Regulatory Reconnaissance (17 April 2013)

Good morning and welcome to another edition of Regulatory Reconnaissance.

In the US, legislators slammed FDA Commissioner Margaret Hamburg during yesterday's compounding hearing, a new legislative report claims FDA waivered in its attempt to shut down a dangerous compounding facility, FDA loosens restrictions on Vivus' weight-loss drug Qsymia, Allergan's NDA for Levadex is rejected based on quality concerns, regulators flag concerns with an Endo Pharma NDA, J&J's earning rebound based on regulatory improvements, Lilly's diabetes drug dulaglutide performs well in Ph III trials, Jeffery Shuren shows off a new adverse reporting app for devices, a study shows the majority of all recalls involve dietary supplements, CMS issues a new protocol for fraud self-disclosure, and a new court case casts doubts on what constitutes labeling.

Abroad, a massive legal case regarding faulty breast implants starts in France, China's FDA wants more staff and authority for its provincial staff, EU stakeholders advance a drug verification scheme, EMA studies the use of antibiotics in animals, Spain's legal challenges throw a wrench in attempts to make a unified patent system in the EU, India to issue first written confirmation certificates to API exporters to EU, a scholar highlights still more problems with India's patent ruling, and France announces it will look into DEC-containing products.

Plus: A watchdog group says too many labs still have strains of a new-defunct cattle disease, raising the risk of it being re-introduced and decimating animal populations.

Five in Focus

1. FDA chief grilled on meningitis outbreak as new documents emerge (Reuters) (E&C Committee) (The Hill) (LATimes) (The Pink Sheet) (SCRIP Intelligence) (FDA News) (Modern Healthcare) (Washington Post) (AP) (Bloomberg) (NYTimes)
2. Allergan's Migraine Drug Inhaler Levadex Rejected due to Quality Issues (Bloomberg) (Reuters) (NYTimes) (Fierce Pharma Manufacturing) (SCRIP Intelligence) (The Pharma Letter) (FDA News) (The Pink Sheet)
3. FDA Loosens Restrictions on Vivus Weight-Loss Pill (Reuters) (The Street) (SCRIP Intelligence) (BioCentury) (The Pharma Letter)
4. Adverse Event Reporting? FDA Has An App for That (MDDI)
5. Faulty breast implant trial to start in France (The Telgraph) (AP)

US

Pharmaceuticals/Biotechnology

• FDA chief grilled on meningitis outbreak as new documents emerge (Reuters) (E&C Committee) (The Hill) (LATimes) (The Pink Sheet) (SCRIP Intelligence) (FDA News) (Modern Healthcare) (Washington Post) (AP) (Bloomberg) (NYTimes)
• Congressional report says FDA faltered in deadly meningitis outbreak (E&C Committee) (Report) (NBC) (Pharmalot) (CBS) (USA Today)
• Purdue Pharma Gets a New REMS That Removes ANDA Holders From the Timetable for Submission of Assessments (FDA)
• The Science of Abuse-Deterrence - Progress Toward Creating Safer Opioids (FDA Voice)
• US API Imports for Clinical Trials Now Require Effective IND, Expert Says (Outsourcing Pharma)
• Allergan's Migraine Drug Inhaler Levadex Rejected due to Quality Issues (Bloomberg) (Reuters) (NYTimes) (Fierce Pharma Manufacturing) (SCRIP Intelligence) (The Pharma Letter) (FDA News) (The Pink Sheet)
• Endo's Testosterone REMS, Revised Dosing Don't Solve FDA Concerns (Reuters) (The Pink Sheet) ($) (Law 360)
• FDA Loosens Restrictions on Vivus Weight-Loss Pill (Reuters) (The Street) (SCRIP Intelligence) (BioCentury) (The Pharma Letter)
• FTC Chairwoman Edith Ramirez Reiterate's Agency's Focus on Preventing Pay-for-Delay Agreements (FTC) (Testimony)
• State of Quality and Compliance in the Biopharmaceutical Industry: Have FDA initiatives improved manufacturing quality? (BioPharm International)
• Irish biopharma firm secures FDA orphan drug status for gene therapy product (Silicone Republic)
• Eisai Appoints New Trials Exec To Help Stop Late-Stage Failures (Outsourcing Pharma)
• Hospira again names an exec to get manufacturing in order (Fierce Pharma Manufacturing)
• Fort Washington plant still on hold, but J&J says more Tylenol and Motrin on shelves (Philly Pharma) (WSJ)
• Top Republicans Praise FDA Ruling on Generic Painkillers (BG Daily News)
• What Should the FDA Do When Drug Tests Are Tainted? (ProPublica)
• No Substitute: When a Generic Drug Isn't What it Seems (ProPublica)
• Takeda's Actos Diabetes Drug Tied to Cancer, Jury Is Told (Bloomberg)
• Analysis of FDA Report Shows 'Startlingly High Percentages of Supermarket Meat Containing Antibiotic-Resistant Bacteria,' Group Claims (Farm Futures)
• Lilly's diabetes drug dulaglutide shines again in Phase III (Pharma Times) (Reuters) (BioCentury) (RTT)
• Nanotech-based immunotherapy gets FDA nod to start clinical trials (BioSpectrum)
• Almirall/Forest's COPD inhaler close to filing (Pharma Times)
• Plan B Should Be Over-The-Counter, Medical Groups Say (Law 360) ($)
• Actavis to sell generic Yaz birth control after ruling (Reuters)
• Novartis Didn't Properly Test Hypertension Drugs, Suit Says (Law 360) ($)
• Almirall, Forest report Phase III COPD data for combo (BioCentury) (The Pharma Letter) ($)
• Sargent Pharmaceuticals, Teva, Hospira and Baxter all Discontinuing Ondansetron Injections After Issuing Safety Communications (FDA)
• Sandoz Discontinuing Triamclinolone Hexacetonide (Aristospan) (FDA)
• FDA Confirms Suspension of Approval of Enroflox 100 for Cattle (FDA)
• OIG Report on Pharmaceutical Compounding (OIG) (10 April) (FDA Law Blog)

Medical Devices

• Adverse Event Reporting? FDA Has An App for That (MDDI)
• Jury Sides With DePuy At 2nd Hip Implant Trial (Reuters) (Law 360)
• Intuitive 'Watered Down' Robot Training, Lawyer Says (Bloomberg)
• FDA OKs Carticept's next-gen computer-controlled injection system (Mass Device)
• J&J Jury Urged to Award $5 Million for Failed Metal Hip (Bloomberg)
• J&J, Dozen Other Cos. Sued Over Fluid Delivery Patent (Law 360)

Assorted

• Feds issue updated protocol on fraud self-disclosure (Modern Healthcare)
• When is a Website Considered Labeling? (FDA Law Blog)
• Public Citizen to Secretary of HHS: Suspend Enrollment in Baby Trials, Release Details of Ongoing and Earlier Experiments (Public Citizen)
• Majority of Drug Recalls in US Over Last Ten Years Involved Dietary Supplements (MedIndia) (Natural Products Insider) (Think Progress)
• USPLabs Throws in the Towel on DMAA (Natural Products Insider)
• Making Health and Health Care Equal for All (FDA)
• Precision for Medicine, Inc. Appoints Former FDA Advisor Vicki Seyfert-Margolis as Chief of Science and Strategy (Business Wire)

Government and Budget

• Dems take on pharmaceutical industry in push for Medicare cuts (The Hill)
• Initial Tests Show Ricin Poison in Letter to U.S. Senator (Bloomberg)

Upcoming Meetings and Events

• 15 April 2013: Supreme Court Hears Case Between the Association for Molecular Pathology v. Myriad Genetics, Inc on Whether Genes May be Patented (SCOTUS Blog)
• 17 April 2013: Cellular, Tissue and Gene Therapies Advisory Committee Meeting (FDA)
• 17 April 2013: Pulmonary-Allergy Drugs Advisory Committee Meeting Announcement (FDA)
• 18 April 2013: Joint Meeting of the Advisory Committee for Reproductive Health Drugs and Drug Safety and Risk Management Advisory Committee (FDA)
• 18 April 2013: A Financial Review of the Department of Health and Human Services and Its FY 2014 Budget (E&C)
• 19 April 2013: Senate Appropriations Subcommittee on Agriculture and FDA to Hold Hearing, Hamburg Will Testify (Appropriations)
• 26 April 2013: Senate Appropriations Committee to Markup FDA Bill (Appropriations)
• Other Upcoming FDA Advisory Committee Meetings and Topics (Eye on FDA)

International

• Faulty breast implant trial to start in France (The Telgraph) (AP)
• CFDA Aims For Bigger Staff, More Power For Provinces As Cabinet-Level Agency (PharmAsia News)
•  EU stakeholders move ahead with drug verification scheme (Securing Industry)
• Use of antibiotics in animals - European Medicines Agency to give advice to European Commission on public- and animal-health impact (EMA)
• Eisai Receives Manufacturing and Marketing Authorization for Vascular Embolization Device DC Bead in Japan (Eisai)
• Spain's continued fight could make EU patent uncertain until 2015 (SCRIP Intelligence)
• Australian Judge queries fairness of Vioxx settlement (The Brisbane Times)
• DCGI to issue first WC certificates to API exporters to EU based on accreditations (PharmaBiz)
• Public consultation of the Policy for the HTA Core Model® and core HTA information (EU Net HTA)
• No reason to cheer India drug verdict (AEI)
• France Announces Probe Into Safety of Diethylstilbestrol (DES) (ANSM)

General Regulatory and Interesting Articles

• Too many labs still keep dangerous cattle plague: OIE chief (Reuters)
• Polymer platform technology innovates drug delivery (EurekAlert)
• Boston Hospitals Lean on 9/11 Lessons in Swift Response (Bloomberg)

Regulatory Reconnaissance #47 - 17 April 2013

Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work.

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Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @AlecGaffney or send him an email at [email protected].