Don't believe everything you read. That's the message from Chinese
drug regulators who say many domestic pharmaceutical companies
claim their products are approved by the
US Food and Drug Administration, but
in fact no Chinese products have ever been approved as a drug by
the FDA.
A
few traditional Chinese medicines have, however, been approved by
the US regulatory body as food, which is much easier to do than
gaining approval as a drug.
"These ads are very misleading," Xu Zhou, a spokesman for the
Shanghai Drug Administration told a three-day US-Sino
Pharmaceutical Regulation Seminar which opened yesterday in
Shanghai.
The seminar, sponsored by the State
Drug Administration of China and the US Department of Commerce,
was organized to help Chinese officials learn how the FDA works and
how Chinese pharmaceutical regulations can be improved.
More than 100 pharmaceutical regulators from around the country
will take part in seminars lead by five experts from the FDA.
Chongqing Taiji Group had to change its ads for a weight-loss
product called Qumei because they claimed the drug was the first
diet pill ever to receive FDA approval. Not true.
Qumei, which means beautiful curves, isn't for sale in the United
States and has never been approved by the FDA, but the product uses
the same main ingredient, Sibutramine, as an American diet pill
called Reductil, which is FDA approved.
An
official from Chongqing Taiji Group said yesterday that the company
realized a few months ago that its ads were not properly phrased
and altered the ads.
Officials at the meeting said ads for another Chinese product,
called Compound Danshen Dropping Pill, are factually correct, but
very misleading to consumers.
The traditional Chinese medicine, which is used to treat coronary
heart disease, is advertised as a drug, but only approved by the
FDA as a food.
"China should do more to build a sound drug registration and safety
supervision system to keep up with developed countries," said Wang
Longxin, director of the Shanghai Drug Administration.
The biggest barrier for Chinese drug manufacturers to receive FDA
approval is the regulator's strict regulations, officials said.
Before the U.S. regulator will approve a new drug, the manufacturer
must provide the FDA with substantial evidence of its safety and
effectiveness based on well-controlled studies, said David A.
Lepay, the FDA's senior adviser for clinical science.
"However, Chinese drug manufacturers engage in many irregular
practices," said Du Wenmin, director of Shanghai Adverse Drug
Reaction Supervision Center.
Because of this, studies performed at domestic research facilities
aren't recognized internationally, so they can't be used to gain
FDA recognition for a product, according to Du Wenmin.
(eastday.com June 7,
2002)