Regulatory Agencies and Business Ethics

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Hi,

Interesting question! Let's take a closer look.

RESPONSE:

1. How do regulatory agencies like the FDA fit in the body of law? Are they superior to courts? Are they inferior to Statutes? What about state law?

The Food and Drug Administration (FDA) is an agency within the U.S. Public Health Service, which is a part of the Department of Health and Human Services. The FDA has one role and function in the body of law, whereas the courts have another. Either the FDA or the courts are inferior or superior, but work together as a system of law. Statues or laws enacted by a legislature and FDA regulations also work together, and do not contradict one another, as it is for state law as well. For example, the FDA might investigate allegations (in the areas listed below), and then charges might be brought against the party who is in violation, but the court actually handles the case.

See attached FDA investigation, which illustrates the interaction between the FDA and the courts. For example, in regards to inspections and legal sanctions, FDA investigators and inspectors collect domestic and imported product samples for scientific examination and for label checks. If a company is found violating a law that FDA enforces, FDA can encourage the firm to voluntarily correct the problem or to recall a faulty product from the market. When a company can't (or won't) correct a public health problem with one of its products voluntarily, FDA has legal sanctions it can bring to bear. FDA can go to court to force a company to stop selling a product and to have items already produced seized and destroyed. When warranted, criminal penalties--including prison sentences--are sought against manufacturers and distributors ...