Regulatory Focus: Week in Review (14-18 May)

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 the 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: [7-11 May] [1-4 May] [23-27 April] [16-20 April] [9-13 April]

Top News Items

White House Throws Support Behind Senate User Fee Bill (Regulatory Focus)
The Obama Administration has indicated it "strongly supports passage" of user fee legislation currently in the US Senate, saying it will "help speed safe and effective drugs, medical devices and biosimilar biological products to patients."

FDA Quicker Than EMA, Health Canada for Drug Approvals, Says NEJM Report (Regulatory Focus)
A study published in the New England Journal of Medicine claims the US Food and Drug Administration (FDA) approves drugs faster than the European Medicines Agency (EMA) or Health Canada.

European Parliament Still Dissatisfied With EMA Conflict of Interest Policies (Regulatory Focus)
The European Parliament is still refusing to sign off on the European Medicines Agency's (EMA) 2010 budget expenditures, the latest development in a long-running fight over the agency's credibility, reports Science Magazine.

Report: 'Dramatic' Increase in Q1 Medical Device Recalls (Regulatory Focus)
A new report tracking medical device recalls during the first quarter of 2012 shows a massive spike in medical device recalls, reversing a fourth quarter (Q4) 2011 trend of reduced recalls.

Regulatory Focus Features

• ClinicalTrials.gov: Requirements and Implementation Strategies (Regulatory Focus)
• Demystifying Electronic Data Standards for Clinical and Nonclinical Studies (Regulatory Focus)
• Considering Risk Evaluation and Mitigation Strategies (REMS) (Regulatory Focus)

US News

FDA Information: Medical Devices

• Security Agency Warns About Medical Device Vulnerabilities (Regulatory Focus)
• OTC Test for HIV Approved by FDA Advisory Panel (Regulatory Focus)
• FCC Pushing to Release New Spectrum for Medical Devices (Regulatory Focus)
• Report: 'Dramatic' Increase in Q1 Medical Device Recalls (Regulatory Focus)
• Relying on In Silico Trials, FDA Approves Outpatient Testing for Smartphone-Based Artificial Pancreas (MD+DI)
• Weight loss: FDA panel wants a higher bar for medical devices aimed at curbing obesity (Mass Device)
• Upcoming Webinar on Hearing Aids: The Basic Information You Need to Know (EMA)

FDA Information: Pharmaceutical and Biologics

• New FDA Program Aims to Develop New Approaches to Clinical Trials, Pharmacovigilance (Regulatory Focus)
• Biotechnology Companies Seek Changes, Clarification in Biosimilar Draft Guidance (Regulatory Focus)
• FDA Releases New ICH Guidance on Preclinical Safety Evaluation (Regulatory Focus)
• FDA Panels Clear Arena Pharmaceuticals' Obesity Drug, Gilead Sciences' HIV PrEP (Regulatory Focus)
• CDER Ombudsman: Smaller Companies Feel Confusion, Pinch of Regulations (Regulatory Focus)
• CBER Releases Strategic Plan for 2012-2016 Period (Regulatory Focus)
• US, British Pharmacopoeias Tout Effort to Harmonize Drug Standards (Regulatory Focus)
• Minor Changes Planned For User Fee Application Forms (Regulatory Focus)
• FDA Issues New Recommendations for MS Drug After Cardiovascular Concerns Raised (Regulatory Focus)
• Warning and NOV Letter Summary - 1st Quarter 2012 (Eye on FDA)
• FDA panel OKs Gilead's key HIV drug Quad (Fierce Biotech)
• USP Introduces Useful Guidelines on Sterilization and Contamination Control (PharmPro)

FDA Information: Other News

• FDA's Travel Budget Could be Cut Dramatically Under New Order (Regulatory Focus)
• UPDATED: Report: FDA Quicker Than EMA, Health Canada for Drug Approvals (Regulatory Focus)
• Report: Outsourcing of Regulatory Services Rising Dramatically (Regulatory Focus)
• FDA Basics Webinar: FDA Office of Minority Health - Steps to Address Health Disparities (FDA)
• RX-to-OTC proposal gets mixed reviews (Medical Marketing and Media)

Other US News

• CROs Can't Recruit Patients Fast Enough: Survey (Pharmalot)
• U.S. launches ambitious Alzheimer's plan with research push (Reuters)
• Addiction Diagnoses May Rise Under Guideline Changes (The New York Times)
• Advocates warn automatic cuts would hit medical research (The Hill)
• California Board of Pharmacy weighs in on RxTEC proposal (Securing Pharma)
• Request for Information Regarding the NIH-Industry Program To Discover New Therapeutic Uses for Existing Molecules (NIH)
• Army Looking to Clinical trials to size up antipsychotics like Seroquel for PTSD (Fierce Pharma)
• Announcement of Requirements and Registration for "Ocular Imaging Challenge" (DHHS)

Legislative Update

• Senator Looks to Spur Development of Medicines Through 'Prize Fund' (Regulatory Focus)
• Republicans Ramp up Pressure on White House Over PPACA Negotiations (Regulatory Focus)
• New Provisions in Senate User Fee Bill as Vote Scheduled (Regulatory Focus)
• White House Throws Support Behind Senate User Fee Bill (Regulatory Focus)
• After Numerous Delays, Legislation to Curb Drug Shortages to Advance in Congress (Regulatory Focus)
• Proposed Bill Would Mandate Passage of Device Identifier, Data Collection (Regulatory Focus)
• New Bill Would Subject Regulations to Quadrennial Legislative Review (Regulatory Focus)
• User Fees Expected to Save Taxpayers $358M Over Next Ten Years (Regulatory Focus)
• PDUFA Scrubbing: How The House User Fee Bill Got So Agreeably Clean (The Pink Sheet)
• House Moves Closer To Senate On FDA Bill (The Gray Sheet)
• Consumer group wary of industry concessions in FDA user fee bill (Fierce Medical Devices)
• Reid notes wife's battle with cancer as Senate starts work on FDA bill (The Hill)
• Hearing: Full Committee Field Hearing - Ensuring Patients' Access to Care and Privacy: Are Federal Laws Protecting Patients? (HELP Committee)
• Generics: Capitol Hill's Super "Pay For" (The Pink Sheet Daily)
• Approving "Breakthrough" Drugs Fast (The Scientist)

The Courts

• Cardinal Health won't ship pain pills from Florida facility under DEA deal (Philly Pharma)
• Contraception lawsuit puts Obama on the spot (Politico)
• After a Sentence to Write Sentences, Dr. Bodnar Ends a Legal Chapter (WSJ)
• Whistleblower Suit Claims Pioglitazone Cover-up (MedScape News)
• DePuy's BMJ fray: Is the hip maker showing its hand ahead of jury trials? (Mass Device)
• Plavix Set to Lose Patent Protection (The New York Times)
• Skechers Will Pay $40 Million to Settle FTC Charges That It Deceived Consumers with Ads for "Toning Shoes" (FCC)
• Lawsuit: Whistleblower accuses Medtronic of installing crony in spine journal to promote Infuse (Mass Device)

Compliance and Safety Issues

• Warning Letter Analysis: FDA Warning Letters Cite Companies for Marketing, cGMP, Design Deficiencies (Regulatory Focus)
• Warning Letter Analysis: Companies hit for cGMP, Reporting Violations (Regulatory Focus)
• cGMP Violations Could Lead to Three Years in Jail for Former Medical Device Executive (Regulatory Focus)
• FDA warning hurts Hikma generics margins (Reuters)
• Hospira Recalls Pain Drug Cartridges on Over-fill Concerns (WSJ)
• BMJ Editor Defends Hip Implant Article (MedTechInsider)
• Researchers Duel Over Chantix And Heart Risks (Pharmalot)
• New Cautions About Long-Term Use of Bone Drugs (The New York Times)
• Infupharma, LLC - FDA Form 483 (FDA)
• May 8, 2012: Medical Device Distributor Sentenced For Importing, Reselling Counterfeit and Contaminated Surgical Hernia Mesh (FDA)

Workshops & Meetings

• Meetings: Blood Products Advisory Committee (FDA)
• Patient-Centered Outcomes Research Institute Will Discuss Approval of Revised National Priorities for Research and Research Agenda at Denver Board Meeting (PCORI)
• Educational Forum on Medical Device Reporting, Complaint Files, and Recalls, Corrections, and Removals (FDA)

Deals and Acquisitions

• Buzz: Big Pharma suitors line up for a look at Amylin's books (Fierce Biotech)

EU News

Regulation and Guidance

• Specific Privacy Statement for Public Consultations (EMA)
• Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials (EMA)

EMA Information

• EMA Launches Mandatory Training Course to Help MAHs Comply with EudraVigilance Regulations (Regulatory Focus)
• EMA Issues Guidance for Companies Seeking Scientific Advice (Regulatory Focus)
• EMA's Rasi Moves to Streamline Conflict of Interest Policies (Regulatory Focus)
• Committee Calls for Improved Pharmacovigilance, New Labeling Requirements in Europe (Regulatory Focus)
• European Parliament Still Dissatisfied With EMA's Conflict of Interest Policies (Regulatory Focus)
• European Parliament 'not amused' with EMA failures (PMLiVE)
• European Commission's Definition Roils Industries with Eye on Nanomaterials (GEN)

Other EU News

• Europe: Improving the prospects for ATMPs in Europe (PMLiVE)
• Europe: 222 EU health claims become law; experts predict "tsunami of cheap innovation" (NutraIngredients)
• Europe: patient group demands action on off-label safety (Pharma Times)
• France: French drugmaker on trial over weight-loss pill (Reuters)
• France: Call for Applications for the Establishment of the Scientific Council of the National Security Agency of Medicines and Health products (ANSM) (PDF)
• Ireland: Irish Medicines Board Announces Transition to Fully Electronic Submission System (Regulatory Focus)
• UK: Study: Some Drugs Waiting up to Nine Years for NICE Approval (Regulatory Focus)
• UK: Rising UK Drug Shortages Highlight MHRA's Oversight Problems (Regulatory Focus)
• UK: MHRA Working to 'Quickly Implement' Recommendations from Commission (Regulatory Focus)
• UK: Price Cut Opens Access to New Prostate Cancer Drug (Regulatory Focus)
• UK Publishes Review of PIP Breast Implant Scandal, Calls for Improvements (Regulatory Focus)
• UK: New Prostate Cancer Drug Extends Life, But NICE Against Reimbursement (Regulatory Focus)
• UK: NICE comes out fighting against appraisal delays story (InPharm)
• UK: NICE should produce guidance on multiple morbidities (NICE)
• UK: NICE rethinking value of long-term benefit (BioCentury)

Global Regulatory News

• Australia: TGA Warns of Increased Wear for Riata Cardiac Leads (TGA)
• Brazil: New Agreement Paves Way for Manufacturing Facilities to Produce Multiple Drug Types (Regulatory Focus)
• Brazil: South American Countries Driving Regulatory Harmonization (Regulatory Focus)
• Brazil: Anvisa Restructuring to Meet Social, Economic Development Goals (Regulatory Focus)
• Canda: Standard Operating Procedures (SOP) - Using the Pharmaceutical Safety and Efficacy Assessment Template for Advanced Consideration of Requests for Notice of Compliance with Conditions or Priority Review (PSEAT-AC) to Prepare Reports (Health Canada)
• Canada: Using the Pharmaceutical Safety and Efficacy Assessment Templates (PSEATs) to Prepare Reports on Submissions for Marketing Authorizations (Health Canada)
• Canada: New Canadian Regulations Would Dramatically Expand Prescribing Authority (Regulatory Focus)
• China: SFDA Amends OTC Manual for Amantadine Hydrochloride Compounds (Regulatory Focus)
• China: Capsule safety scandal to put prices up (China Daily)
• GMNDA: New partnership to boost use of GMDN codes for medical devices (Mass Device)
• ICH Looking to Establish New Harmonized Guideline on Carcinogenicity Testing (Regulatory Focus)
• ICH Releases Update for E14 Guideline on Clinical Evaluation of Non-Antiarrhythmic Drugs (Regulatory Focus)
• ICH Finishes Q11 Quality Manufacturing Guideline, Prepares to Notify Regulators (Regulatory Focus)
• India: As India Moves to Investigate Claims of Collusion, US Could Increase Scrutiny (Regulatory Focus)
• India: Government plans a crackdown on pharma firms selling drugs as dietary supplements (The Economic Times)
• India: Pharmaceutical companies such as Cipla, Sun Pharma deny wrongdoing in introducing new drugs (The Economic Times)

Important Studies, Whitepapers and Research

• NIH-led study finds genetic test results do not trigger increased use of health services (NIH)
• Unleashing value: The changing payment landscape for the US pharmaceutical industry (PWC)
• The U.S. currently leads the world in medical innovation. But for how long? (PhRMA)
• Researchers engineer edible malaria vaccine (Fierce Vaccines)

Regulatory Reads

• Researchers Gauge Effects of Regulatory Systems on Counterfeit Medicines (Regulatory Focus)
• Should A Federal Agency Oversee The DSM? (Pharmalot)
• Women in Medtech: FDA's Christy Foreman Urges Students to Find a Mentor (MD+DI)
• Behind the Burden of Regulation (The New York Times)
• FDA & EMA Regulatory Developments for eSubmissions (GxP Perspectives)

Other News and Interesting Reads

• What's the most cost-effective way to dispose of medications? Just throw them out (The Scientist)
• Dangerous Doses: Fighting Fraud in the Global Medicine Supply Chain (Foreign Affairs)
• Paralyzed, Moving a Robot With Their Minds (The New York Times)
• Can You Call a 9-Year-Old a Psychopath? (The New York Times)