Sunday, July 16, 2006

FDA - little pigs, little pigs let me come in

The consumer group Public Citizen, led by Dr Sydney Wolfe is suing the U.S. Food and Drug Administration to prevent them from holding a closed-door hearing on a blood substitute product.

The suit asks that either the secret hearing be canceled or be opened to the public. The FDA is deciding whether the Navy can test a blood substitute product manufactured by the Biopure Corp. of Cambridge, Mass., The Wall Street Journal has reported.

FDA officials closed the hearing citing "trade secret and-or confidential information" concerns. But Biopure told The Journal it has no objection to a public meeting.

In its lawsuit filed in U.S. District Court in Washington, D.C., Public Citizen says the FDA's decision to close the meeting "has no basis in law or fact" and that the company says "little if any of the information likely to be discussed ... involves Biopure's confidential commercial information or a trade secret."

Biopure maintains its blood substitute product, made from cow's blood, is safe. But previous research suggested the product produced a relatively higher rate of cardiac complications.

1 comment:

Anonymous said...

nearly it was made…