Regulatory Focus: Week in Review (23-27 July)

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: [16-20 July] [9-13 July] [18-22 June] [11-15 June] [4-8 June

Top News Items

Regulatory Moratorium Bill Passes House
The US House of Representatives passed a bill that would freeze many regulations, including those introduced by the US Food and Drug Administration (FDA), until unemployment falls to pre-recession levels.

FDA Releases Draft Guidance on 510(k) Submissions
The US Food and Drug Administration (FDA) has released a new draft guidance for its staff members and industry instructing them on how to assess the safety risks of small-bore connectors submitted through a 510(k) application.

FDA Fires Back at Legislative Critics, Blames Manufacturers for Drug Shortages
The US Food and Drug Administration (FDA) is seeking to distance itself from a June 2012 report by the House Oversight Committee claiming the regulatory agency is the root cause of drug shortages currently plaguing dozens of pharmaceutical products.

European Trade Regulators Charge Companies for 'Pay-for-Delay' Agreements
If industry practitioners of so-called pay-for-delay settlements are worried about the climate for the legal agreements in the US after a recent court ruling against the measures, they should be just as concerned about European regulators, reports Reuters and The Financial Times.

NICE to Assume Review of High-cost Orphan Drug Products
The UK's national health technology assessment (HTA) body, the National Institutes for Health and Clinical Excellence (NICE), is set to start assessing what it refers to as the "very high cost of drugs for people who suffer with rare conditions" under the new Health and Social Care Act of 2012.

Regulatory Focus Features

[Editor's Note: During the Month of July 2012, all Regulatory Focus Articles Are Accessible at No Charge]

• Op-ed: New RAPS Research on the Regulatory Profession
• How Safe Are Biosimilars? Implications of FDA and EMA Guidances and European Experience since 2006 (Part 2)
• East Africa Leads Medicine Registration Harmonization Thrust
• Voluntary Harmonization Process for Multinational Clinical Trials in the EU
• Perspective: Advancing Breakthrough Therapies for Patients
• Approval of Jakafi (ruxolitinib) Based on a Home-Grown, Patient-Reported Outcome Instrument: A Case Study
• Changes Coming to FDA Quality System Requirements for Prefilled Injection Devices
• Biosimilar Medicinal Products: Innovation in Regulatory Review and Approval
• Can Rodent Carcinogenicity Testing Be Eliminated?

US News

Medical Devices

• FDA Releases Draft Guidance on 510(k) Submissions (Regulatory Focus)
• Report Highlights Potential Impact of Spectrum Changes on Medical Device Innovation (Regulatory Focus)
• Study: Security, Software Reporting Methods In Need of Improvement (Regulatory Focus)
• 'Generic' medical devices could cut into name-brand profits (The Republic)
• ODAC to consider clinical usefulness of kidney cancer imaging tests (BioCentury)
• Need for FDA Changes Called 'Dire' (MDDI Online)
• FDA Continues to Allow Sale of Unapproved Medical Device (Public Citizen)
• Medical Device Security Info Lacking (Gov Info Security)

Pharmaceutical and Biologics

• FDA Fires Back at Legislative Critics, Blames Manufacturers for Drug Shortages (Regulatory Focus)
• Legislators: Abusive Practices Leading to Drug Shortages, Massive Markups (Regulatory Focus)
• California County to Pharmaceutical Manufacturers: Pay Up (Regulatory Focus)
• FDA Backs HIV Prevention Drug In Letter Denying Citizen Petition (Regulatory Focus)
• Capping Busy Week, FDA Approves Breast Cancer, Multiple Myeloma Drugs (Regulatory Focus)
• US Regulators Give Final Shot to Owners of Unapproved Drug Products (Regulatory Focus)
• FDA approves Tudorza Pressair to treat chronic obstructive pulmonary disease (FDA)
• 28 Drugs Facing FDA Approval in 2012-2013 (The Street)
• Biosimilars Development Should Target "Residual Uncertainty," FDA Says (The Pink Sheet)
• How Fake Cancer Drugs Entered U.S. (WSJ)
• Anemia drugs made billions, but at what cost? (The Washington Post)
• GA Switching to Single-Drug Method for Executions (PharmPro)
• Group Asks FDA for Painkiller Guidelines (WSJ)
• Some paramedics turn to expired drugs due to shortages (KATU)
• VA Innovation Initiative project aims for fewer adverse drug events (Fierce Health IT)

Other US News

• NIH Program Partners With FDA to Develop Regulatory Tools (Regulatory Focus)
• Regulators, Contractor in Spat Over Accidental Release of Documents (Regulatory Focus)
• PCORI: Industry Likely Skewing Trial Outcomes to Detriment of Patients, Regulators (Regulatory Focus)
• FDA's 'Bad Ad' Program Marks Second Year of Operation (Regulatory Focus)
• Study: Pediatric Clinical Trials Remain Scarce (Regulatory Focus)
• Whooping Cough: Worst Year For Pertussis In 5 Decades, CDC Says (The Huffington Post)
• Google, Yahoo and Microsoft join campaign to tackle illegal online pharmacies (PM Live)
• Scientist Behind FDA Flap Sued Prior Employers (WSJ)

Legislative Update

• Regulatory Moratorium Bill Passes House (Regulatory Focus)
• Major Regulatory Changes Proposed in House Bill (Regulatory Focus)
• Proposed Legislation Overhauls Regulatory Environment for Tamper-resistant Opioids (Regulatory Focus)
• New FDA Law Paves Way For mHealth Regulations (Information Week)
• House budget would keep NIH flat (BioCentury)
• Frenzy over sequester hits Capitol Hill (Politico)
• Domestic programs gird for sequester (Politico)
• GOP fears shutdown showdown (Politico)
• Bayer Whistleblower Lawsuit Is Dismissed (Pharmalot)

The Courts

• Court Orders FDA to Release Thousands of Documents on Surveillance Program (Regulatory Focus)
• FDA: Challenge to Enforcement Discretion Without Standing, Merit (Regulatory Focus)
• U.S. appeals court reconsiders Myriad gene patent ruling (Reuters)
• J&J Appeals $1.2 Billion Arkansas Risperdal Ruling (Bloomberg)
• US Judge Upholds Claims in Pfizer's Lyrica Patents (Nasdaq)
• Bard loses 1st of transvaginal mesh patient injury lawsuits (Mass Device)
• Court to Decide Whether Genes Can Be Patented (WSJ)

Compliance and Safety Issues

• Untitled Letter Cites Company for Risk Omissions, Insufficient Trial Strength (Regulatory Focus)
• Warning Letter: Franck's Lab Inc., d.b.a. Franck's Compounding Lab 7/9/12 (FDA)
• Warning Letter: Sanofi Pasteur Limited - Cannaught Campus 7/12/12 (FDA)
• Warning Letter: Sanofi Pasteur SA 7/12/12 (FDA)      
• Enforcement Report - Week of July 25, 2012 (FDA)
• FDA ravages Sanofi vaccine sterility process in warning letter (Fierce Pharma Manufacturing)
• FDA Drug Safety Communication: Seizure risk for multiple sclerosis patients who take Ampyra (dalfampridine) (FDA)

Workshops & Meetings

• US Regulators, Defense Officials to Converge for Meeting on Blood Product (Regulatory Focus)
• Cardiovascular and Renal Drugs Advisory Committee (FDA)
• Ophthalmic Devices Panel of the Medical Devices Advisory Committee (FDA)
• Workshops: Food and Drug Administration Pediatric Medical Devices (FDA)
• Unique Device Identification (UDI) Implementation Work Group Kick-Off (Brookings)

 
Deals, Acquisitions and Business

• Where Is Everyone? Biotech's Dwindling Number of Venture Firms (Life Sci VC)

EU News

Regulation and Guidance

• ICH guideline E3 - questions and answers (R1) (EMA)
• ICH guideline Q4B: Annex 13 to note for evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on bulk density and tapped density of powders - general chapter (EMA)
• Recommendation to marketing authorisation holders, highlighting the need to ensure compliance with 3Rs methods described in the European Pharmacopoeia (EMA)
• Guidance on centrally authorised products requiring a notification of a change for update of annexes (EMA)
• VICH GL36(R): Studies to evaluate the safety of residues of veterinary drugs in human food: general approach to establish a microbiological ADI (EMA)

EMA Information

• EMA Releases Additional Pharmacovigilance Guidelines, Announces Closure of Committee (Regulatory Focus)
• EU Guidance Provides 'Assessment Strategy' For Environmental Testing of Veterinary Drugs (Regulatory Focus)
• Concept paper for revision of the guideline on harmonising the approach to causality assessment for adverse reactions to veterinary medicinal products (EMA)
• Revised concept paper on the need for revision of the position on the replacement of animal studies by in vitro models (EMA)
• European Medicines Agency recommends limiting long-term use of calcitonin medicines (EMA)
• Registration open for workshop on access to clinical trial data and transparency (EMA)
• European Medicines Agency publishes sources for orphan-disease prevalence data (EMA)
• More GMP Inspections by EMA due to Increasing Quality Issues (European Compliance Academy)

Other EU News

• European Trade Regulators Charge Companies for 'Pay-for-Delay' Agreements (Regulatory Focus)
• EMA Issues Warning on Osteoporosis Medicines (Regulatory Focus)
• CHMP Recommends EU's First Gene Therapy Product (Regulatory Focus)
• Continuing Transparency Push, EMA to Make all Meeting Minutes Public (Regulatory Focus)
• UK: New Anti-clotting Drug Cleared for NHS Use (Regulatory Focus)
• NICE to Assume Review of High-cost Orphan Drug Products (Regulatory Focus)
• EU proposals on medical device UDIs due in September (Securing Pharma)
• UK: NICE Evidence Summaries Offer A Possible Cure For "NICE Blight" (The Pink Sheet Daily)
• UK: Physiotherapists and podiatrists set to gain prescribing powers (DOH)

Global Regulatory News

• Global pharmaceutical industry calls for broad-based cooperation to fight online sales of counterfeit medicines around the world (PhRMA)
• New International Standard Assures Consistent and Proper Labelling of Medical Devices (MedTechInsider)
• Africa: AIDS: Drug Resistance Growing in Parts of Africa, a Study Says (NYTimes)
• Australia: Transparency reforms on track at the TGA (TGA)
• Australia: Annual charges for manufacturing licences (TGA)
• Australia: Annual charges for therapeutic goods (TGA)
• Brazilian Regulators Go On Strike (Regulatory Focus)
• India: Natco Seeks More Compulsory Licenses In India (Pharmalot)
• India: Government may ease FDI norms in pharmaceutical industry (The Economic Times)
• India: Clinical Trial Deaths In India Dropped, But… (Pharmalot)
• Korea: KFDA signs MOU with NA-DFC (KFDA)
• Russia: Top Russian Regulator: We Don't Have Authority to Stop Counterfeiters (Regulatory Focus)
• WHO Issues Guidance on PrEP Products to Minimize HIV Transmission (Regulatory Focus)

Important Studies, Whitepapers and Research

• Sport Products Focus of MHRA, Academic Investigations (Regulatory Focus)
• Serious side effects more likely in new cancer drugs (Reuters)
• United States Private-Sector Physicians and Pharmaceutical Contract Research: A Qualitative Study (PLoS Medicine)
• Patient groups are influencing govt policy, study finds (Pharma Times)

Regulatory Reads

• The ugly underbelly (BioCentury)
• FDASIA, Part 1: The "UFAs" (Ask CATO)
• The Op-Ed: Institutions Need Conflict Committees (Pharmalot)
• Heavy Metals In Your Drugs? USP's Zaidi Explains (Pharmalot)
• More FDA Control Does Not Mean More Safety (CEI)
• FDA: Where All The Drugs Are Above Average (RPM Report)
• White House Now Not Sure it is Interested at All in Public's Ideas for Strengthening Existing Rules (Center for Progressive Reform)
• Fewer Approvals and Filings Sully FDA Offensive (GEN)

Other News and Interesting Reads

• Who Is Popping All Those Pills? (Forbes)
• Why Can't Medicine Seem to Fix Simple Mistakes? (ProPublica)