UPDATE: FDA Closes Inquiry Into Mylan Plant Without Issues
14 8월 2009 - 1:48AM
Dow Jones News
The Food and Drug Administration has closed its investigation
into Mylan Inc.'s (MYL) Morgantown, W.Va., plant, finding no
deficencies, following media reports that questioned its quality
control.
The potential issues came to light last month in a Pittsburgh
Post-Gazette report, which alleged that plant workers were
overriding computer-generated warnings. Confusing statements from
both the company and regulators created volatility in the generic
drug maker's stock price.
Mylan shares, which were as low as $11.66 last month, jumped on
the news Thursday, recently rising 3.4% to $14.06.
An FDA spokeswoman said the agency "plans no additional action."
She said Mylan appeared to conduct an "adequate investigation" of
the matter, with no evidence that there was any adverse impact to
affected product lots.
"No data was deleted, and the audit trails were intact for each
instance where the software was overridden by the operator,"
according to the agency's statement.
Furthermore, Mylan provided training to operators and was
working to implement a software patch that would prevent employees
from overriding data.
Last month, the Post-Gazette 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.
Officials from the Post-Gazette weren't immediately available
for comment.
Mylan Chief Executive Robert Coury has blasted the reporting in
the article and said it contained "false, misleading and unfounded"
allegations with a "biased agenda."
The FDA's conclusion, as well as Mylan's strong reaction, should
ease investor concerns.
"The fact management squashed these shocking allegations so
quickly dissolves any credibility doubts and puts the focus back
where it belongs," Natixis Bleichroeder analyst Corey Davis said,
stressing Mylan's recent second-quarter earnings report and 2009
projections.
-Thomas Gryta; Dow Jones Newswires; 212-416-2169;
thomas.gryta@dowjones.com