Ranbaxy settles Texas Medicaid drug-pricing suit for nearly $40M | FDA seeks better drug quality with restructuring | Upton's omnibus bill may change FDA oversight of pharma communications
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October 17, 2014
FDLI SmartBrief
News for the food and drug law community

Drugs & Biologics
Ranbaxy settles Texas Medicaid drug-pricing suit for nearly $40M
Ranbaxy Laboratories reached a $39.75 million settlement deal with federal authorities to resolve a lawsuit related to the way in which it disclosed pricing information to Texas Medicaid for certain drugs. The drugmaker said it will pay the penalty in tranches through August 2015. The settlement comes after Ranbaxy's guilty plea in 2013 to felony charges tied to drug safety. Reuters (10/16) Share: Email
FDA seeks better drug quality with restructuring
The FDA will embark on a new push to focus on drug products' quality by launching the Office of Pharmaceutical Quality on Jan. 1. Center for Drug Evaluation and Research Director Dr. Janet Woodcock will serve as the office's first acting director and said the reorganization will better align CDER's drug quality functions, which include research, inspection and review. Regulatory Focus (10/16)
Upton's omnibus bill may change FDA oversight of pharma communications
Off-label communications could be addressed in an omnibus bill planned by House Energy and Commerce Committee Chairman Fred Upton, R-Mich. This would be welcome news for doctors and patients with conditions without a straightforward cure who require access to all the clinical data available, John Osborn writes. Forbes (10/16)
FDA examines link between pill changes, adherence
The FDA is planning a survey of about 3,000 pharmacists and patients to examine how changes in a pill's appearance such as the color affect medication adherence, especially for generic drugs. Previous studies suggest changes in a drug's physical characteristics were associated with reduced adherence and higher medical costs. The Wall Street Journal (tiered subscription model)/Pharmalot blog (10/16) Share: Email
Global Focus
Critics say TPP draft would cause drug prices to go up
The cost of drugs will go up if draft proposals in the Trans-Pacific Partnership negotiations are adopted, health and consumer rights advocates said Thursday. The Pharmaceutical Research and Manufacturers of America said strong intellectual property protections are needed to support innovation. Mark Elliot of the U.S. Chamber of Commerce's Global Intellectual Property Center said the strong presence of generics in the U.S. shows patent protections are compatible with access to treatments. Reuters (10/16) Share: Email
Modi: No moves to hike up drug costs in India
Indian Prime Minister Narendra Modi said Thursday that his government would not take steps that cause the price of drugs to increase. A Kerala ministerial delegation headed by Chief Minister Oommen Chandy expressed concern to Modi about possible price increases for drugs that treat conditions such as diabetes, malaria, tuberculosis, HIV and cancer. The Economic Times (India)/Press Trust of India (10/16) Share: Email
Food & Dietary Supplements
Undeclared milk prompts recall of Monica brand snacks in Canada
Monica brand snacks were pulled by OEY Trading and the Canadian Food Inspection Agency because of milk not declared on the label. The affected products, sold in Quebec and Ontario in 410-gram packs, include Superior Quality Layer Snack Chocolate Flavour with UPC number 7 33894 22306 3 and Superior Quality Layer Snack Special Original Flavour with UPC number 7 33894 22301 8. Food Poisoning Bulletin (10/16) Share: Email
Medical Devices
Siemens' advanced cardiovascular ultrasound scanner gets FDA OK
Siemens Healthcare has received FDA clearance for the Acuson SC2000 Prime, the latest version of its ultrasound scanner used for cardiovascular imaging. The company said the system gives doctors a single view of both the heart and dynamic blood flow when performing interventional valve procedures. AuntMinnie.com (free registration) (10/16) Share: Email
FDA clears cervical fusion device from Precision Spine
The FDA has cleared Precision Spine to market its Vault-C Anterior Cervical Interbody Fusion Device, which the company said is now available commercially. The device comes with a zero profile design to provide stable screw fixation while keeping surrounding soft tissue and vessels unharmed. FDAnews (10/16) Share: Email
ITraumaCare's bleeding-control device gets expanded approval from FDA
The FDA has granted iTraumaCare expanded approval for its iTClamp Hemorrhage Control System for use in halting severe bleeding in patients with traumatic injuries in the neck. The device previously was approved for use on the leg, arm, scalp and groin. San Antonio Express-News (10/16) Share: Email
FDLI Items
Enforcement, Litigation, and Compliance Conference, Dec. 8-9
FDLI's annual conference on enforcement trends and strategies for compliance will include a discussion on "International Enforcement and Compliance Initiatives." Hear speakers discuss FDA's enforcement role with imported products, the increase in inspections and warning letters in India, the Transatlantic Trade and Investment Partnership (TTIP), and the Trusted Trader Program. This year, we will also feature breakout sessions specific to your industry: food, drugs, medical devices and tobacco. View the agenda and register. Share: Email
FDLI's 2014 Intro to Tobacco Conference on Oct. 20: Just 3 days away!
On Oct. 20, just three days away, FDLI's first Intro to Tobacco Conference will be taking place at the Hotel Monaco in Washington, D.C. Our faculty will provide unbiased and practical information on the Tobacco Control Act, the FDA's approach to regulating tobacco products, substantial equivalence, harm reduction efforts and the regulation of e-cigarettes, cigars and smokeless tobacco. Register now if you would like to attend and receive a free digital copy of FDLI's Tobacco Primer with registration! Share: Email
Who's Hiring?
Position TitleCompany NameLocation
Counsel I – Clinical Contracts Gilead SciencesFoster City, CA
Director, Antibiotics and Innovation ProjectThe Pew Charitable TrustsWashington, DC
Director of LitigationCenter for Science in the Public InterestWashington, DC
Associate General CounselPatient-Centered Outcomes Research InstituteWashington, D.C , DC
Compliance Sr MgrAmgenThousand Oaks, CA
ParalegalMylan Inc.Washington, DC
Associate - Food and Drug Keller and Heckman LLPWashington, DC
Paralegal, Legal-RegulatoryConfidentialPiscataway, NJ
Click here to view more job listings.
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-- Mark Twain,
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