"Such differences clearly could have an impact on patients," he said, "and my view is that sustained-release products are among the relatively short list of products that should not be switched."
Experts say the time release characteristics would be even more difficult to replicate in a generic version of Vancocin, where the concern is not just about how much of the drug is released into the blood stream but rather in one specific section of the GI tract.
The leaking of information in the Vancocin case is reminiscent of a major scandal that erupted during the first Bush Administration in 1989, when FDA officials were charged with taking bribes from generic makers and sharing insider information.
On August 28, 1989, Time magazine reported that an investigation by the Justice Department had uncovered evidence that "some makers of generic pharmaceuticals falsified laboratory test results and paid off FDA chemists to gain quick Government approval for their products."
In that case, Charles Chang the head of the FDA's generic division and two co-workers pleaded guilty to accepting a total of $24,300 in illegal gifts in exchange for preferential treatment for certain generic makers in July 1989, according to the Time report.
In the end, the generic scandal during the first Bush Administration landed Mr Chang in federal prison and caused 42 others and 10 companies to be convicted on charges of fraud and corruption and the FDA Commissioner Frank Young resigned in November 1989.
The crooks in the current Bush Administration's FDA deserve the same fate.
Evelyn Pringle evelyn-pringle@sbcglobal.net
(Evelyn Pringle is a columnist for OpEd News and an investigative reporter focused on exposing corruption in government and corporate America)
