (Reuters)
• Mom's obesity tied to child's autism, development: study (Reuters)
• Evidence Of Banned Antibiotics Found In Poultry Products (Medical News Today)
• A pharmacist-led information technology intervention for medication errors (PINCER): a multicentre, cluster randomised, controlled trial and cost-effectiveness analysis (Lancet)
• Editors Retract 193 Studies Written by Japanese Anesthesiologist  (Science Magazine)
• Study finds high-impact medical journals guilty of anti-industry bias (ACRE)

Other News and Interesting Reads

• Things Regulatory Professionals Shouldn’t Do: Vincent McCrudden, Ex-Wall St. Trader, Sentenced To Prison For Threatening To 'Kill' Top Regulators (Huffington Post)
• Returning Military Vets Face a ‘A fog of drugs and war’ (LA Times)
• New concerns rising over antimalaria drug (Marine Times)
• For Feds, 'Lying' Is a Handy Charge (WSJ)
• Hospitals scramble on the front lines of drug shortages (The Washington Post)
• The War on Cancer: More Americans are surviving. Here's why (AARP)
• Drugs vs Mobile: Two Ways To Create $1B in Value (Forbes)