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Merck & Co. Receives Subpoena from U.S. Regulators

By Pharmaceutical Processing | August 9, 2011

Merck & Co. disclosed Monday in an SEC filing that it received a
subpoena from the US Department of Justice as part of a “federal health
care investigation under criminal statutes” into the company’s marketing
of three drugs acquired in its merger with Schering-Plough. Merck spokesman Ron Rogers said the drugmaker is cooperating with the probe.

Specifically, the agency requested information from January 2004 to
the present on the brain cancer drug Temodar (temozolomide), hepatitis C
therapy PegIntron (pegylated interferon alfa-2b), and Intron A
(interferon alfa-2b), which is approved for the treatment of certain
cancers and other conditions. Sales of the drugs totalled $481 million,
$319 million and $96 million, respectively, in the first six months of
this year.

 

Separately, Merck revealed that the justice department and
Environmental Protection Agency (EPA) are pursuing civil penalties of
more than $2 million against the company for alleged violations of
environmental regulations at two Pennsylvania facilities. The action
results from the EPA’s inspection of the West Point and Riverside sites
in 2006, and Merck’s submission of information to the agency. However,
the drugmaker indicated that it believes it has meritorious defences
against the allegations.

 

In addition, Merck said that it agreed to pay a $260 000 fine and
sign a consent decree to resolve alleged environmental violations at its
Las Piedras facility in Puerto Rico in connection with an EPA
inspection in 2008.

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