A Single Scientific Safety Standard A Single Scientific Safety Standard
U.S. Food and Drug Administration

Welcome to Andy’s Take.

You may have recently purchased a drug at your pharmacy and I hope you looked at the package insert – and JUST how detailed the information is on the drug labeling. In creating that label, drug companies must fully comply with FDA regulations – including disclosing all appropriate safety information.

My Take is that no company should ever be allowed to withhold safety information the law requires them to disclose to the FDA. If companies illegally withhold adverse events, they should be punished. But FDA must have the final word as to what details are on the drug label – otherwise there is no standard and that creates chaos.

The FDA is the agency commissioned by law to set national standards for the safety and efficacy of the medical products you and your family use. In setting these national standards, the FDA requires that information on product labeling be based on a rigorous scientific process and provide clear guidance to you and to your health care provider.

To protect and promote your health, FDA review teams consisting of medical doctors, chemists, statisticians, microbiologists, pharmacologists, and other experts, determine exactly what medical product labels should – and should not – contain. The FDA strikes a careful balance that considers the importance of warning patients of potential dangers while at the same time not discouraging appropriate use of beneficial drugs through warnings that are excessive relative to the risk. Such inappropriate warnings would cause harm by diluting the significance of more meaningful and relevant information.

If actions beyond FDA improperly interfere with FDA’s labeling decisions, this would cause confusion for you and your health care provider regarding what is the expert information you need to make the best, most well-informed choices on whether to pursue particular therapies.

The bottom line is that the FDA is the public health agency charged by Congress with the responsibility to ensure that drugs and certain medical devices are safe and effective and that the labeling on those medical products – using a single scientific safety standard – adequately informs you and your physician of the risks and benefits of the product. The best way to assure you are adequately protected is to have a strong science-based and science-led FDA.