The FDA is a government agency responsible for protecting the health of consumers by regulating numerous products emerging onto the market. Although many of these products include new drugs and treatments, other examples include veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation. Products the FDA does not regulate include water, alcohol, pesticides, health insurance, advertising, and consumer products. Each product division has their own regulation process, with the drug sector being most rigorous. The main watchdog in this process is the Center for Drug Evaluation and Research (CDER). The CDER ensures that drugs generic and brand name drugs work productively and that their health benefits outweigh any risks.
According to the FDA, "drug companies seeking to sell a drug in the United States must first test it. The company then sends CDER the evidence from these tests to prove the drug is safe and effective for its intended use. A team of CDER physicians, statisticians, chemists, pharmacologists, and other scientists reviews the company's data and proposed labeling. If this independent and unbiased review establishes that a drug's health benefits outweigh its known risks, the drug is approved for sale. The center doesn't actually test drugs itself, although it does conduct limited research in the areas of drug quality, safety, and effectiveness standards. Before a drug can be tested in people, the drug company or sponsor performs laboratory and animal tests to discover how the drug works and whether it's likely to be safe and work well in humans. Next, a series of tests in people is begun to determine whether the drug is safe when used to treat a disease and whether it provides a real health benefit."
Notice: DrugRecalls.com is an independent consumer resource providing information and legal claims assistance to persons injured by recalled or unsafe drugs. DrugRecalls is not affiliated with the FDA or any other government agency.
FDA Prepares to Enact New Food-Safety Law
In the last week of 2010, Congress approved a new food-safety bill that is to be signed into effect by Obama. Over the next five years Congress will need to appropriate an additional $1.4 billion for the FDA to fully implement the bill.
According to Health and Human Services Secretary Kathleen Sebelius, "today, one out of six Americans gets sick from food-bourn illness each year with 128,000 people ending up in the hospital and 3,000 people dying every year." The law currently only gives the FDA permission to request that companies conduct a recall, but with the new laws in effect, the FDA will have a new authority that allows them to mandate food recalls. With proponents arguing that this will accelerate the process of getting bad food products off of grocery store shelves, opponents state that the FDA already has enough leverage within the food-industry and needs to simply spend additional money to send more inspection personnel to farms and food production facilities.
A study by the Pew Charitable Trusts estimates that food-borne illnesses such as salmonella and E. coli cost $152 billion in health care costs annually. Thus far, the FDA has been given several million dollars to begin writing and enacting new food safety provisions, states the Wall Street Journal.