FDA drug monitoring and reporting under scrutiny

The regulation of medications, both prescription and over-the-counter, is led by the United States Food and Drug Administration. The goal of the FDA’s programs is to ensure public health and safety by preventing defective drugs from either reaching the marketplace or from being further utilized if already being sold and taken. St. Louis citizens trust the FDA every day to be their eyes and ears and prevent harmful drugs from being on the market.

A recently published article discusses the FDA’s process for monitoring drugs and alerting the public about a drug recall. It is rare that the FDA actually issues or requires a recall of any drug. Rather, the safety regulation of pharmaceuticals works by notification to the manufacturer of an identified problem. At that point, any recall issued is done so at the discretion of the pharmaceutical company and is voluntary.

There is no process in place that requires drug makers to notify doctors, pharmacies or patients about recalls when they take place. Instead, the FDA maintains a website where it posts lists on a weekly basis identifying the latest recalled medications. The article states that the website is difficult to find and unknown by most people in the country. It also points out the delay by what can be up to a week of new postings if a recall is made just after that weeks’ list has been posted.

A drug injury can result in anything from unpleasant side effects to wrongful death. No matter what end of the spectrum a reaction is on, it should be taken seriously. If you believe that you have been affected in some way by a defective drug or drug interaction, seeking professional counsel may be in your best interest.

Source: Huffington Post, “When your medicine makes you sick,” Spencer Aronfeld, August 8, 2013