UPDATE: FDA Says Investigation Into Mylan Facility Is Ongoing
29 7월 2009 - 2:22AM
Dow Jones News
The U.S. Food and Drug Administration said it is continuing its
investigation into possible quality control issues at Mylan Inc.'s
(MYL) Morgantown, W.Va., manufacturing facility, contrary to a
statement made by the generic drug maker earlier Tuesday.
In response to the FDA statement, a Mylan spokesman said "our
CEO would never have gone out with a statement like that without
being informed of the closeout of the FDA inspection."
Officials from the FDA weren't immediately available to respond
to Mylan's latest comments.
"This investigation involves allegations of compliance
violations that the FDA takes very seriously," Steven Solomon,
FDA's Assistant Commissioner for Compliance Policy in the Office of
Regulatory Affairs, said in a statement Tuesday.
"The investigation is on-going and the agency has formed no
conclusions at this time. Statements to the contrary are untrue,"
he said.
Earlier Tuesday, the company had issued a press release saying
the FDA had visited the manufacturing facility on Monday and
determined that "the baseless accusations in the article were
unfounded."
Shares of Mylan dropped after the FDA's comments, recently
trading up 3.3% to $12.50 on more than four times regular trading
volume. The stock traded as high as $13.37 earlier Tuesday after
dropping 12.6% on Monday, following a Pittsburgh Post-Gazette story
Sunday.
The newspaper reported that Mylan had launched an internal probe
to investigate whether workers at the plant had been routinely
overriding computer-generated warnings about the drugs being
produced at the plant. The newspaper cited an internal report and
had other experts review the report and call it a significant
problem.
Mylan said Monday that the issue had "no impact on the quality
of our product."
Tuesday, Mylan said the agency "noted there was no evidence of
any data deletion. All data was reviewed and was present and
accounted for."
-Thomas Gryta; Dow Jones Newswires; 212-416-2169;
thomas.gryta@dowjones.com