Regulatory Focus: Week in Review (4-8 June)

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.

Previous Week in Reviews: [28 May-1 June] [21-25 May] [14-18 May] [7-11 May] [1-4 May] [23-27 April]

Top News Items

Judge: Regulatory Inspection Report Can Form Basis of Class Action Lawsuit
On Monday, 4 June a federal appeals court ruled a securities fraud class action lawsuit could proceed against pharmaceutical manufacturer KV Pharmaceuticals for purportedly causing $1.5 billion in shareholder losses after first misleading the US Food and Drug Administration (FDA) about manufacturing problems at a facility and later shutting down the facility's manufacturing operations.

New FDA Guidance Could See Patients Obtaining Quicker Access to Experimental Therapies
The US Food and Drug Administration's (FDA) newly released draft guidance on neoadjuvant breast cancer treatments has the potential to radically change the existing pathway through which patients with aggressive early-stage breast cancer can obtain treatment, say experts.

EMA Looks Back on a Tough Year as it Forges Ahead
Kent Woods wants stakeholders to know he understands: 2011 was a tough year. As Chair of the European Medicines Agency's (EMA) Management Board and head of the UK's Medicines and Healthcare products Regulatory Agency (MHRA), Woods has had a front seat to many of Europe's most difficult regulatory problems.

Reforms to FDA's Medical Device Disagreement Policies Needed, Says Report
A new government report looking at scientific disagreements within the US Food and Drug Administration's (FDA) medical device branch recommends a number of changes at the agency after a series of high-profile disagreements between staff brought on unwanted media attention.

Regulatory Focus Features

• A Conversation With FDA's Human Factors and Accessible Medical Technology Expert (Regulatory Focus)
• How Safe Are Biosimilars? Implications of FDA and EMA Guidances and European Experience since 2006 (Regulatory Focus)
• ClinicalTrials.gov: Requirements and Implementation Strategies (Regulatory Focus)

US News

Medical Devices

• Will EMRs Drive Adoption of New Software Synchronization Abilities? (Regulatory Focus)
• Reforms to FDA's Medical Device Disagreement Policies Needed, Says Report (Regulatory Focus)
• FDA Looks to Extend Medical Device-focused Emergency Planning System (Regulatory Focus)
• Shuren: 510(k) guidance still on despite House opposition (Medical Device Daily)
• Smith & Nephew pulls metal-on-metal hip component (Reuters)
• CDRH's Shuren Offers Update On "Network Of Experts" Program (The Gray Sheet)
• FCC Chairman Genachowski Hosts mHealth Summit to Foster Innovation in Wireless Health Technology (FCC)
• Neuronetics' depression therapy device wins CE Mark | Regulatory Roundup (Mass Device)
• FDA inspected school using shocks on students (CNN)

Pharmaceutical and Biologics

• New FDA Guidance Could See Patients Obtaining Quicker Access to Experimental Therapies (Regulatory Focus)
• FDA Releases Final ICH Guidance on Genotoxicity Testing and Data Interpretation (Regulatory Focus)
• Study: FDA Recall Communication System Ineffective, Poorly Designed (Regulatory Focus)
• Hamburg Continues to Call for More Anti-Counterfeiting Authority (Regulatory Focus)
• FDA Anticipates Spike in Oncology Drugs, Reduction in Shortages (Regulatory Focus)
• Report: Compounding Regulatory Issues Come to Light After 'Urgent' Recall (Regulatory Focus)
• Post-FDAAA, Regulators Move to Adapt to Changing Risk Models (Regulatory Focus)
• FDA Looking to Speed up Public Notification of Recalls (Regulatory Focus)
• Lone Wolfe: Drug Industry Critic Ends Tenure As Advisory Committee Member With Rare Decisive Vote (The RPM Report)
• FDA Science and Research Working to Uncover the Immunology of Severe Drug Reactions (FDA)
• US hospitals fight drug scarcity, fear patients harmed (Reuters)
• FDA Announces Minor Use/Minor Species (MUMS) Grant Program Request for Applications Due July 20, 2012 (FDA)
• FDA Panel Looks Beyond Xarelto's Missing Data Problems To Broader Reforms (The Pink Sheet)
• FDA Science and Research Working to Uncover the Immunology of Severe Drug Reactions (FDA)
• Former CRO Employee Stole Merck Compounds (Pharmalot)
• Tablet Size Citizen Petition Filed by Osmotica for Extended-Release Venlafaxine Hydrochloride (FDA Lawyers Blog)
• Drug's Nickname May Have Aided Politicization (The New York Times)
• Rx Safety Communication In Face Of Uncertainty, Multiple Risks, To Be Examined By FDA Panel (The Pink Sheet Daily)
• Deal Reached on Online Prescription Reporting (The New York Times)
• Pharmacists ask FDA for biosimilar substitution (Biosimilar News)
• Pfizer Lyrica Citizen Petition Against Generics Argues Drug Impurities Should Have Ceiling, Not Floor (The Pink Sheet Daily)
• Registry for naming biosimilars needed, author says (Drug Topics)
• FDA Rejects Merck Sarcoma Drug (Med Page Today)

Other US News

• New Tool Promises to Make Federal Regulations Easier to Find (RegBlog)
• PCORI releases methodology standards (PCORI)
• Interview with FDA: Adopting New Strategies to Oversee Global Economy (Biopharm International)
• FDA's Medical Countermeasures initiative - Protecting Public Health (FDA)
• FTC Could Revise its Dot Com Disclosures Guidelines by Fall 2012 (FDA Law Blog)
• A Conversation with Head of the FDA (TED)
• Dr. Margaret Hamburg's Advice to Graduates (YouTube)
• Medical boards get more tools to investigate physicians (American Medical News)
• Vaccines for U.S. children may not be properly stored: study (Reuters)

Legislative Update

• Congressional Research Service Releases Side-by-side Analysis of User Fee Bills (Regulatory Focus)
• As House Prepares to Appropriate FDA Funding, Sequestration Process Looms Large (Regulatory Focus)
• User Fee Bills Would End Unique Device Identifier Stalemate (Regulatory Focus)
• Proposed Legislation Would Allow for Conditional Clearance of Medical Devices (Regulatory Focus)
• Group Calls for Changes to User Fee Bill After Transparency Concerns Emerge (Regulatory Focus)
• User Fee Conference Cmte. Could Be Relatively Messy After Clean Floor Votes (The Pink Sheet)
• House Judiciary Markup of the Counterfeit Drug Penalty Enhancement Act of 2011 (House)
• Device Tax: House Ways & Means OKs repeal bill (MassDevice)
• White House Threatens Veto of Device Tax if Passed (White House)
• Examining the Appropriateness of Standards for Medical Imaging and Radiation Therapy Technologists (House)
• Sen. Franken: Encrypt laptops with medical info (CBS)
• FDA Asked to Take Ban Use of Pesticide for Head Lice (Medpage Today)
• Pharmacy Groups Oppose Reclass of Hydrocodone (Med Page Today)
• Casey urges national ban on synthetic drugs (Tribune-Democrat)
• ACRO Pushes Global Trials Language in PDUFA (ACRO)

The Courts

• Judge: Regulatory Inspection Report Can Form Basis of Class Action Lawsuit (Regulatory Focus)
• FDA Appeals Antibiotic Decision, Earning Congresswoman's Ire (Regulatory Focus)
• Judge Calls FDA Decision on Antibiotics 'Arbitrary and Capricious,' Urges Reconsideration (Regulatory Focus)
• Supreme Court: Decision Nears on 'Obamacare' (Medpage Today)
• FDA Misdemeanor Cases-Not Always A Sure Win for the Government (FDA Law Blog)

Compliance and Safety Issues

• Warning Letter Analysis: Medical Device Companies Cited for Marketing Unapproved Products (Regulatory Focus)
• Warning Letter Analysis: FDA Cracks Down on Companies With Unregistered Facilities (Regulatory Focus)
• J&J Announces Planned Cessation of Vaginal Mesh Sales (Regulatory Focus)
• Sandoz Issues Recall After Packaging Errors Found (Regulatory Focus)
• Pfizer Withdraws Indication for RA Drug After It Fails to Complete Required Study (Regulatory Focus)
• FDA issues alert on Reumofan Plus (FDA)
• Stryker to take charge to end US knee-device probe (Reuters)

Workshops & Meetings

• DrugSafety and Risk Management Advisory Committee
• Muzzle pharma, harm patients: The dangers of anti-industry bias (American Enterprise Institute)

EU News

Regulation and Guidance

• EMA Issues Guidance on Risk Assessment of Potential Medication Errors (Regulatory Focus)

EMA Information

• EMA Looks Back on a Tough Year as it Forges Ahead (Regulatory Focus)
• European Ombudsman Chides EMA for Transparency Problems (Regulatory Focus)
• Compilation of QRD decisions on stylistic matters in product information (EMA)
• Rasi At The EMA: Redefining Benefit/Risk As Staggered Approvals Rise (The Pink Sheet)
• Compilation of Community Procedures on Inspections and Exchange of Information (EMA)
• Clinical Trials Directive to be published in June (EU Geriatric Medicine Society)

Other EU News

• EU: Pharma companies begin verified supply chain (New Europe Online)
• EU: AstraZeneca V. EC - The Advocate General's Opinion (Covington & Burling) (PDF)
• UK: MHRA Rolls Out First-ever Information Leaflet Specifically Aimed at Children (Regulatory Focus)
• UK: ABPI 'fears for future of UK research' ahead of pricing talks (InPharm)
• UK: Home visits = regulatory thumbs up? ResearchNurses.co thinks so (Outsourcing Pharma)
• UK: Medical Device Alert: Anaesthetic machines and associated devices, all manufacturers (MHRA)
• UK: MHRA Releases New Guidance for Impending Changes to Labeling Regulations (Regulatory Focus)
• UK: Bayer's Blood Clot Drug Gets Draft OK From NICE (Regulatory Focus)
• France Issues New Advertising Guidelines (Regulatory Focus)
• France: HAS Posts Overview of HTA Public Consultations (Regulatory Focus)

Global Regulatory News

• Australia: Skerritt Takes Reins as New Head of TGA (Regulatory Focus)
• Australia: Complementary medicines regulatory reforms (TGA)
• Australia: Implant rupture rates uncertain: report (Sydney Morning Herald)
• Brazil: Regulatory Agency Gets Authority to Deny Patents (Regulatory Focus)
• Brazil: New Quality Standards for Excipients (Regulatory Focus)
• Canada: Health Canada To Develop Guidance Clarifying Drug/Device Classification (Regulatory Focus)
• Canada: Announcement of meeting and invitation to participate - Scientific Advisory Committee on Pharmaceutical Sciences and Clinical Pharmacology (Health Canada)
• China: New Draft Rules On Excipients (Regulatory Focus)
• China: SFDA Proposes Blacklisting Companies (Regulatory Focus)
• China: 2011 Adverse Reaction Report Released (Regulatory Focus)
• Italy Faces Regulatory Hurdles After Earthquakes Slam Life Science Industry (Regulatory Focus)
• South Korea: Approved Viagra copies flood drugstores in Korea (Reuters)

Important Studies, Whitepapers and Research

• Study: Less Affluent Less Likely to Participate in Clinical Trials (Regulatory Focus)
• Medicines as a Service: A New Commercial Model for Big Pharma in the Postblockbuster World (RAND)
• Concerns About Pharmaceuticals, Personal Care Products And The Environment (Medical News Today)
• Drug Helps Defense System Fight Cancer (The New York Times)
• ASCO Roundup: Key news from Bayer, Aveo, J&J and Seattle Genetics (Fierce Biotech)
• Prescription Drug Monitoring System Is Necessary According To Researchers (Medical News Today)
• Pentagon seeks to speed up biotech research (Fierce Health IT)
• Assessments of the Impact of FDA's Regulatory Actions and Interventions (Mini Sentinel)

Regulatory Reads

• Biomanufacturing Shows Signs of Maturity, PAT Adoption (Pharma Manufacturing)
• cGMPs and Statistics: FDA's Rick Friedman and Karthik Iyer explain why some manufacturers need to get a better grip on GMP-related statistics. (Pharma Manufacturing)
• Real-Time Viable Particle Detection: Benefits, Challenges, and Regulatory Needs (Pharma Manufacturing)
• Biopharma's Flexible Imperative (Pharma Manufacturing)
• Is FTC Becoming an All-Purpose Health Care Cost Regulator? (Forbes)
• New Cancer Data Shine Spotlight On The Secret Committees That Make Medicine's Toughest Decisions (Forbes)
• J&J Prostate Cancer Trial Shouldn't Have Been Stopped Early (Xconomy)

Other News and Interesting Reads

• A Game to Help Doctors Ask Tough Questions (The New York Times)
• You get who you pay for: The economic case for bribery (The Economist)
• Abortion Qualms on Morning-After Pill May Be Unfounded (The New York Times)
• The Trouble With 'Doctor Knows Best' (The New York Times)
• Cheap vs. Expensive Drugs (The New York Times)
• Pharma's Missing Link: Former NIH Head Elias Zerhouni Tries to Save the Pharmaceutical Industry (Forbes)