* Senate health chairman asks FDA for details on recall
* House committee to hold hearing Thursday
* J&J CEO, FDA commissioner not testifying
* Shares down 1.7 percent
(Adds analyst comment, details of Harkin letter, other
background, updates shares)
By Susan Heavey
WASHINGTON, May 25 A U.S. senator is seeking
more information about Johnson & Johnson's (JNJ.N) widespread
recall of over-the-counter children's medicines, expanding on
Congress' investigation of the company's actions.
The letter from Sen. Tom Harkin, chairman of the U.S.
Senate's health committee, comes ahead of a Thursday U.S. House
of Representatives hearing likely to renew attention on J&J.
Also on Tuesday, U.S. health regulators warned J&J over
manufacturing lapses at its Ethicon unit's Advanced
Sterilization Products division. [ID:nN25126916]
While Wall Street has so far shrugged off the recall, the
hearing could trigger investor unease and consumer concerns
over what is the fourth recall for J&J since September 2009.
[ID:nN04125643]. The recall affects Children's Tylenol pain
relievers and dozens of other liquid, nonprescription drugs.
FDA sought the J&J recall after agency inspectors uncovered
contaminated ingredients at the company's Fort Washington,
Pennsylvania, facility, although no finished products were
found to be tainted. Inspectors also spotted grimy equipment,
ceiling holes and other lapses at the plant.
Manufacturing of the liquid medicines has been suspended
until the company fixes all the problems, and FDA officials
have urged parents to give their children generic alternatives
in the meantime.
In a letter to the U.S. Food and Drug Administration sent
late on Monday, Harkin asked the agency's commissioner for more
information on the nationwide recall.
A separate Senate hearing is not currently planned,
Harkin's spokeswoman, Bergen Kenny, told Reuters on Tuesday.
In his letter, Harkin sought details on the company's
actions, including whether it followed proper controls at the
Fort Washington plant and issues concerning its ingredients
supplier. He also said he wanted to ensure that the FDA has
enough power to prevent and respond to drug contamination.
"I am especially concerned because so many of the drugs at
issue in this recall were intended for infants and children,"
Harkin wrote FDA Commissioner Margaret Hamburg.
Representatives for the FDA and J&J had no immediate
comment on Harkin's letter.
The recall will shave J&J's sales by $300 million this
year, JP Morgan analyst Michael Weinstein said on Tuesday in a
research note. Weinstein projects 2010 sales of nearly $62.3
billion for J&J.
Weinstein expects the recall will hurt J&J earnings by 3
cents per share this year, "but the impact could be greater if
remediation costs are higher than expected."
Thursday's House Oversight and Government Reform Committee
hearing aims to shed light on the recall, which began April 30
and also targets pain medicine Motrin as well as allergy drugs
Benadryl and Zyrtec.
Colleen Goggins, Johnson & Johnson's worldwide chairman of
the consumer group, and Josh Sharfstein, FDA's deputy
commissioner, are expected to testify.
J&J Chief Executive Officer William Weldon and the FDA's
Hamburg were invited to speak, but J&J has said Weldon is
recovering from back surgery. Hamburg will be attending an
Institute of Medicine meeting in Moscow, according to the FDA.
Shares of J&J were down 1.7 percent at $59.54 in afternoon
trading the New York Stock Exchange.
(Reporting by Susan Heavey; Adding reporting by Lewis
Krauskopf in New York; Editing by Steve Orlofsky and Matthew