Regulatory Focus: Week in Review (16-20 April)

Latest News | Posted: 20 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: [9-13 April] [2-6 April] [26-30 March]

Top News Items

Drafts of PDUFA, MDUFA Released in House, Senate
Congressional committees responsible for the oversight of the US Food and Drug Administration (FDA) released discussion drafts intended to start the debate over the reauthorization of the Prescription Drug User Fee Act (PDUFA) and Medical Device User Fee Act (MDUFA).  More »

New Pilot Seeks to Dramatically Speed up 510(k) Reviews
A new pilot program announced by the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health aims to dramatically speed up 510(k) medical device reviews for manufacturers of certain in vitro diagnostic and radiology products. More »

Indian Drug Regulator's Office in Limbo
The Economic Times of India reports the Drug Controller General of India (DCGI), the regulatory body in charge of approving drugs and clinical trials, exists in a state of "limbo" after a series of power struggles and vacancies. More »

SCOTUS Rules Company Can Sue Novo Nordisk For Delaying Generic
The Supreme Court of the United States ruled 17 April that Caraco Pharmaceuticals can proceed with a lawsuit against Novo Nordisk over Nordisk's purported attempts to prevent Caraco's generic entry into the market. More »

Regulatory Focus Features

• Perspective: A Modern Progressive Approval System for Rare Diseases (Regulatory Focus)
• A Closer Look at Strategic Alliances Between Drugmakers and CROs (Regulatory Focus)
• Mastering the eCTD Format Critical for Regulatory Submissions Pros (Regulatory Focus)

US News

FDA Information

• CDRH: New Pilot Seeks to Dramatically Speed up 510(k) Reviews Based on High Regulatory Quality
• Hamburg: ‘I Understand the Frustration’ With Inefficient Regulations (Regulatory Focus)
• As Mobile Applications Cross Over Into FDA Regulatory Territory, New Frictions Emerge (Regulatory Focus)
• Report: Future of FDA’s $280 Million IT Improvement Program ‘Uncertain’ (Regulatory Focus)
• FDA Plans Study on How Obese Patients Make Decisions, Perceive Risk (Regulatory Focus)
• FDA In Process of Translating Many Publications, Guidances (Regulatory Focus)
• For Terminally Ill Patients, ‘Life Spans Shorter Than FDA’s Approval Process’ Spurs DIY Medicine (Regulatory Focus)
• After Counterfeit Avastin Infiltrates Supply Chain, FDA Goes After Doctors (Regulatory Focus
• Report: Comments on Draft Biosimilar Guidelines Mostly Trend Negative (Regulatory Focus)
• Texas Approves New Stem Cell Therapies, Setting up Possible FDA Showdown (Regulatory Focus)
• Former FDA Commissioner Says Lack of Resources to Blame for Lack of Innovative Approvals (Regulatory Focus)
• FDA, South Dakota in Tussle Over Regulation of Lethal Injection Drug (Regulatory Focus)
• Sixteen Drugs Identified by AERS as Potentially Having Serious Risks (Regulatory Focus)
• Manufacturer Raided by US Marshals Service After FDA Finds Contaminated Ultrasound Gel (Regulatory Focus)
• Owe FDA Money? Don’t Bother Submitting an Application, Says CDER (Regulatory Focus)
• U.S. Device Approvals "as Fast or Faster" than in Europe, says FDA's Hamburg (MDDI)
• Head of BIO advocates FDA chief innovation officer (Mass High Tech)
• Blood Clot Risk Of Drospirenone Products Remains Open Issue For FDA (The Pink Sheet)
• With better HIV tests, should FDA end its ban on gay men donating blood? (Washington Post)
• Valdez: Collaboration for a Global Product Safety Net (FDA)
• AGDUFA II Negotiations – 7 February (FDA)
• AGDUFA II Negotiations – 7 March (FDA)
• AGDUFA II Negotiations – 28 February (FDA)
• FDA: 'Trust but verify' (USA Today)
• Rx Drug Coupons Costly for Medicare (Med Page Today)
• FDA Reminds the Public about the Potential for Life-Threatening Harm from Accidental Exposure to Fentanyl Transdermal Systems (“Patches”) (FDA)
• CDRH Mission, Vision and Shared Values (FDA)

Other US News

• Report: Postmarketing Regulatory Troubles at St. Jude Depress Share Value (Regulatory Focus)
• IOM Report Envisions ‘Transformed Clinical Trials Enterprise’ in US (Regulatory Focus)
• J&J Earnings Drag as Regulatory Problems Accumulate (Regulatory Focus)
• PCORI Moves to Advance New CER-Centered Agenda (Regulatory Focus)
• After Regulatory Issues Raised, Medtronic Plans to Heighten Postmarketing Safety Monitoring (Regulatory Focus)
• Castellani Says PhRMA Looking to Uphold Affordable Care Act to Protect Regulatory Pathway (Regulatory Focus)
• Eli Lilly’s Leichleiter Replaces Sanofi’s Veibacher as PhRMA Chairman (Regulatory Focus)
• Device Malfunction Casts Doubt on Industry Oversight Pledge (New York Times)
• USP: Strengthening a Mutual Dedication to Quality Medicines in South Korea, U.S. (USP)
• Michael J Fox Foundation to test Sanofi Parkinson's drug (Pharma Times)
• PhRMA conferees fault industry for poor messaging (Medical Marketing and Media)
• Lack of interoperability hampers Rx tracking: Defense OIG (Modern Healthcare)
• CDC calls for better stewardship to combat C. difficile mortality (Drug Topics)
• Biopharma lobby members pumped $49.5B into R&D (Fierce Biotech)
• States Seek Curb on Patient Bills for Costly Drugs (New York Times)
• DEA Prescription Drug Abuse Crackdown Continues (FDA Lawyers Blog)
• Sales of prescription painkillers soar across the country (Journal Sentinel Online)
• Lack of interoperability hampers Rx tracking: Defense OIG (Modern Healthcare)
• Prescription Drug Abuse Drives Huge Spike In Poisoning Deaths Among Children: Report (Huffington Post)
• Abbott hit by cargo thieves once again (Securing Pharma)
• White House suggests new strategy for drug crimes (The Columbus Dispatch)
• Consumers will pay more for specialty drug coverage (Fierce Health Payer)
• In a Shift, Medicare Pushes Bids (New York Times)

Legislative Update

• Legislation to Make FDA’s Regulatory Calculus More Transparent Introduced in Congress (Regulatory Focus)
• New Bill Would Close Mensing Loophole (Regulatory Focus)
• Drafts of PDUFA, MDUFA Released in House, Senate (Regulatory Focus)
• Senator: Regulators and Medical Device Manufacturers Must Find Common Ground (Regulatory Focus)
• Senators Release Plan to Improve Pediatric Device, Drug Safety (Regulatory Focus)
• House Meets to Discuss PDUFA, MDUFA User Fees (Regulatory Focus)
• Generic User Fee Waivers Dropped In Latest House Draft Bill (The Pink Sheet Daily)
• Mass. Sen. hopeful Elizabeth Warren on the device tax, the FDA and a climate for innovation (mass Device)
• Political Sparring Stalls House Judiciary Markup (Courthouse News Service)
• Antibiotic Incentives: FDA’s Woodcock Says LPAD Could Offer Better Than Exclusivity, But Questions Remain (The Pink Sheet Daily)
• Markey fails to get movement on new medical device regulations (The Boston Globe)

The Courts

• Supreme Court Rules Company Can Sue Novo Nordisk For Delaying Generic Medication (Regulatory Focus)
• U.S. asks court to force J&J executive to testify (Hartford Courant)
• Justices Weigh Overtime Exemption for Drug Firm Representatives (New York Times)
• The Supreme Court and Biosimilars: What if it All Goes Away? (RPM Report)
• Absolutely, Totally, and in All Other Ways Inconceivable? Nope, Says the Federal Circuit in YASMIN Hatch-Waxman Method Patent Litigation (FDA Law Blog)

Workshops & Meetings

• FDA Plans Meeting to Explore Ways to Involve Patient Advocacy Groups in Regulatory Decision-making (Regulatory Focus)
• FDA Basics Webinar: “Mini-Sentinel,” FDA’s New Tool for Monitoring the Safety of FDA-Approved Medical Products (FDA)
• Public Workshop on Minimal Residual Disease (FDA)
• Maximizing the Goals of the Cures Acceleration Network to Accelerate the Development of New Drugs and Diagnostics: A Workshop (IOM)
• FDA Basics Webinar: “Mini-Sentinel,” FDA’s New Tool for Monitoring the Safety of FDA-Approved Medical Products (FDA)

Quality and Compliance Issues

• FDA Links Merck's Drugs to Sexual Side Effects (Med India)
• Notice of Recall: Franck’s Compounding Lab (FDA)
• FDA Calls Out Ferring For Sales Aid For Prostate Cancer Drug Firmagon That Cites Reduction In PSA Levels (The Pink Sheet Daily)
• DePuy ASR recall takes $271M from J&J's Q1 bottom line (Mass Device)

EU News

Regulation and Guidance

• EMA Invites Comments on ICH Risk-Benefit Guidance (Regulatory Focus)
• EMA Issues New Paper on Advancing Ethical Regulatory Framework for Clinical Trials (Regulatory Focus)
• New EMA Guideline on Real Time Release Testing (Regulatory Focus)
• EMA Releases Draft Guideline on Process Validation (Regulatory Focus)
• EMA Invites Comments on ICH Risk-Benefit Guidance (Regulatory Focus)
• EMA Releases Draft Reflection Paper on Tissue Engineered Products (Regulatory Focus)
• EMA Posts Revised Integrated Guidance on Use of Centralized Procedure (Regulatory Focus)
• Questions and answers on post approval change management protocols (EMA)

EMA Information

• EMA Work Instruction for Inspection Fees (EMA)
• Standard operating procedure related to veterinary medicinal products authorised in the European Union (EMA)
• Standard operating procedure related to pharmacovigilance measures for veterinary medicinal products authorised in the European Union

Other EU News

• UK: NICE Denies Avastin Indication for Breast Cancer (Regulatory Focus)
• EDQM Continuing Development of New, Comprehensive Anti-Counterfeiting Strategy (Regulatory Focus)
• European Commission Launches Prize Fund to Encourage Vaccine Temperature Stability (Regulatory Focus)
• Calls for greater public return on EU health R&D spend (Pharma Times)
• NHS England drugs bill falls as patents expire (Pharma Times)
• Pharma baffled by NHS’ moving target (InPharm)
• More warnings on metal-on-metal hip implants in U.K, New Zealand  (Mass Device)

Global Regulatory News

• Africa: S. Africa ratchets up protection for domestic drugmakers (Fierce Pharma)
• Australia: MITCH TRH Modular Head (used in hip replacements) - product cancellation (TGA)
• Brazil: New Risk Mitigation Regulation for Devices (Regulatory Focus)
• Brazil: Consultation Opened On OTC Drugs (Regulatory Focus)
• Brazil: ANVISA Publishes 2012 Regulatory Priorities (Regulatory Focus)
• Brazil: New Format Package Inserts for 135 Drugs Online (Regulatory Focus)
• Canada: Health Canada Issues Final Guidance On Pre-market Evaluation of Hepatotoxicity (Regulatory Focus)
• Canada: List of Recognized Standards for Medical Devices (Health Canada)
• Canada: CADTH Finds Urine Test as Good as Blood for Type II Diabetes Monitoring (Regulatory Focus)
• Canada: Record of Decisions - October 24, 2011, Canada's Research-Based Pharmaceutical Companies (Rx&D) (Health Canada)
• Canada: Guidance Document: Pre-market Evaluation of Hepatotoxicity in Health Products (Health Canada)
• CDISC Releases New Protocol Representation Toolkit (CDISC)
• China: SFDA halts sale of medicine in unsafe capsules (PharmPro)
• China Finds 13 Drugs Made With Excessive Levels of Chromium (Regulatory Focus)
• India: Report: Indian Drug Regulator’s Office Has ‘Washed Its Hands From Drug Approvals’ (Regulatory Focus)
• India: Ranbaxy to launch India's first indigenous malaria drug at one-third the cost of current therapies (Economic Times of India)
• India: Indian Task Force Recommends Adoption of Authentication System for Pharmaceuticals (Regulatory Focus)

Important Studies, Whitepapers and Research

• Researchers Say They Can Stop Medical Device Hackers From Gaining Unauthorized Access (Regulatory Focus)
• Dueling Reports Suggest Economic Impact of Regulations Uncertain (Regulatory Focus)
• Study: Canadian Off-Label Prescribing Common, Lacks ‘Strong Scientific Evidence’ (Regulatory Focus)
• Study: PIP breast implant failure rate higher than thought (Fierce Medical Devices)
• Cornell Maps Clinically Meaningful Ortho Device Attributes (The Gray Sheet)
• A Sharp Rise in Retractions Prompts Calls for Reform (New York Times)
• US insurer blames branded drugs for $2B annual spending "waste" (Pharma Times)
• Seniors In Medicare 'Doughnut Hole' More Likely To Stop Heart Drugs (NPR)
• White House Weighs in on H5N1 (The Scientist)

Other News and Interesting Reads

• Sunshine Act Still in the Shade (PharmExec Magazine)
• Transforming Business: The Silver Lining of the Sunshine Act (MDDI)
• Should FDA Cede All Standards Development To GS1? (RxTrace)
• Book Review: Phake: shining a light on substandard and falsified medicines (Securing Pharma)
• Abbott’s Humira, the 3rd-in-Class Drug That Toppled Lipitor as No. 1 (Xconomy)
• The Wireless Revolution Hits Medicine (Wall Street Journal)
• Drug Discovery Gets an Upgrade (Wall Street Journal)
• The need to do more in paediatric drug development (PM LiVE)
• Study suggests breast cancer is clutch of 10 diseases (Reuters)
• Consumers using social media for medical information, report says (LA Times)
• A Nobel Prize winner on diagnostic medical devices: they’re all apps (video) (MedCity News)