Regulation & Policy

Reports in this category will address the important role of regulation and policy in the healthcare market. As a highly regulated industry in most countries, healthcare marketers need to be aware of regulations in the countries where they sell products. Regulation will commonly refer to the actions of administrative bodies and existing laws, where as Policy would include potential laws and partial actions of state legislatures or congress.

Given that regulatory activity in the healthcare industry is intense and that policy debates are numerous, pharmaceutical or device markets need an awareness of what laws apply to their products.

In the United States drugs, diagnostics and medical devices are regulated by the Food and Drug Administration (FDA). The FDA is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments. The FDA is responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), veterinary products, and cosmetics.

The FDA derives its power from the Food, Drug and Cosmetic Act,[7] (Passed in 1938 and amended since) and are codified in Title 21, Chapter 9 of the United States Code. Some other laws that impact the FDA’s authority is Public Health Service Act, parts of the Controlled Substances Act, the Federal Anti-Tampering Act.