e Act expanded the FDA's authority to cover serums and vaccines and also justified the inspections of restaurants (Food and Drug Administration [Britannica]). The FDA is adjusting to a switch in leader ship since Jane Heney, previously the FDA's deputy commissioner of operations, was nominated in June 1998. Heney, the first woman to head the FDA, has a packed resume that includes a vice presidency of the University of New Mexico and a specialization in cancer research. Her strategy for the future of the FDA includes the enforcement of new federal laws to modernize the FDA and addressing concerns about drug safety and approval speed, as well as controlling food contamination (Davis 5D).The FDA requires pharmaceutical companies to conduct years of research on their drugs before they begin the actual process approval. Drug companies submit test results to the FDA to be reviewed by their scientists; the FDA actually does no preliminary research on the drugs. In order to be approved, the companies must prove to the FDA that each drug is safe and effective and that the benefits of the drug must outweigh its side effects. The FDA has 800 to 900 employees involved in reviewing drugs before they get to the market. After a drug is approved, the FDA researches by collecting and analyzing thousands of reports each year. Large teams of investigators review drugs to see if any may need to be withdrawn from the market by looking for unexpected and adverse reactions (An Overview 2). The entire procedure of research to which pharmaceutical companies must subject their drugs consists of three phases. In the Pre-Clinical Stage, companies must screen their synthetic chemicals for potential use by performing studies in test tubes and with animals. After around two years of testing, companies usually file an Investigational New Drug Application (IND) with the FDA. Next, in the Clinical Stage, drug companies spend around eight years conducting stu...
