Regulatory Focus: Week in Review (15-19 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
The US Food and Drug Administration's (FDA) problems continue to mount as an outbreak of meningitis linked to vials of a steroid medication manufactured at a compounding pharmacy in Massachusetts continues to make ill hundreds of patients. Legislators tore into the agency this week, calling on it to release all records related to its investigations and oversight of the company-a possible preclude to a congressional hearing.
On the medical device front, FDA released three new guidance documents: two for review times under the Medical Device User Fee Act and a third pertaining to a soon-to-be-mandatory electronic submission program known as eCopy. On the pharmaceutical front, Bloomberg reported FDA is strongly considering a new paradigm for approving on a limited basis drugs with the potential to address public health needs such as obesity.
In the EU, European Commision (EC) Health Commissioner John Dalli was forced to resign due to a scandal in which he is alleged to have known about tobacco companies trading favors with government regulators. The UK's Medicines and Healthcare product Regulatory Agency (MHRA) meanwhile appointed a new head of its medical devices unit, while the European Medicines Agency (EMA) released a new guideline on acute heart failure therapies.
India, perhaps more than any other country, dominated the news cycle this week, with its regulators noting their intent to ban the introduction of branded generic medications in the country in the near future. In an unrelated move, Abbott Healthcare said it was suspending a marketing program in the country critics contended was an illegal effort to pay off doctors with items in return for prescriptions.
Regulatory Focus Features
- Perspectives on FDA Review of Medical Devices: Part 2
- Perspectives on FDA Review of Medical Devices: Part I
- Demystifying the FDA Appeals Process
- FDA Regulation of Healthcare Product Advertising on Social Media
US News
Medical Devices- FDA Releases Guidance Document on Soon-To-Be-Mandatory Device Submission Program (Regulatory Focus)
- MDUFA Guidelines on FDA Review Time and Goals Released (Regulatory Focus)
- Medical Device Group Calls for More Transparency on Proposed Naming Conventions (Regulatory Focus)
- U.S. standards organization targets medical device interoperability issues (Mass Device)
- Growing metal-on-metal hip controversy threatens to swallow more device makers (Mass Device)
- PMA Review Times Increased After User Fee Initiation, Study Affirms (The Gray Sheet)
- Exclusive: FDA to Continue Regulatory Exception for Doxil Substitute (Regulatory Focus)
- Report: FDA Considering New Approval Paradigm for Socially Beneficial Drugs (Regulatory Focus)
- DEA Classifies Bath Salt Chemical as Schedule I Drug After Oversight (Regulatory Focus)
- FDA Announces Minor Use/Minor Species (MUMS) Grant Program Request for Applications due December 7, 2012 (FDA)
- Biosimilar Podium Promotion: FDA Emphasizes Advantages Of Abbreviated Pathway (The Pink Sheet)
- Letter to Aquaculture Professionals (FDA)
- Op-Ed: How Tough Is FDA On Unapproved Drugs? (Pharmalot)
- Drug shortage led to spike in kids' infections (Reuters)
- Pharma's First Branded Facebook Ad? (ePharma Rx)
- Obesity Therapy Gap Or Regulatory Gap? REMS Not The Answer For Belviq Or GW Group (RPM Report)
- Why no FDA regulatory actions on FDAMA Section 114 violations? (CEA)
- Requiring Clinical Trial Support For Every Sec. 114 Economic Claim "Unwarranted," PhRMA Tells FDA (The Pink Sheet)
- Biosimilar Podium Promotion: FDA Emphasizes Advantages Of Abbreviated Pathway (The Pink Sheet)
- NIH launches free database of drugs associated with liver injury (NIH)
- Chronic Regulatory Compliance Issues Causing Shortages, Safety Problems (Regulatory Focus)
- FDA Office Of Regulatory Affairs Make-Over Blends Domestic, International Work (The Gray Sheet)
- FDA Global Health Subcommittee Will Focus On Regulatory Systems In Developing Countries (The Gray Sheet)
- World's Top Regulators Tackle Ethics of Pharmaceutical Innovation (Regulatory Focus)
- FDA Guidance On Peripheral Neuropathy Drugs In The Works (The Pink Sheet Daily)
- FDA Reg Science Initiative Moving Along with Academic Help (PharmTech Talk)
- Former FDA Chief on Modernizing Drug and Device Approvals (Medscape) (Video)
- Private Negotiations Over Trans-Pacific Partnership Agreement Conclude (Kaiser Global Health)
- Making industry a second language for the life sciences ivory tower (Fierce Medical Devices)
Compounding Crisis
- Congressional Investigators Ramp up Pressure on FDA over Meningitis Outbreak (Regulatory Focus)
- Regulators Scramble to Contain Compounding Crisis as Industry Scrutinized (Regulatory Focus)
- FDA Identifies Two Additional Compounded Drugs as Potentially Contaminated (Regulatory Focus)
- FDA Raids Compounding Facility Linked to Meningitis Outbreak (Regulatory Focus)
- Compounding Crisis Continues as Reports Raise Questions of Quality (Regulatory Focus)
- Meningitis outbreak "nowhere near the end": expert (Reuters)
- Meningitis Symptoms Could Be Dormant For Months (NPR)
- Mass. governor: Drug firm may have misled regulators (Modern Healthcare)
- Expert: FDA guidelines never published (CNN via YouTube)
- FDA Confirms Presence of Fungus in NECC Vials (FDA)
- Three contaminants linked to meningitis (UPI)
- Markey Asks Justice Department to Investigate Possible Controlled Substance Violations by New England Compounding Center (House)
- Compounding pharmacies need FDA oversight (Washington Post)
- Meningitis Outbreak: Restoring Confidence in the Drug Industry (ABC News)
- Meningitis deaths rise, FDA faces new questions (Reuters)
- Blumenthal Calls On DOD To Explain Contract With Compounding Pharmacy Center Linked To Deadly Meningitis Outbreak (Senate)
- California Seeks To Strengthen Regulation of Out-of-State Drugs (California Healthline)
Legislative Update
- Waxman Introduces New Bill to Require Data Collection, Monitoring by Antibiotics Industry (Regulatory Focus)
- FDA: Reps Paulsen, Eshoo call for quarterly reports on MDUFMA progress (Mass Device)
- Hidden cost: Corporations see lower tax bill when they settle with the government (Washington Post)
- Court grants plaintiffs extension in FDA whistleblower case (BioCentury)
- The End of the Road: Franck's Compounding Case is Moot (FD Law Blog)
- FDA Can Still Be A Pain to Products Plaintiffs Even When It Gets Burned (Drug and Device Law)
- Supreme Court rejects Allergan patent appeal over Sanctura (Reuters)
- "No-AG" Agreements are Anticompetitive, Says the FTC for a Second Time (FDA Law Blog)
Compliance and Safety Issues
- Stem Cell Processor, IRB Targets of Related Warning Letters from FDA (Regulatory Focus)
- Crackdown on Cosmetic Marketing Claims Expands as Avon Sent Warning Letter (Regulatory Focus)
- FDA Untitled Letter Chides Genentech Promo for Inadequate Substantiation of Claims (Regulatory Focus)
- St. Jude Medical does the unthinkable: Warns of FDA warning letter before FDA issues one (MedCity News)
- Accutron, Inc. Ultra PC% Cabinet Mount Flowmeters for Nitrous Oxide-Oxygen Sedation Systems
- Enforcement Report - Week of October 17, 2012 (FDA)
Warning Letters of the Week
- Zimmer Inc. (Medical Device)
- Acu-International Supplies, Inc. (Medical Device)
- Lime Technologies (Medical Device)
- PC Tan (Medical Device)
- Copious International, Inc. (Medical Device)
- Pulse Health, LLC (Medical Device)
- SMT-Schilling Metalltechnik GmbH (Medical Device)
- Nissei Precision Instruments (Suzhou) Co., Ltd (Medical Device)
- EPS Biotechnology Corp. (Medical Device)
- Xiantao Rayxin Medical Products Co. Ltd. (Medical Device)
- PSS World Medical Inc. (Pharmaceutical)
- Zian Medical, LLC (Pharmaceutical)
- Creation's Garden Natural Products, Inc. (Supplements / Pharmaceutical / Medical Device)
- AHN International, Inc. - d/b/a Amazing Herbs Nutraceuticals (Supplements)
- James G. Cole, Inc., dba Maxam Nutraceutics (Supplements)
- CDER Small Business Webinar 10/22 (FDA)
- Meetings: Vaccines and Related Biological Products Advisory Committee (FDA)
- Meetings: Oncologic Drugs Advisory Committee; Cancellation (FDA)
- Meetings: Endocrinologic and Metabolic Drugs Advisory Committee (FDA)
- Meetings: Cellular, Tissue and Gene Therapies Advisory Committee (FDA)
- Meetings: Nonprescription Drugs Advisory Committee (FDA)
- Meetings: Endocrinologic and Metabolic Drugs Advisory Committee (FDA)
- Unique Device Identification (UDI) Implementation Expert Workshop:Exploring the Opportunities and Challenges Associated with Capturing UDIs in Claims (Brookings)
Deals and Acquisitions
EU News
Regulation and Guidelines- EMA Releases Draft Guideline on Acute Heart Failure Therapies (Regulatory Focus)
- Auditors Hit EMA for Failing to Meet Conflict of Interest Standards (Regulatory Focus)
- EU Health Commissioner John Dalli Forced out in Wake of Fraud Probe (Regulatory Focus)
- UK's NICE Releases Guidance on Management of Crohn's Disease (Regulatory Focus)
- New Head of Devices at MHRA (Regulatory Focus)
- EU Health Commissioner Dalli's Resignation Leaves Unfinished Business For Pharma (The Pink Sheet Daily)
- Exchange of views with ECDC and EMA executive directors (ENVI)
- Use of NICE-appraised drugs continuing to vary: study (Pharma Times)
- NICE publishes first off-label summary (Pharmafile)
- New EU cosmetics regulation in place next year: A closer look (Cosmetics Design Europe)
- MHRA looking to appoint five members to the Independent Scientific Advisory Committee (ISAC) (MHRA)
Global Regulatory News
- Australia's Overhaul of OTC Guidelines Attracts Industry Comments, Proposed Revisions (Regulatory Focus)
- Australia - TGA Calls for Biologics Applications in Advance of Deadline (Regulatory Focus)
- Australia - Australia launches clinical trials website to boost recruitment (Pharma Times)
- China Classifies, Reclassifies Dozens of Medical Devices After Review (Regulatory Focus)
- China - SFDA Issues Guiding Opinions on Electronic Supervision of Drugs (SFDA)
- ICH - Details of the discussions from the ICH GCG in June 2012 (ICH)
- ICH - Updated MedDRA Guidance available for MedDRA version 15.1 (ICH)
- India - Under Fire, Abbott Suspends Marketing Program in India (Regulatory Focus)
- India - Indian pharma regulations should not change to suit others, says the Government (In-Pharma Technologist)
- India's CDSCO Orders Local Authorities to Adhere to Drug Regulations (Regulatory Focus)
- India - Pharma industry frowns at Govt's move on grant of product licenses in generic names (PharmaBiz)
- India - India plans ban on branded generics (PharmaFile)
- India - Recycle, reduce, reuse: Americans' heart devices reimplanted safely in India (MedCity News)
- India - India Russia in process of liberalising new drugs registration (Economic Times of India)
- India - India's clinical trials hit by ethical concerns (PharmaFile)
- India - New Drug Policy may not be ready by Nov end as DOP needs revised list of NLEM (PharmaBiz)
- Indonesia - Indonesia issues compulsory licences against seven HIV, hepatitis drugs (PharmAfrica)
- Ireland - New Rules to Voluntarily Restrict Prescription Drug and Device Marketing in Ireland (Regulatory Focus)
- Japan's PMDA Reorganizes Biologics Offices (Regulatory Focus)
- Tanzania - TPI dissociates itself from fake ARVs (PharmAfrica)
Important Studies, Whitepapers and Research
- The deadly world of falsified and substandard medicine (AEI)
- A Blueprint for Clinical and Commercial Convergence (Quintiles)
- Contract Support and Technical Service Providers Expected to Play a Growing Role in Drug Development (Tufts CSDD
- Experts Say, Popular Over-The-counter Drugs Not Much Effective (MedIndia)
- cGMP Compliance is Pharma's Top Manufacturing Goal, Preliminary Survey Results Suggest (PharmaManufacturing)
- Chat rooms used to check drug safety (PharmaFile)
Regulatory Reads
- In Cancer Care, Cost Matters (NY Times)
- Whistleblower Case Highlights FDA Confidentiality Concerns (PharmExec)
- Bad Pharma by Ben Goldacre - review (The Guardian)
- Time to Change FDA's Discriminatory Blood Donation Policy (Bioethics Forum)
- Wanted: Experienced Regulatory Affairs Personnel (Cutting Edge Info)
- Reform, Regulation, and Pharmaceuticals - The Kefauver-Harris Amendments at 50 (NEJM)
- Are Doctors Too Wary of Drug Companies? (NY Times)
- Who Ya Gonna Call? (Eye on FDA)
- An Engineer Takes on the Medical Device Regulatory Process, Part II (MDDI)
- Don't confuse hard science with bad pharma (AEI)
- How to Handle an FDA-483 Observation When You Don't Agree (PharmTech Talk)