Along with a plea agreement that could see him serving up to a year in prison, Shaun Thaxter is stepping down as CEO of Indivior PLC, of Slough, U.K., a position he’s held since 2009 when the company was known as Reckitt Benckiser Pharmaceuticals, a subsidiary of Reckitt Benckiser (RB) Group. The announcement was made Tuesday, the day Thaxter pleaded guilty in a U.S. district court in Virginia to a misdemeanor count of causing the distribution of misbranded Suboxone (buprenorphine/naloxone) Film in interstate commerce. Under the terms of the plea agreement, Thaxter also will pay $600,000 in fines and forfeiture. He will be sentenced Sept. 29, 2020. The charge stems from Indivior’s efforts to secure formulary coverage for Suboxone Film from Masshealth, the Massachusetts Medicaid agency. According to the U.S. Department of Justice (DoJ), Thaxter asked Indivior employees to devise a strategy to win preferred drug status for Suboxone over a nonopioid competitor Masshealth was considering for opioid-addiction treatment. Subsequently, some of the employees shared false and misleading safety information with the state agency about Suboxone Film’s risk of accidental pediatric exposure. A few months later, Masshealth approved access to the product for Medicaid patients with children younger than 6. The RB Group paid $1.4 billion last year to resolve its liability to the U.S. and various states related to the marketing of Suboxone, according to DoJ.
Glenmark Pharmaceuticals Inc. USA, the North American subsidiary of Mumbai-based Glenmark Pharmaceuticals Ltd., Tuesday became the fifth company charged over the past 13 months with conspiring to fix U.S. prices for generic drugs. The charge, filed in the U.S. District Court in Philadelphia, alleged that Glenmark conspired with at least two other generic drug companies, including Apotex Corp., to increase and maintain prices of cholesterol drug pravastatin and other generic drugs from 2013 to 2015. According to DoJ, the conspirators made at least $200 million through the conspiracy. Similar charges against Apotex and three other companies have been resolved with deferred prosecution agreements. Four senior executives also have been charged, DOJ said, with three entering guilty pleas and the fourth awaiting trial. If found guilty, Glenmark faces a maximum penalty of $100 million or twice the gain derived from the crime, whichever is greater.
Citing the FDA’s complete response letter to Intercept Pharmaceuticals Inc., of New York, stating that the current efficacy and safety data for obeticholic acid was insufficient to support accelerated approval of the drug as a treatment for fibrosis due to nonalcoholic steatohepatitis (NASH), the Institute for Clinical and Economic Review (ICER) announced Wednesday that it is canceling the August 2020 public meeting that had been scheduled to discuss its comparative clinical effectiveness and value assessment of the drug in NASH. However, ICER said it is finalizing a revised evidence report on obeticholic acid, which it plans to publish later this month.
Following last year’s request from Teva Pharmaceutical Industries Ltd., the FDA said it is withdrawing approval of the new drug application for Teva’s Zecuity (sumatriptan iontophoretic) transdermal system, which was approved in 2013 to treat acute migraine. Teva suspended sales, marketing and distribution of Zecuity in June 2016 as it investigated the cause of burns and permanent scarring associated with the system, according to an FDA notice to be published in Thursday’s Federal Register.
The U.S. Patent and Trademark Office (USPTO) Thursday is launching its Fast-Track Appeals Pilot Program, as the Patent Trial and Appeal Board begins accepting petitions for expedited resolution of ex parte appeals. The USPTO said the average ex parte appeal reviewed under the pilot should be decided within six months from the date a petition is granted, as compared with the average 14 months under regular review. Petition grants for the fast-track reviews will be limited to 500 per fiscal year, or 125 per quarter, for the duration of the program. To keep the appeals on schedule, oral hearings will be expedited and, once scheduled, they will not be rescheduled or relocated, according to the USPTO. The petition fee for the program is $400.