The U.S. Food and Drug Administration (FDA) is an agency of the United States Department of Health and Human Services, that is responsible for making sure that the drugs, pharmaceuticals and medical devices used by the public are safe. As noted on the FDA’s own website:
FDA is also responsible for advancing the public health by helping to speed innovations that make medicines more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medicines and foods to maintain and improve their health. FDA also has responsibility for regulating the manufacturing, marketing and distribution of tobacco products to protect the public health and to reduce tobacco use by minors.
Unfortunately, every year thousands of Americans are either killed or injured by drugs and medical devices that are approved by the FDA. A recent Institute of Medicine study concluded that there are major deficiencies in the FDA for ensuring safety including but not limited to a bias in approval process and inadequate regulation.
Common complaints against the FDA are that the agency has been slow to inform the public and pull drugs that are known to be dangerous. Most recently, the popular cases of Vioxx and Rezulin are key examples that support such complaints. Rezulin, a drug sued to treat diabetic patients was pulled off the market in the UK in 1997. Post-market studies showed the dangers of liver failure and other adverse reactions killing thousands of people. It wasn’t until 2000 that the FDA finally took the drug off the market in the US. Vioxx was manufactured by Merck & Co. and was voluntarily taken off the market in 2004 after thousands of patients using the drug suffered serious cardiovascular problems or were killed. Later investigations showed that efficacy studies were fabricated by the manufacturer and that Merck & Co., withheld information from doctors and patients regarding its dangers.
Today, pharmaceutical companies spend billions of dollars marketing their drugs and medical devices. It is only with a proper system of check and balances that the public can truly be protected. By sharing information and knowledge, we can work together to help build a safer future.
