Regulatory Reconnaissance (18 April 2013)

Good morning and welcome to another edition of Regulatory Reconnaissance.

In the US, GSK/Theravance's new lung drug gets approval from an FDA panel, a report chides FDA for not following up on drugs approved with faulty testing, FDA reviewers express concern about a Low-T treatment, Alkermes' potential blockbuster antidepressant gets good Ph II results, GSK manufacturing delays cause a shortage, FDA releases 12 new 483's on deficient compounders, GPhA announces its support of a decision that delays generics, a circuit court kills a failure-to-warn suit, Baxter gets a warning letter, CDRH is working to update a guidance document on appeals, more glucose meter recalls, FDA's Class III device decisions are called 'curious,' and a warning letter to a supplement company alleges advertising deficiencies.

Abroad, EMA publishes its annual report, an upcoming meeting will discuss ENVI's proposed medical device regulation framework, a breast implant trial in France gets underway, a Chinese manufacturer takes a huge earnings hit after dealing with contaminated capsules last year, a CEO blasts second-guessing of EMA's methodologies, a new EU IVD proposal is reviewed, Australia's TGA issues warnings, and Cipla launches a new biosimilar product that is manufactured in China.

Plus: Could nutraceuticals be the next big growth area for pharmaceutical companies? And what regulatory challenges does that raise?

Five in Focus

1. FDA advisory panel backs Glaxo/Theravance lung drug (Reuters) (Medscape) (The Pink Sheet) (Pharma Times) (Fierce Biotech) (RTT) (BioCentury) (SCRIP Intelligence) (The Pharma Letter) (Med Page Today)
2. European Medicines Agency publishes 2012 annual report (EMA) (Report)
3. Victims of breast implants seek compensation in France (Reuters) (EurActiv) (AP) (NYTimes)
4. Double Dose: In Second Case of Flawed Drug Research, FDA Response Was Slow and Secretive (ProPublica)
5. CDRH Working to Update Appeals Guidance for Consistency with FDASIA (FDA Law Blog)

US

Pharmaceuticals/Biotechnology

• Double Dose: In Second Case of Flawed Drug Research, FDA Response Was Slow and Secretive (ProPublica)
• FDA advisory panel backs Glaxo/Theravance lung drug (Reuters) (Medscape) (The Pink Sheet) (Pharma Times) (Fierce Biotech) (RTT) (BioCentury) (SCRIP Intelligence) (The Pharma Letter) (Med Page Today)
• FDA Reviewers Concerned About Low-T Drug (Med Page Today)
• GSK's Contract Manufacturing Delays Cause Shortage of Restless Leg Treatment (Outsourcing Pharma)
• How A Mourning Entrepreneur And A Dogged Doctor Rescued A Rare Disease Drug (Forbes)
• Upton and Coburn Issue Statement on FDA Opioid Drug Application Ruling (E&C)
• FDA's Criminal Enforcement Priorities Protecting Public Health (FDA Voice)
• Alkermes reveals PhII success with antidepressant in blockbuster CNS plan (Fierce Biotech) (BioCentury) (SCRIP Intelligence) ($) (Bloomberg) (The Pharma Letter)
• Pharming/Santarus make second US attempt with Ruconest (SCRIP Intelligence) ($) (BioCentury) (The Pharma Letter)
• 12 New Form 483 Letters to Comopounding Pharmacies Posted by FDA (FDA)
• Eli Lilly rolls the dice on combo approach against Alzheimer's disease (Fierce Biotech) (Eli Lilly)
• Drug pipeline for worst superbugs "on life support": report (Reuters)
• FDA approves Phase II of stem cell trial for ALS (Detroit Free Press) (EurekAlert)
• Sandoz launches generic cardiovascular disease drug (DSN)
• 5th Circ. Quashes Generic Reglan Failure-To-Warn Suit (Law 360) ($)
• Respecting FDA's (Inherent) Authority (Drug and Device Law)
• GPhA Says FDA's OxyContin Decision Is Overdue (GPhA) (FDA News) ($)
• FDA Making Good on GAIN Act's Antibiotic Goals (FDA News) ($)
• Exact Sciences Colon Cancer Screen Results Disappoint Wall Street (Reuters) (The Street)
• Sanofi Gets Approval for Manufacturing Changes for Allegra (FDA)
• Schering Plough Gets Approval for Manufacturing Changes to Claratin (FDA)
• FDA Approves Labeling Revision for Novo Nordisk's Victoza (FDA)
• FDA Approves Sandoz's Generic Pioglitazone Hydrochloride and Metformin Hydrochloride (FDA)
• FDA Approves Manufacturing Changes for BMS's Entecavir and LG Life's Valtropin (FDA)

Medical Devices

• Baxter Hit With Warning Letter for Sigma Spectrum Infusion Pump (FDA) (Fierce Medical Devices)
• CDRH Working to Update Appeals Guidance for Consistency with FDASIA (FDA Law Blog)
• Abbott Initiates Voluntary Recall of FreeStyle lnsulinx Blood Glucose Meters in the United States (FDA)
• J&J Subsidiary Lifescan Issues Another Recall Regarding its OneTouch Ultra Blood Glucose Meters, This Time Because the Meter May Display Incorrect Results (FDA)
• Curiouser and Curiouser… Petitioner on Class III Devices Gets an Answer from FDA (MDDI)
• Could "sunshine" rules squash medical device innovation? (Mass Device)
• Should FDA Really be Making an Adverse Event Reporting App? (Placebo Control)
• GE Issues a Class 2 Recall for a Medical Software System Server (FDA)
• FDA Clears Molnlycke Transfer Dressing That Offers Reduction in Trauma and Infection Risk (Infection Control Today)
• FDA Approves FibroScan(R) For Non-Invasive Liver Diagnosis (Medical News Today)

Assorted

• US Court of Appeals Rules that Off Label Promotion May Be Treated as Racketeering in Civil Litigation (Policy and Medicine)
• Enforcement Report - Week of April 17, 2013 (FDA)
• FDA Pre-Approval of Dietary Supplements Debated (Natural Products Insider)
• Landmark Trial for Personalized Medicine Coming Soon: NGS Approval May Be One Offshoot of Lung Cancer "Master Protocol" (RPM Report) ($)
• CDISC and C-Path Release New Kidney Disease Data Standard for use in Clinical Trials (CDISC)
• Warning Letter to Supplement Company Alleges Misbranding, Advertising Issues and CGMP Violations (FDA)
• Get Your Facts Fast - FOIA Requests May Be Expedited (Law 360) ($)

Government and Budget

• Medical device tax: Repeal efforts hinge on "prearranged" deal with the Senate, Reps say (Mass Device)

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

• European Medicines Agency publishes 2012 annual report (EMA) (Report)
• EMA finds MAAs increasingly complex (SCRIP Intelligence) ($)
• 24 April Meeting of ENVI to Discuss New Medical Device Regulation Framework (ENVI)
• Victims of breast implants seek compensation in France (Reuters) (EurActiv) (AP) (NYTimes)
• Contaminated capsules dissolve Chinese company Biostar's earnings (Fierce Pharma Manufacturing)
•  'Monday morning quarterbacks' question EMA rigor, says unreimbursed CEO (SCRIP Intelligence) ($)
• Rapporteur Liese's IVD regulation amendments are out: not so horizontal as expected (Medical Devices Legal)
• Cipla steamrolls into Enbrel market with biosimilar of Amgen drug (Fierce Pharma) (Cipla) (BioCentury) (PharmAsia News) (Biosimilar News) (BioSpectrum Asia)
• Australia Issues Warnings About Two Drugs Containing Sildenafil (TGA) (TGA)

General Regulatory and Interesting Articles

• Merck Could Return To Greatness If CEO Can Leave His Own Past Behind (Forbes)
• Deadly ricin: poisonous but clumsy weapon (NBC) (Washington Post) (NPR)
• Authorities must get tough on bad science (Financial Times)
• Paying for cancer drugs in the US and abroad (The Incidental Economist)
• Nutraceuticals: Big Pharma or Big Food's next Big Growth area? (PMLive)

Regulatory Reconnaissance #48 - 18 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].