UPDATE: Abbott Labs: US Justice Department Probing Depakote
(Adds background information, updated stock price, in the sixth through ninth
paragraphs.)
By Peter Loftus
Of DOW JONES NEWSWIRES
The U.S. Justice Department is investigating Abbott Laboratories' (ABT) sales
and marketing activities for its anti-seizure drug Depakote, the drug maker
disclosed Friday.
Abbott said in a regulatory filing that the U.S. Attorney for the Western
District of Virginia is seeking to determine whether Abbott's marketing
activities violated civil or criminal laws including the Federal False Claims
Act, the Food and Drug Cosmetic Act, and the Anti-Kickback Statute "in
connection with Medicare and/or Medicaid reimbursement to third parties."
Abbott spokeswoman Adelle Infante said the Abbott Park, Ill., company is
cooperating with the investigation, but declined further comment.
A spokesman for the U.S. Attorney in the Western District of Virginia couldn't
immediately be reached.
Depakote is approved to treat bipolar disorder and seizures and to prevent
migraine headaches. Sales declined 70% to $354 million for the first nine months
of 2009 due to generic competition.
Earlier this year, the U.S. Food and Drug Administration sent Abbott a warning
letter saying that a promotional material for Depakote was misleading and
violated federal law. A promotional flashcard shown to health-care professionals
omitted certain information about the drug's risks and overstated the approved
uses of the drug, the FDA said. Abbott stopped using the material.
Last year, the FDA required the prescribing labels for Depakote and other
anti-epileptic drugs to carry warnings that the drugs increase the risk of
suicidal thoughts and behaviors.
Many large drug makers have come under legal scrutiny for their marketing
practices in recent years, particularly for "off-label" marketing, or promoting
a drug for unapproved uses. Pfizer Inc. (PFE) recently agreed to a record $2.3
billion settlement of government civil and criminal allegations that it
illegally promoted the pain drug Bextra and others.
Abbott shares fell 14 cents, to $51.48 in recent trading.
-By Peter Loftus, Dow Jones Newswires; 215-656-8289; peter.loftus@dowjones.com
(END) Dow Jones Newswires
11-06-091516ET
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