Is the FDA Cowed by Industry?

The mission of the U.S. Food and Drug Administration (FDA) is as follows:

The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health. [link]

Nowhere in this statement does it say that the FDA is equally responsible for protecting the interests and profits of those corporations that develop and manufacture products over which the agency has oversight. Nor does it even infer that anything other than protecting and advancing the public health is the central purpose of the agency. Yet, all too often these days, the FDA seems to be siding with industry and turning a blind or indifferent eye to the public health risks of certain products. Consider the case of the cattle antibiotic, cefquinome, as reported here by the Washington Post:

FDA Rules Override Warnings About Drug

The government is on track to approve a new antibiotic to treat a pneumonia-like disease in cattle, despite warnings from health groups and a majority of the agency’s own expert advisers that the decision will be dangerous for people.

The drug, called cefquinome, belongs to a class of highly potent antibiotics that are among medicine’s last defenses against several serious human infections. No drug from that class has been approved in the United States for use in animals.

The American Medical Association and about a dozen other health groups warned the Food and Drug Administration that giving cefquinome to animals would probably speed the emergence of microbes resistant to that important class of antibiotics, as has happened with other drugs. Those super-microbes could then spread to people.

Echoing those concerns, the FDA’s advisory board last fall voted to reject the request by InterVet Inc. of Millsboro, Del., to market the drug for cattle.

Yet by all indications, the FDA will approve cefquinome this spring. That outcome is all but required, officials said, by a recently implemented “guidance document” that codifies how to weigh the threats to human health posed by proposed new animal drugs.

The wording of “Guidance for Industry #152” was crafted within the FDA after a long struggle. In the end, the agency adopted language that, for drugs like cefquinome, is more deferential to pharmaceutical companies than is recommended by the World Health Organization. [full text]

2 thoughts on “Is the FDA Cowed by Industry?

  1. Guess we’ll all have to become vegetarians. Let the beef industry deal with that.

  2. Sounds good to me, Miami Mama. I’ve been a vegetarian since 1978. My grandmother used to refer to such as “that crazy diet.” Unfortunately, what is really crazy is the health risk the FDA and the beef/dairy industry may be exposing American citizens to by allowing the use of powerful antibiotics like cefquinome on cattle. In my mind, the risks far outweigh any benefits.

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