Regulatory Focus: Week in Review (30 April - 4 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: [23-27 April] [16-20 April] [9-13 April] [2-6 April] [26-30 March]

Top News Items

France: New Agency to Soon Replace AFSSAPS (Regulatory Focus)
France has created a new agency, the National Agency for the Safety of Medicines and Health Products (MSNA), to replace its current regulatory agency, Afssaps.

FDA Announces Additional Restrictions on Disqualified Clinical Investigators (Regulatory Focus)
The US Food and Drug Administration (FDA) is announcing changes to its rules governing how clinical investigators are disqualified, vastly expanding the scope of the disqualification.

EU Looks to Tighten Medical Device Safety With Implant Registry (Regulatory Focus)
The European Parliament is actively looking to pass legislation that would make it easier for regulatory authorities to track both medical devices and patients implanted with medical devices, reports Fierce Medical Devices.

AHRQ Looking to Establish Registry of Patient Registries (Regulatory Focus)
The US Agency for Healthcare Research and Quality (AHRQ), the federal agency charged with improving how healthcare dollars are spent, is announcing its intention to launch a registry of patient registries modeled after of its ClinicalTrials.gov website.

Regulatory Focus Features

• Demystifying Electronic Data Standards for Clinical and Nonclinical Studies (Regulatory Focus) (Subscription)
• Regulatory Environment Changes Affect REMS (Regulatory Focus) (Subscription)
• Bloodletting and Malariatherapy: Treatment Methods of the Past (Regulatory Focus) (Subscription)
• Outstanding Contributions Deserve Outstanding Recognition (Regulatory Focus) (Free)

US News

FDA Information: Medical Devices

• CMS Coverage Decision Based on FDA Parallel Review Program (Regulatory Focus)
• FDA permits marketing of a new device for abdominal surgery (FDA)
• Devices Gain Ground On Pharmacists In Switch Paradigm Talk (The Pink Sheet)

FDA Information: Pharmaceutical and Biologics

• FDA Looking to Develop Further REMS Guidance, Release Issue Paper (Regulatory Focus)
• New Biologic Sterility Regulation Issued by FDA (Regulatory Focus)
• Report: FDA Meeting Review Goals Under PDUFA (Regulatory Focus)
• CBER Wants Better Vaccine Safety, Identify Adverse Events (Regulatory Focus)
• FDA's Chief Scientist Reveals Planned Animal Rule Revisions, Regulatory Science Initiatives (Regulatory Focus)
• CDER Provides Guidance to FDA Staff on How to Expedite Review of ANDA Supplements (Regulatory Focus)
• J&J Antibiotic Approved Via 'Animal Rule' Pathway (Regulatory Focus)
• A Short Tutorial on REMS: The FDA Perspective (Medscape News)
• Levaquin Approval For Plague Carries Just One Postmarketing Requirement (The Pink Sheet)
• FDA approves Votrient for advanced soft tissue sarcoma (FDA)
• FDA approves Afinitor for non-cancerous kidney tumors caused by rare genetic disease (FDA)
• FDA approves Stendra for erectile dysfunction (FDA)
• FDA approves new orphan drug to treat a form of Gaucher disease (FDA)

FDA Information: Other News

• FDA Announces Additional Restrictions on Disqualified Clinical Investigators (Regulatory Focus)
• FDA Disputes Study Findings, Goes After Some Clinical Trial Sponsors (Regulatory Focus)
• Report: FDA Increasingly Playing Key Role in Global Health (Regulatory Focus)
• Have Blog, Will Travel: FDA Employees Shed Insight on Agency's Activities, Goals (Regulatory Focus)
• Hamburg Touts FDA's Promotion of a 'Robust Field of Regulatory Science' in Speech (Regulatory Focus)
• FDA Watch: Andrew von Eschenbach says that the Food and Drug Administration needs big changes. (National Journal)
• FDA Regulation of Cosmetics Nears Despite Industry Objections (ABC News)

Other US News

• AHRQ Looking to Establish Registry of Patient Registries (Regulatory Focus)
• New US Bioeconomy Blueprint Addresses Regulatory Hurdles for Drugs, Medical Devices (Regulatory Focus)
• Obama Signs Order Promoting International Regulatory Cooperation (Regulatory Focus)
• IOM Issues Report on Studying Safety of Approved Drugs (Regulatory Focus)
• US Agency Releases Assessment Report on Nanotechnology, Calls for Refined Regulatory Approach (Regulatory Focus)
• Bill would bolster state's ability to monitor meth manufacturers (The Oklahoma Daily)
• Wounded Warriors Face New Enemy: Overmedication (NPR)
• Hospital seeing more babies born exposed to prescription drugs (CNN)
• PCORI Will Fund 50 Pilot Project Grants To Bolster Research Foundation (The Pink Sheet)
• Secret Briefing Helped Sway H5N1 Flu Papers Decision (Science Magazine)
• Government Considers Overdose Antidote, Naloxone, to Fight Prescription Drug Misuse (Time)

Legislative Update

• FDA Receives Small Funding Boost In Senate Appropriations Bill (Regulatory Focus)
• Legislation Introduced to Require 'Plain Writing' for all Regulations (Regulatory Focus)
• For high-tech lifesavers, an urgent push in Congress (The Star Tribune)
• Resurgence of Pharma Lobbying Spending  (Pharma Marketing)
• Biologics Data Protection In Trade Agreements Becoming Key Focus For PhRMA (The Pink Sheet Daily)
• Even If Bills to Hasten Drug Approvals Pass, Investments May Remain Dry Longer than Stakeholders Claim (GEN)

The Courts

• Bristol-Myers Gets Subpoena For Bribes Probe (Pharmalot)
• Merck defeats Mylan in Zetia-Vytorin patent lawsuits (PMLive)
• Pfizer Settles B.Y.U. Lawsuit Over Development of Celebrex (New York Times)

Compliance and Safety Issues

• FDA Warning Letter Cites Company for Breaking HCT/P Regulations (Regulatory Focus)
• FDA Sends out Warning Letters to Supplement Manufacturers (Regulatory Focus)
• Six Dietary Supplement Manufacturers Cited by FDA for Promoting Unproven Claims, cGMP Violations (Regulatory Focus)
• Regulatory, compliance issues continue to weigh down Invacare (Med City News)
• Diabetes: DOJ investigates Shires' DermaGraft marketing (Mass Device)
• New Riata data from St. Jude shows increased lead problems (Mass Device)
• McKesson Corp. Pays U.S. More Than $190 Million to Resolve False Claims Act Allegations (DOJ)
• Recent FDA Warning Letters (FDA)

Workshops & Meetings

• The Role of Telehealth in an Evolving Health Care Environment Workshop (IOM)
• Delivery of Benefits from Medicines, Supplements Improved by Product Performance Standards Compliance and Safety Issues (USP)
• Public Meeting of the Presidential Commission for the Study of Bioethical Issues (DHHS)

Deals and Acquisitions

• Watson Pharmaceuticals to Acquire Actavis for $5.6 Billion (Biopharm International)

EU News

[Editor's Note: EMA was closed 1 May and did not release any guidance 1-3 May]

Regulation and Guidance

• EMA Releases Paper on Advanced Therapies to Assist Sponsors (Regulatory Focus)
• EC: SCENIHR Issues Memorandum on Europe's Scientific Risk Assessment Process (Regulatory Focus)

EMA Information

• EU Looks to Tighten Medical Device Safety With Implant Registry (Regulatory Focus)
• Industry Pans EU Plan to Implement Medical Device Registry (Regulatory Focus)
• EMA Expands Access to Electronic Submission Gateway Pilot to Include Veterinary Products (Regulatory Focus)
• EMA Announces Temporary Office Closure, Website Maintenance (Regulatory Focus)
• Report: EU Anti-counterfeiting Directive Attracting Industry Praise, Scorn (Regulatory Focus)
• European Commission Demands Bulgaria 'Correctly Implement' Regulatory Legislation (Regulatory Focus)
• European Medicines Agency approves 100th herbal community monograph (EMA)
• Memorandum on the use of the scientific literature for human health risk assessment purposes - weighing of evidence and expression of uncertainty  (SCENIHR)
• European Medicines Agency publishes new versions of controlled vocabularies used to comply with Article 57 (2) requirements on submission of information on medicines (EMA)

Other EU News

• EFPIA: With EDQM Absent, EFPIA Launching Own Anti-Counterfeit Strategy (Regulatory Focus)
• France: New French Regulatory Agency Announces Transition of Leadership (Regulatory Focus)
• France: New Agency to Soon Replace AFSSAPS (Regulatory Focus)
• Germany: IQWiG Finds Melanoma Drug Extends Life (Regulatory Focus)
• UK: Two Breast Cancer Drugs not Recommended by NICE in Latest Draft Guidance (Regulatory Focus)
• UK: New ABPI team to forge closer link between industry and NHS (Pharma Times)
• UK: Reduced fee for Decentralised Procedure applications where the UK is the Reference Member State (MHRA)
• UK: Drug company attacks Nice for rejecting new lupus treatment (The Guardian)
• UK: MHRA makes its largest ever confiscation order of £14.4 million against fake medicines trader (MHRA)
• UK: New ABPI partnership team should be NHS 'bridge-head' for industry (PMLive)
• UK: ABHI clamps down on advertising malpractice (Pharma Times)
• UK: Executive perspectives: Sir Andrew Dillon (part 1) (Pharma Phorum)
• UK: Executive perspectives: Sir Andrew Dillon (part 2) (Pharma Phorum)

Meetings and Workshops

• European Medicines Agency-European Federation of Pharmaceutical Industries and Associations modelling and simulation workshop (EMA)
• EMA workshop on Pharmacogenomics: from science to clinical care (EMA)
• Workshop on Health-Related Quality of Life (HRQoL) in oncology (EMA)

Global Regulatory News

• AHWP: Workshop Program and Meeting Agenda (draft) for the 15th AHWP TC Meeting in Manila, Philippines (5-7 June 2012) (AHWP)
• Asian Harmonization Working Party Joins ISO, IMDRF (Regulatory Focus)
• Brazil: New Rules For Excipients Published (Regulatory Focus)
• Brazil: New Board Procedures Established For Oral Arguments (Regulatory Focus)
• Canada Accelerating Process by Which Drugs Undergo Prescription-to-OTC Switch (Regulatory Focus)
• China: Deadlines Established For Opthalmic GMP Implementation (Regulatory Focus)
• Health Canada Looking to Transition all Submissions to eCTD Format (Regulatory Focus)
• India: DoP says competition doesn't always lead to cheaper drugs; raises concern among industry
• India: India presses Japan over pharma trade barriers (India)
• ISO Releases New Device Standard for Toothbrushes (Regulatory Focus)
• TGA Announces New Head of Agency (Regulatory Focus)

Important Studies, Whitepapers and Research

• Study: Many Clinical Trials Small, of Poor Quality (Regulatory Focus)
• Avastin and Lucentis equal for treating wet AMD - NIH study (Pharma Times)
• Open-data project aims to ease the way for genomic research (Nature)
• High-impact sports reduce life span of artificial hips (Fierce Medical Devices)
• Parents With Poor Math Skills may Make Mistakes When Measuring Medications (MedIndia)
• Taking advantage of the Medtech market potential in India: success will hinge on operating model innovation (PwC)
• Does Conflict of Interest Disclosure Worsen Bias? (PLoS Medicine)
• Facing the Reality of Drug-Resistant Tuberculosis: Challenges and Potential Solutions in India - Summary of a Joint Workshop by the Institute of Medicine, the Indian National Science Academy, and the Indian Council of Medical Research (IOM)

Regulatory Reads

• Gold mine or dumpster dive? A closer look at adverse event reports (Science-based Medicine)
• Four Medical Implants That Escaped FDA Scrutiny (ProPublica)
• Why the electronic medical record needs to be viewed as a medical device (Mass Device)
• AHA: Tired? It might be alarm fatigue (Cardiovascular Business)
• Professional regulation - a DIY job? (InPharm)
• In Search of Slowness: The Effect of OMB on the Rulemaking Process (RegBlog)

Other News and Interesting Reads

• After Crackdown on Counterfeits, a 'River of Pills' (Regulatory Focus)
• WorkiLeaks: How to Be a Workplace Leaker Without Getting Caught (Wired)
• J&J's New Path Forward - An Interview With Alex Gorsky (The Pink Sheet)