Search Box

Advanced search

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

To my cites       Back to business      Medical rights main

1 2

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."(6 ).

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"(7 ).

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(8 ) .

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(9 ).

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," (10 ).

The end game for the Generic drug scandal of 1989 is almost two dozen sent to prison including five FDA officials. Bolar Pharmaceutical Co. of Copiague New York, paying a $10 million dollar fine for selling $192 million worth of nine adulterated and mislabeled generic drugs(11 ).

FDA also means food

How has the FDA on food safety? It is the called the Food and Drug Administration. The Grocery Manufacturers Association which represent food giants like General Mills ConAgra Foods, wanted increased spending on food safety. The group's vice president for federal affairs Scott Faber, said "Although spending has increased in recent years, that spending has not kept pace with inflation," and "As a result, we've been losing scientists and inspectors and have been unable to keep pace with the growing amount of (food) imports as well as changing consumer preferences,"(12 ).

Over concerns over food safety the US Congress acted (S510). Yet is a one size the best answer, aside from getting votes? The bill will make all food producers no matter how small fall under FDA regulations. The director of Oregon Rural Action an organization that supports local farmers Andrea Malmberg said "It's a one-size-fits-all regulatory mechanism for food facilities." And "It will mean that small producers that sell direct to consumers will have to go through the same regulations as Smith Foods,". A farmer Gus Wahner said the bill might drive him out of business he said "They want to put all these regulations on you, but they don't have any idea how much it's going to cost," (13 ).


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