WHO To Avoid Tuberculosis Drugs Made By Wyeth In Pakistan
April 28 2009 - 1:02PM
Dow Jones News
The World Health Organization, saying it can't assure the
quality of several tuberculosis products made at a Wyeth (WYE)
plant in Pakistan, will suspend purchases of the drugs.
Wyeth Pakistan Ltd., a unit of Wyeth, introduced new active
ingredients into the medications and changed the storage conditions
without getting approval of the WHO, according to a letter the
agency sent the company on Monday. The letter was posted online
Tuesday.
The suspension affects four drugs manufactured at the plant that
are used to treat tuberculosis, a deadly infectious disease that
commonly affects the lungs.
Although it's unclear exactly how the suspension will affect
Wyeth, it likely means a host of aid agencies across the globe will
stop purchasing the medicines, said Roger Bate, Legatum fellow at
the American Enterprise Institute.
Wyeth spokesman Doug Petkus said the facility has about 300
employees and serves as an administrative and manufacturing plant.
He said the company has just received the notification and is
reviewing it. Wyeth will work with WHO to address the matters, he
said.
The tuberculosis drugs are made and distributed under a WHO
program started in 2001 that gives third-world countries access to
safe, effective and quality medicines.
The WHO letter says that it inspected Wyeth Pakistan's facility
in 2005 and found that it wasn't complying with good manufacturing
practices to ensure the quality of medicines. It's unclear whether
the company has since brought its manufacturing practices in line
with those standards. A WHO spokesman wasn't immediately available
to comment.
These type of letters from the WHO, called notices of concern,
aren't cause for public concern. If WHO identifies a public health
risk, it will take other steps to alert the public.
Bate said, however, "this is not good for Wyeth." He said aid
agencies, such as the United States Agency for International
Development, often make decisions months ahead of time about where
it will buy products to distribute to underprivileged
countries.
"The impact on the company is often bad because at any one
moment people across the world will be considering [where] to
procure drugs, and Wyeth is off the table," Bate said.
-By Jared A. Favole, Dow Jones Newswires; 202.862.9207;
jared.favole@dowjones.com