U.S. Food and Drug Administration
The U.S. Food and Drug Administration (FDA) is one of the nation's oldest consumer protection agencies. Its mission is “to promote and protect the public health by helping safe and effective products reach the market in a timely way, to monitor products for continued safety after they are in use, and to help the public get the accurate, science-based information needed to improve health.”
The FDA is typically the agency that alerts Americans about the potential health risks of certain foods.
Fact
In September of 2006, people in numerous states began to get very ill. The FDA determined that their illness was caused by loose, bagged spinach. Some spinach had been infected with deadly E. coli bacteria. At first, the FDA did not know which company had processed the tainted spinach, so all bagged spinach was removed from supermarket shelves.
The FDA also changed how we take over-the-counter medication, due to a series of murders that took place in Chicago in 1982. Seven people in the Chicago area died suddenly and unexpectedly. Authorities traced the deaths to Tylenol capsules, which had been laced with cyanide. The perpetrator of the act was never caught. Soon after the incident, the FDA toughened product-tampering laws. In time, all over-the-counter capsules were replaced with today's familiar caplets.
Here are some of the main functions of the FDA:
It makes sure all ingredients used in foods are safe and that food is free of contaminants, including disease-causing organisms, chemicals, or other harmful substances.
It approves new food additives before they can be used.
It monitors the safety of dietary supplements and the content of infant formulas and medical foods.
It monitors medical products, making sure they are safe and effective before they can be used in the treatment of patients. These products include vaccines, gene therapy, as well as blood and biotechnology products.
The FDA regulates all medical devices, from very simple tongue depressors and thermometers to complex technologies such as heart pacemakers, kidney dialysis machines, microwave ovens, cell phones, X-ray equipment, lasers, medical ultrasound and MRI machines, and many other consumer, industrial, and medical products.
It monitors mammography facilities to make sure that their equipment is safe and they are properly run.
It regulates drugs and devices used on animals, both pets and livestock.
The FDA monitors cosmetic products to make sure that they are safe.
Most of FDA's budget goes toward paying its highly skilled work force. Its employees are drawn from science and public health professions, including biologists, chemists, physicians, biomedical engineers, pharmacologists, veterinarians, toxicologists, and specialists in public-health education and communication.
In order to carry out its mission, the FDA employs about 9,000 people who work in locations around the country. This network of field offices is generally the first point of contact for the public and regulated manufacturers. The employees in these offices focus on inspection and surveillance, laboratory work, and public and industry education.
The FDA staff that works in the Washington, D.C., office focuses on product review and regulatory policy.
ssential
To learn more about what the FDA does and why, check out its Web site, online at
New Product Review
The FDA reviews results of laboratory and animal and human clinical testing done by companies to determine if their products are safe and do what their makers claim.
The FDA does this for new human drugs, complex medical devices, food and color additives, and animal drugs. The FDA then tracks the product to make sure the manufacturers continue to maintain their standards of production and monitors cases of adverse side effects. FDA employees make more than 16,000 visits a year to facilities that make FDA-regulated products.
Research
The FDA's research provides the scientific basis for its regulatory decisions and the tools needed to identify risks. The agency uses its research results to guide standard setting, evaluate new products, develop test methods and other support for product monitoring, and to study emerging risks.
Enforcement
When problems arise, the FDA takes numerous actions to protect the public health. It works with manufacturers to correct the problem voluntarily. Failing this, legal remedies may be necessary, including impelling the manufacturer to recall a product, having federal marshals seize products if a voluntary recall is not implemented, and confiscating imported products at the port of entry.
FDA Career Opportunities
Employees are usually hired into the federal government under a career-conditional appointment. This means that the employee must complete three years of substantially continuous service before becoming a full-career employee. This three-year period is used to determine whether the government is willing and able to offer the employee a lifetime career, which is called tenure. Once you have tenure, it is next to impossible to lose your job.
The first year of service is considered a probationary period. The probationary period is really the final and most important step in the testing process that begins when an employee first fills out an application. This year gives the supervisor an opportunity to evaluate the employee's performance on the job. Previous federal civilian service counts toward completion of probation if it is in the same agency, the same line of work, and without a break in service.
At the FDA, three years of continuous service must not include any breaks of more than thirty calendar days. If an employee does not complete the three-year period or has a single break in service of more than thirty calendar days, he or she will be required to serve a new three-year period. Career-conditional employees automatically become full-career employees upon completion of these requirements.
