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Medical Rights Medical Rights, American Therapeutics, Generic Drugs,  U.S. Food and Drug Administration, ANDA, favoritism, AIDS, cancer, drug

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Executive director of Trust for America's Health Jeffrey Levi said Americas food safety system is "plagued with problems,". Michelle Larkin of the Robert Wood Johnson Foundation said it was "We are way overdue for a makeover," and . "It costs us around $44 billion annually in medical care and lost productivity, so the stakes are really high."(17).

Former FDA commissioner Dr. Herbert Ley said "The thing that bugs me is that the people think FDA is protecting them. It isn't. What the FDA is doing and what the public thinks it's doing are as is different as night and day"(18).

In 1984 the Drug Price Competition and Patent Term Restoration Act of 1984 led to the Abbreviated New Drug Applications (ANDA) the act led to looser oversight. The Sponsor of generic didn't have to submit any clinical data other than the results of bio equivalence tests(19)

The US House Energy and Commerce Subcommittee on Oversight and Investigations thorough its own investigations discovered that F.D.A. officials, Charles Y. Chang and David J. Brancato took bribes from generic drug makers American Therapeutics Inc., Par Pharmaceuticals and Pharmaceutical Basics Inc. in 1989(20).

It was charged that supervisory chemist Charles Chang, received accepted furniture, a computer, and a round-the-world trip from American Therapeutics of Bohemia, New York. Charles Chang said "I was a supervisory chemist in the Division of Generic Drugs of the U.S. Food and Drug Administration from January 1985 to April 1989. . . . I was the supervisory chemist for Branch III, one of three chemistry review branches in the division. I was recommended for that position by Dr. Marvin Seife, the director of the division, and reported to Dr. Seife . . . . Prior to that I was a review chemist in the Division of Generic Drugs for almost nine years. . . ." and also said "Favoritism and special handling of applications were common in the Division of Generic Drugs. I was involved in this, as were many others, including the director of the division and the chief of the review support branch. Examples include numerous occasions when I was asked to take ANDAs [abbreviated new drug applications] out of turn or to approve them as soon as possible on an expedited basis. This favoritism was not necessarily the result of illegal behavior, but reflected, in part, highly personal, arbitrary, and often arrogant management. Other examples of favoritism were the result of continuous pressure put on the division, at all levels, by the industry through lobbying," (21 ).

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Medical Rights, American Therapeutics, Generic Drugs,  U.S. Food and Drug Administration, ANDA, favoritism, AIDS, cancer, drug