June 10, 2010: Press Releases Regarding Pediacare and Motrin Recall
On June 2, the Committee on Oversight and Government
Reform posted press releases regarding recent developments concerning McNeil
and Johnson & Johnson.
The first release outlines a letter from Chairman Edolphus
Towns (D-NY) asking Johnson & Johnson for more details in what Downs has
described as a “phantom recall.”
The release states that the committee is seeking more
information about whether or not the company hired a private contractor to
visit retail stores and secretly purchase suspect Motrin rather than notifying the Food and Drug
Administration (FDA) about problems with the medication.
The committee learned of the “phantom recall” through an
internal document uncovered as the committee preparing a hearing with Johnson
and Johnson regarding recent drug recalls.
The document is entitled "CSCS Motrin Purchase Project" and the
contractor was instructed as follows:
You should simply "act" like a regular
customer while making these purchases. THERE MUST BE NO MENTION OF THIS BEING A RECALL OF THE PRODUCT!
(emphasis in the original)
Chairman Downs explains in his letter to Johnson & Johnson:
It was not until the FDA caught Johnson and Johnson in
the midst of the phantom recall that the company announced a proper recall of
the flawed Motrin.
I am deeply concerned about this incident and I intend
to get the bottom of it. The American people have trusted Johnson & Johnson
for more than 100 years but what have uncovered raises serious questions about
the integrity of this company.”
The second release described a letter from Chairman Towns
to Blacksmith Brand regarding a recent recall of Pediacare products manufactured at plant scrutinized by
the FDA and shut down by Johnson & Johnson in connection with a recall of over 130 million bottles of
pediatric medicine.
Downs’ asked the company to provide answers to the
following questions:
1. Is Blacksmith aware of any defect or contamination
in any Blacksmith product that was
manufactured at Johnson & Johnson/McNeil's Fort Washington,
Pennsylvania plant? If so, please explain.
2. Has Blacksmith received any reports of adverse
events related to the recalled Blacksmith
products? If so, please provide a list of all such adverse
events.
3. Please provide copies of all records relating to
Blacksmith’s May 28, 2010 recall of
pediatric medicine, including all communications between Blacksmith and
Johnson & Johnson, McNeil, and
the U.S. Food and Drug Administration.
Chairman
Downs’ gave the company a 4pm, June 10th deadline to provide the
proper information to the committee.
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