The Food and Drug Administration works to ensure drug safety and effectiveness.
The United States Food And Drug Administration regulates and monitors the nation's drug supply for trials, safety, effectiveness and advertising. Established in the early 20th century, the FDA's mission was to rein in dubious and often times dangerous concoctions sold as medicine to cure most ailments. In the following century the FDA has established criteria for drug manufacturers to follow for clinical trials to determine a drug's effects and side effects on patients. The FDA also monitors a drug's safe application in the marketplace and whether the drug continues to effectively treat various conditions over time. Finally, the FDA has approval over drug advertising and marketing to ensure accurate information is provided to consumers and health care professionals.
Trials
When a manufacturer produces a new drug it will submit an application to the FDA to begin clinical trials. These are controlled prescription of new drugs supplied to patients to determine if the drug has its anticipated effects on a wide range of clinic participants and also to determine any unanticipated side effects. The FDA will review the application to ensure all development, manufacturing and pre-clinical testing is thorough and complete.
If the application is approved, the manufacturer will work closely with the FDA and participating health care providers to administer the drug to patients. Constant monitoring and reporting of results to the FDA will allow the manufacturer to provide for the safety of the patients using a new drug while at the same time provide opportunities for review. During the clinical trials the FDA may order a halt at any time based on the results submitted. If the trials are successful over a given time (months or years), then a license to produce the drug is provided to the manufacturer.
Safety
The FDA monitors and inspects manufacturing processes, distribution and administering of the drugs. Matters relating to quality standards, chemical formulas, sanitary conditions and batch testing all factor into the manufacturer retaining the license to continue production. The FDA has the legal standing to halt production and distribution at any time if a manufacturer or health care provider is found to operate outside the requirements established in the manufacturing license.
Advertising
The FDA can control the message manufacturers put out to the public and the health care industry. Issues such as accuracy, stated claims, clinical results and substantial side effects can affect how a drug is advertised or marketed. The FDA can halt advertising campaigns found to be misleading or not fully disclosing all necessary information. The FDA can also review and add or subtract information from pending advertising efforts in order to ensure full disclosure to doctors and their patients.
Tags: health care, clinical trials, side effects, determine drug, Drug Administration
