FONT-SIZE Plus   Neg

Abbott Reaches Settlement Over Depakote Sales Practices - Quick Facts

Abbott Laboratories (ABT) Monday reached a settlement with U.S. authorities to resolve all outstanding issues regarding a probe of past sales practices relating to its neurologic medication Depakote.

As part of the settlement, Abbott will pay $800 million to resolve civil allegations split among federal and state governments, $700 million for a criminal penalty, and $100 million to states to resolve consumer protection matters. Abbott said the amounts were earlier reserved in anticipation of today's agreement.

Abbott said the settlement with federal and 49 state authorities, plus the District of Columbia, results from a four-year-old investigation into past sales activities that began in 1998 involving Depakote.

The settlement is subject to approval by the Federal Court in the Western District of Virginia.

As part of the resolution, Abbott has agreed to plead guilty to one misdemeanor violation of the Food, Drug and Cosmetic Act for misbranding.

The company also agreed to certain other conditions of settlement, including the maintenance of specified compliance measures and annual certification regarding its state of compliance by its CEO and Board of Directors during a five-year probationary period.

Abbott is to separate into two publicly traded companies by year's end. The company said the compliance measures and certification requirements will transfer to the research-based pharmaceutical company, AbbVie, upon separation, as the obligations relate to the U.S. pharmaceutical business.

Abbott will also enter into a Corporate Integrity Agreement, or CIA, with the Office of Inspector General of the U.S. Department of Health and Human Services. The CIA will govern Abbott's compliance program for a period of five years and builds upon the company's existing comprehensive compliance program. The CIA will also transfer to AbbVie upon separation.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Chipmaker Qualcomm is reportedly in talks with NXP Semiconductor NV (NXPI) for a possible acquisition, reports said. According to Bloomberg, negotiations are on with a probable price of $110 t $120 per NXP share. The deal would value NXP at around $34.7 billion. Regulators have confirmed the eleventh U.S. fatality linked to Takata Corp.'s defective air bag inflators. The National Highway Traffic Safety Administration or NHTSA said Thursday that a crash fatality in Riverside County, California, was tied to the rupture of a recalled Takata air bag inflator. Reynolds American Inc. (RAI) on Friday confirmed that British American Tobacco plc (BATS.L, BTI) has offered to buy the remaining 57.8 percent stake that it does not own in the US tobacco company for $47 billion. Reynolds said its board of directors will evaluate the offer, and respond accordingly to BAT, which currently owns 42.2 percent stake in Reynolds. The proposal represents an enterprise va
comments powered by Disqus
Follow RTT