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"Coastal Flood Warning" ...Coastal Flood Warning now in effect from 7 PM to 11 PM EST Monday... * locations...low lying areas along western Long Island Sound. * Tidal departures...3 1/2 to 4 1/2 ft above astronomical tides in the evening. * Timing...moderate coastal flooding around the times of astronomical high tide...between 7 PM and 11 PM. * Coastal flood impacts...potential for widespread flooding of vulnerable shore roads and adjacent properties due to height of storm tide and wave action. Inundation of 1 to 2 ft in the lowest lying spots. Road closures may be needed. Isolated structural damage may be observed along the immediate shoreline. * Shoreline impacts...elevated water levels in combination with 3 to 5 ft of surf are expected to cause beach erosion and splashover along the shoreline Monday evening. Precautionary/preparedness actions... A coastal Flood Warning means that flooding is expected or occurring. Coastal residents in the warned area should be alert for rising water...and take appropriate action to protect life and property. ...Western l.I. Sound water levels for Monday evening... Coastal............time of......forecast total......flood..... Location...........high Tide.....Water level........category.. ...................................(Mllw/mhhw)................ Kings Point NY.......859 PM....10.6-11.1/2.8-3.3.....Min-mod.. Stamford CT..........821 PM....10.0-10.5/2.2-2.7.....Minor.... Bridgeport CT........818 PM.....9.5-10.0/2.2-2.7.....Minor.... New Haven CT.........817 PM......8.9-9.6/2.2-2.7.....Minor.... Old Field NY.........820 PM......9.3-9.8/2.0-2.5.....Min-mod.. Glen Cove NY.........900 PM....10.2-10.7/2.3-2.8.....Min-mod.. , "High Wind Warning" ...High Wind Warning remains in effect from 1 am Monday to 1 am EST Tuesday... * winds...northeast 30 to 40 mph with gusts 60 to 70 mph. * Timing...winds could begin gusting as high as 45 mph just before daybreak Monday. The strongest winds are expected Monday afternoon and evening. * High wind impacts...damaging winds will blow down trees and power lines. Numerous power outages are expected. Travel will be difficult...especially for high profile vehicles and on elevated roadway and bridges. Precautionary/preparedness actions... A High Wind Warning means a hazardous high wind event is expected or occurring. Sustained wind speeds of at least 40 mph or gusts of 58 mph or more can lead to property damage. , "Storm Warning" ...Storm Warning remains in effect from 1 am Monday to 1 am EST Tuesday... * winds and seas...northeast winds 25 to 35 kt with gusts up to 60 kt. Seas 6 to 10 feet. Precautionary/preparedness actions... A Storm Warning means sustained winds or frequent gusts of 48 to 63 kt are expected or occurring. Recreational boaters should remain in port...or take shelter until winds and waves subside. Commercial vessels should prepare for very strong winds and dangerous sea conditions...and consider remaining in port or taking shelter in port until winds and waves subside. -- Monday Jan.23 17,03:24 AM

AG Schneiderman Announces Settlement with GlaxoSmithKline to End Deceptive Advertising Practices and Off-Label Promotion of Prescription Drugs

Drug Company Launched Ad Campaigns Such as “Happy, Horny, Skinny Pill” to Market Drugs for Purposes Unapproved by U.S. Food and Drug Administration

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New York, NY - June 4, 2014 - Attorney General Eric T. Schneiderman announced today that he, along with 43 other State Attorneys General and the District of Columbia, reached a $105 million settlement with GlaxoSmithKlein, LLC (GSK) arising from alleged improper marketing and promotion of the asthma drug Advair and the anti-depressant drugs Paxil and Wellbutrin.  New York’s share of the settlement is over $4.1 million.  The Attorney General’s settlement relating to Paxil builds on a 2006 New York settlement in which GSK agreed to post summaries of clinical studies and establish and maintain a Clinical Trial Register, an official platform and catalogue for registering clinical trials.
 
“When pharmaceutical companies advertise drugs to consumers, their claims should be backed by the best available science, not just slick marketing,” said Attorney General Schneiderman. “Medical decisions are among the most personal and important decisions an individual makes, and drug companies should be held accountable for misleading claims made in advertising. New Yorkers should be able to trust that ads for prescription medications are medically accurate.”
 
In a complaint filed in New York County Supreme Court, Attorney General Schneiderman alleged that GSK engaged in deceptive and misleading practices when it marketed Advair, Paxil, and Wellbutrin for off-label uses and concealed risks associated with Paxil.  As a result of the states' investigation, GSK agreed to change its marketing of Advair, Paxil, and Wellbutrin and to cease promoting off-label uses of the drugs, which are not approved by the U.S. Food and Drug Administration (FDA).  
 
The Attorney General’s complaint charged, among other things, that GSK promoted Advair for treatment of mild and intermittent asthma even though it was approved by the FDA only for treatment of more serious asthma conditions.  GSK promoted Wellbutrin for treatment of weight loss and sexual dysfunction through its “happy, horny, skinny pill,” campaign, even though these were unapproved uses.  GSK concealed and misrepresented clinical studies that demonstrated Paxil’s ineffectiveness in treating children and adolescents with major depressive disorder, as compared to a placebo group, and that demonstrated a connection between Paxil’s use and an increased risk of suicidal thoughts and acts in adolescents.  
 
The settlement prohibits GSK from:
  • Making, or causing to be made, any written or oral claim that is false, misleading, or deceptive about any GSK product;
  • Making promotional claims, not approved or permitted by the FDA, that a GSK product is better, more effective, safer, or has less serious side effects or contraindications than has been demonstrated by substantial evidence or substantial clinical experience;
  • Presenting favorable information or conclusions from a study that is inadequate in design, scope, or conduct to furnish significant support for such information or conclusions, when presenting information about a clinical study regarding GSK products in any promotional materials; 
  • Providing samples of GSK products to those health care professionals who are not expected to prescribe the sampled GSK products for an approved use, but who would be expected to prescribe the sampled product for an off-label use; or
  • Disseminating information describing any off-label use of a GSK product, unless such information and materials are consistent with applicable FDA regulations and FDA Guidances for Industry.  
The Consent Judgment also requires GSK to continue its Patient First Program through March 2019. The Patient First Program reduces financial incentives for sales representatives to engage in deceptive marketing by removing individual sales targets and begins the process of ending direct payments to health care professionals for speaking engagements and attendance at medical conferences.
 
The case was handled by Assistant Attorney General Benjamin J. Lee, Deputy Bureau Chief Laura J. Levine and Bureau Chief Jane M. Azia, all of the Consumer Frauds Bureau. The Consumer Frauds Bureau is part of the Division of Economic Justice, led by Executive Deputy Attorney General for Economic Justice Karla G. Sanchez.
 
The settlement papers can be read here and here.