«

»

Dub
07

Abbott pleaded guilty to a crime of misreprescing depakote in violation of the FDCA. According to the plea, Abbott will pay a $500 million fine, expire $198.5 million in assets and submit to a five-year suspended sentence. In addition, Abbott will contribute US$1.5 million to the Virginia Medicaid Fraud Control Unit. „Following OIG`s joint investigation with our federal and regional partners, Abbott Laboratories is entering one of the largest colonies in the pharmaceutical industry and is paying $1.5 billion for the illegal promotion of its drug Depakote, including for patients in dementia,“ said Daniel R. Levinson, Inspector General of HHS. „Our integrity agreement will make Abbott accountable for preventing future violations of federal health laws and FDA requirements that will protect federal programs, taxpayers and our most vulnerable patients.“ Abbott will pay $800 million to settle civil charges shared between the federal state and the federal states, $700 million for a criminal fine and $100 million to the states to resolve consumer protection issues. These amounts have been set aside in advance of today`s agreement. Neither Abbott nor AbbVie admitted that wrongdoing was part of the comparison, and neither company was obligated to enter into an agreement on the integrity of the company – a promise to improve compliance practices and behave – even though they are a common feature of the Department of Justice`s marketing regulations. Certain statements contained in this press release may be forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including the planned separation of the pharmaceutical company based on the research of the diversified medical device company and the expected financial results of the two companies after the separation.

Abbott cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed in the forward-looking statements. Economic, competitive, governmental, technological and other factors that may affect Abbott`s business are discussed in item 1A, „risk factors,“ in our Annual Report on The Securities and Exchange Commission`s Form 10-K for the past year, and are used as a reference. Abbott undertakes no commitment to publicly publish any changes to forward-looking statements as a result of future events or developments. Abbott must implement a grant monitoring program through which it must conduct audits of at least 30 medical training scholarships in the United States for each reference period. Abbott pleaded guilty to misreprescing Depakote by promoting the drug to control agitation and aggression in elderly dementia patients and treating schizophrenia if none of these uses were approved by the FDA. In an agreed statement of facts filed in the criminal complaint, Abbott acknowledges that between 1998 and 2006, the company had a specialized sales agent responsible for marketing depakote in nursing homes for agitation and aggression control in elderly dementia patients, when there was no credible scientific evidence that Depakote was safe and effective for this use. In addition, from 2001 to 2006, the company marketed Depakote in combination with atypical antipsychotics to treat schizophrenia, even after its clinical studies did not demonstrate that the addition of Dépakote was more effective for this use than an atypical antipsychotic. „Today`s comparison shows that we continue to carefully review the sales and marketing practices of pharmaceutical companies that place profits above patient health,“ the United States said.