The U.S. Food and Drug Administration (FDA) is a governmental agency that traces its roots to one employee in the Department of Agriculture in 1862. Today the FDA employs about 15,000 people with a budget in 2014 of $4.4 billion. Those funds are part of the federal budget, and come from tax revenues. The FDA is charged with enforcing laws passed by Congress. The essence of the agency’s work is the protection of the health and safety of the American people.
The FDA’s jurisdiction extends over drugs, both for humans and animals, biological products, medical devices, all items in the nation’s food supply, cosmetics, any product that emits radiation, and all tobacco products. The FDA is charged with ensuring the safety of all these products before they are ever marketed to the public. For example, drugs must be approved by the FDA before they can be marketed and sold to the American people. These decisions concerning the approval of prescription medicines have enormous impact not only on the potential users, but the companies developing the drugs, and the profits to be made from the sales. A decision by the FDA can make or break a drug company, and it can also provide lifesaving medicine to the general populace.
The FDA Center for Drug Evaluation and Research (CDER) works with the pharmaceutical industry in testing and advising concerning drugs prior to being brought to the consumer. Some of these drugs are brand new products, while others are improved versions of a previously approved product. Some examples of drugs approved in 2016 include Epclusa, a drug that treats all major forms of hepatitis C, and zinbryla, a drug that used for patients with multiple sclerosis, there have been many other approvals in 2016 for conditions such as dry eye disease, chronic liver disease, and bladder cancer. The FDA is committed to approving drugs in a timely fashion, while ensuring the safety of the public.
The FDA is headed by a commissioner who is the top official in the agency. His duty is to protect the public from unsafe drugs, while at the same time bringing safe products to the marketplace. Currently, Robert Califf is in this role though he was preceded by Steven Osttroff and Margaret Hamburg. This is a balancing act which protects the public, and promotes the public welfare and health of the American people.