Regulatory Focus: Week in Review (8-12 October)

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.

Week in Brief

Drug manufacturing giant GlaxoSmithKline announced it will make public all of its clinical trials data, while the US Food and Drug Administration (FDA) continues to battle a nationwide outbreak of meningitis spread through unsterile steroid injections. 

Happy 50^th anniversary to the Kefauver Harris Amendments, which established FDA's authority to demand high-quality evidence and evaluate pharmaceutical products based on effectiveness.

Internationally, the European Medicines Agency (EMA) said it expects to come in slightly below projections for 2012 drug approvals and released new guidelines for developing therapies for schizophrenia and multiple sclerosis. EU-wide changes to the recently-passed pharmacovigilance legislation were also announced, calling for additional safety notifications and the closure of several potential loopholes.

Health Canada's fast-track approval pathway was meanwhile hit for having significantly higher rates of safety issues in a study published in the Archives of Internal Medicine.

Regulatory Focus Features

• Establishing Effective Device Supplier Qualifications
• Biosimilar Interchangeability Problems Pose Complex Challenge for Regulators
• As 510(k) Process Evolves, Questions Remain
• Regulatory Professionals, Top Regulators From Around the World to Converge in Seattle for 2012 RAPS

US News

• AdvaMed, Device Companies Claim FDA's 510(k) Pre-Review Guidance Lacks Objectivity (Regulatory Focus)
• St. Jude Riata Heart-Device Flaws Known for Years (WSJ)
• Study finds approval time for medical devices often lags (DOTMed)
• Analysis: When implanted medical devices go wrong, who pays? (Reuters)
• FDA Charges Ahead With MDUFA III Implementation, Despite Budget Uncertainties (The Gray Sheet)
• OIVD Becomes OIR: FDA Diagnostic Office Adds Entire Radiological Health Program (The Gray Sheet)
• FDA Won't Immediately Dispatch Investigators, 'Guns Blazing,' To Enforce UDI Regulation (The Silver Sheet)
• Allergan retracts efforts to win FDA approval to market its Lap-Band bariatric surgery to teenagers (Mass Device)

• FDA Reviewers Explain Agency's New Obesity Drug Paradigm in NEJM (Regulatory Focus)
• Data Exclusivity for Biologics at Forefront of International Trade Agreement Negotiations (Regulatory Focus)
• New FDA Guidance on Sinus Infections Focuses on Design of Clinical Trials (Regulatory Focus)
• WSJ: Johnson & Johnson Looks to Ease Drug Shortages through Shared Manufacturing Plan (Regulatory Focus)
• Group Calls for REMS-Like Conditions for Popular Hypertension Drugs (Regulatory Focus)
• The 15 best-selling drugs of 2012 (Fierce Pharma)
• Top counterfeit drug events in 2012 (FiercePharma)
• A Drug Recall That Should Frighten Us All About The FDA (Forbes)
• What Expiration? Your Drugs May Last A Long Time (Pharmalot)
• FDA And Generic Drug Quality: Turning Point, Or Precipice? (The Pink Sheet)
• FDA cites risk, but MS patients seek unproven therapy (Reuters)
• Exclusive: Questionable data propped up cancer drug Provenge (Reuters)
• Suboxone Strategy: Protecting Patients Or Profits? (Pharmalot)

• In Shift, GSK to Publish Clinical Trials Data (Regulatory Focus)
• FDA Marks Half-Century of Regulation Based on Safety, Efficacy (Regulatory Focus)
• NIH Initiative Hopes to Improve How Preclinical Testing is Reported (Regulatory Focus)
• USP Standard Aims to Reduce Medication Errors through Standardized Labeling (Regulatory Focus)
• New Chemical Testing Method to Reduce Reliance on Animal Eye Testing (Regulatory Focus)
• Proposed Study to Look at Effect of Advertising, Social Media on Prescribing Habits (Regulatory Focus)
• FDA Office of Regulatory Affairs Make-Over Blends Domestic, International Work (The Pink Sheet)
• Florida drug database intended to save lives is barely used by doctors (Tampa Bay Times)
• 'Quality-By-Design' To Ensure High-Quality Dietary Supplements (Medical News Today)
• FDA Withdraws Direct-To-Consumer Ad Guidance, As It Develops Social Media Documents (The Gray Sheet)
• FDA: Inflammation and diabetes raising red flags for tainted products (Nutra Ingredients USA)
• Facebook Posts Point Sanofi To ChangeAllegra-D Foil Packaging (The Pink Sheet Daily)
• President's Bioethics Commission Releases Report on Genomics and Privacy (PCSBI)
• Could expired drugs cut the U.S. health bill? (Reuters)
• Transparency is Here! CMS Exposes Pharmacy Prescription Profit Margins (Drug Channels)
• Future Uses of the Department of Defense Joint Pathology Center Biorepository (IOM)
• FDA Alumni Association Receives Prestigious Frances O. Kelsey Award (FDA Alumni Association)
• PETA discusses FedEx and UPS 'commitments' not to ship animals used in research (Outsourcing Pharma)

• House Democrats Take Aim at FDA, Call for Agency to Release Information (Regulatory Focus)
• As Compounding Crisis Widens, Legislators Propose Regulatory Fixes (Regulatory Focus)
• In Wake of Meningitis Outbreak, Senator Calls for New FDA Authority to Regulate (Regulatory Focus)
• Meningitis Outbreak Places Spotlight on FDA's Regulation of Compounding Pharmacies (Regulatory Focus)
• New England Compounding Center Issues Voluntary Nationwide Recall of All Products (FDA)
• FDA Statement on Fungal Meningitis Outbreak (FDA)
• Thousands Exposed to Tainted Steroid, C.D.C. Says (NYTimes)
• Scant Oversight of Drug Maker in Fatal Meningitis Outbreak (NYTimes)
• Outbreak Spurs Calls for New Controls (WSJ)
• Meningitis outbreak stirs calls for FDA pharmacy oversight (Reuters)
• Second Pharmacy Closes in Outbreak (WSJ)
• As meningitis outbreak spreads, public health funds shrink (Washington Post)
• What a Failed Vegas Sex Pill and The Meningitis Outbreak Have In Common (ProPublica)
• KV Pharma & Compounding: We Told You So (Pharmalot)
• Compounding Problems: A Conflicted Regulator (Pharmalot)
• FDA and the compounding pharmacy story (Medical Device Daily)

• Markey to FDA: Were Federal Regulators Misled by New England Compounding Center? (House)
• The 2012 Congressional Elections: What is at Stake for the Supplement Industry? (Natural Products Insider)

• J&J Settles Court Cases In Advance of Testimony by Former FDA Commissioner (Regulatory Focus)
• FTC Seeks Supreme Court's Intervention in 'Pay-for-Delay' Cases (Regulatory Focus)
• Four Former Executives Barred from Federal Programs for Unauthorized Human Testing (Regulatory Focus)
• Supreme Court Will Not Consider Preemption of Over-The-Counter Drugs (LexisNexis)
• Actelion Preemptively Sues Generic Companies Over REMS and Biostudy Product Availability Issues; Case Could be a Bellwether for Future Efforts (FDA Law Blog)
• Don't Forget FDA Prosecutorial Discretion (Drug and Device Law)
• What's the Hang-up? Apotex Sues FDA Over Compliance Failure That's Stalling ANDA Approvals (FDA Law Blog)

• The Medicines Co. abandons blood-loss drug over safety risk (Fierce Biotech)
• Recall: Device Sucks Life From Patient (MedPage Today)
• Hospira Issues A Voluntary Nationwide Recall Of One Lot Of Lactated Ringer's And 5-percent Dextrose Injection, Usp, 1000 Ml, Flexible Containers Due To Mold Contamination (PharmPro)

• Bausch & Lomb, Inc. 10/2/12
• Zimmer Manufacturing B.V. 9/19/12
• Hospira Costa Rica Ltd. 8/22/12
• First Medical Source LLC 9/26/12
• Unisis Corporation 9/7/12
• Akorn, Inc. 10/2/2012
• IsoAid, L.L.C. 8/16/12
• Analyticon Biotechnologies AG 8/10/12

• FDA Training Session Set to Focus on Clinical Trials for Rare Disease Populations (Regulatory Focus)
• FDA Advisory Committee to Assess 'Warning Fatigue' (Regulatory Focus)
• OPDP Enforcement Actions Webinar - October 29, 2012 (FDA)
• Meetings: Neurological Devices Panel of Medical Devices Advisory Committee (FDA)
• Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting (FDA)
• "Regulating the Regulators: A Conversation with Former OIRA Administrators" Public Talk (OIRA News)

EU News

• Multiple Sclerosis Guideline Calls for Adaptive Approaches Based on Risk (Regulatory Focus)
• New EMA Guideline Establishes Standards for Development of Antipsychotic Therapies (Regulatory Focus)
• EU Medical Device Regulations Will Be Adopted Before 2014 Elections, Says Commissioner Dalli (MedTech Insider)
• EU readies new moves on pharma responsibility, meds access (PharmaTimes)

• EMA Report: Approval Numbers Likely to be Lower than 2011 (Regulatory Focus)
• Countries Responsible for EU-wide Safety Monitoring Announced (Regulatory Focus)
• Amendments to EU Pharmacovigilance Legislation Call for Additional Safety Notifications (Regulatory Focus)
• European Medicines Agency publishes active substance list with lead Member State responsible for safety monitoring (EMA)

• French Regulators Launch New Prescription Drug Paradigm Aimed at Limiting Off-Label Use (Regulatory Focus)
• Sanofi Pasteur Recalls Vaccine in UK after Efficacy Concerns Raised (Regulatory Focus)
• MHRA appoints new Medical Director of Devices (MHRA)
• Europe's case against Lundbeck, Servier for blocking generic drugs will be decided next year (Med City News)

Global Regulatory News

• Australia to Launch Consultation on Development of eCTD Guidelines, Timetable (Regulatory Focus)
• Australia: Consultation: Australian regulatory guidelines for complementary medicines (ARGCM) Part A: General guidance (TGA)
• Brazil's Anvisa Addressing Drug Approval Priorities (Regulatory Focus)
• Canada: Health Canada tight-lipped on Champix suicides (The Star)
• Canada: Study: Priority Review-Approved Drugs Show Significantly More Problems Post-Approval (Regulatory Focus)
• China: China close to entering WHO-approved global vaccine market (Med City News)
• China: SFDA Official Makes Candid Comments about China's Medical Device Regulations (SFDA)
• India: DCGI to launch nationwide drive to monitor operations of medical devices sector (PharmaBiz)
• India: Pfizer to appeal India decision to revoke cancer drug patent (The Economic Times)
• Indonesia Tries To Override Pharma Patents (Pharmalot)
• ISO: ISO 10018 focuses on importance of people in quality management (ISO)
• South Africa: CEO exits as Cipla Medpro details 'gross misconduct' allegations (Fierce Pharma)
• Taiwan's FDA Says it is Aiming for 2013 Induction into PIC/S (Regulatory Focus)

Important Studies, Whitepapers and Research

• The Randomized Clinical Trial at the 50th Anniversary of the Kefauver-Harris Amendments (Quintiles)
• Lifecycle Modeling and Simulation, Part 2 (Quintiles)
• New Coating Utilizing Nanotechnology Will Allow Surgeons To Sterilize Medical Devices That Contain Biological Components (Medical news Today)

Regulatory Reads

• Can Wall Street Financial "Wizardry" Foster Drug Innovation? (Scientific American)
• The FDA is there to protect patients? Bullsh*t (MassDevice)
•  Biosimilars: The Precarious Struggle Between Cost-driven Health Care Policy and Patient-centered Care (Washington Policy Center)
• Clinical trials in social media - after the trial, patients go home and log on… (Pharma Phorum)
• Boxed Warnings and Warning Letters (EyeOnFDA)
• Managing Risk: GMPs Are Not Enough (Pharma Manufacturing)
• Data Rainbows to Medical Pots of Gold: The Physician Payment Sunshine Act (This Is Real Law)

Other News and Interesting Reads

• Worrying Trends Confronted in Prescription Drug Abuse (Scientific American)
• Have Increased Regulations Made the U.S. Less Competitive? (RegBlog)
• Is psychiatry committing 'professional suicide'? (CNN)
• Online tool to challenge "unwarranted" drug patents (PharmaTimes)
• Attention Disorder or Not, Pills to Help in School (NYTimes)
• Just Like That? Trying To Discontinue Cymbalta (Pharmalot)
• Food Sickens Millions as Company-Paid Checks Find It Safe (Bloomberg)