What Is A Drug Manufacturer’s Responsibility?

Drug companies are required to conduct testing before the Food and Drug Administration (FDA) will approve a product and allow it to be marketed in the United States. Unfortunately, there is less accountability once the product is on the market. For the risks that can’t be premarket tested, such as birth defects due to the potential danger to unborn children, drug companies have a responsibility to continue research on their product once user data emerges.

Drug companies can collect data and analyze it for trends of adverse side effects. If negative data surfaces, notification must be given to the FDA, doctors and patients. In extreme instances, a drug will require a black box warning (the severest warning the FDA can give) or will have to be recalled from the market.

Most medical devices must go through rigorous testing before the FDA allows them to be released onto the market. However, some devices can be marketed through the FDA’s controversial 510(k) program. This premarket notification system allows a medical device manufacturer to submit a product to the FDA, and, if it is shown to be similar enough to a currently sold product, it is cleared without the required FDA testing. This procedure can leave some devices not properly tested.

On some occasions, medical devices are fully tested before being released on the market. Often these products improve the lives of many people. However, if adverse side effects begin to emerge, the device manufacturer has a duty to conduct research, in the form of further testing and/or by analyzing patient data. If research indicates a problem with the device, the company should notify the FDA, doctors and consumers, and then take steps to fix the device or recall it from the market. Obviously, these measures could negatively impact the company’s sales, which causes some drug and device manufacturers to hide unfavorable research results.