The FDA has reported that it will now be putting just as much effort into the monitoring of drugs after they have been approved as they do during the pre-approval process. A report labeled “Advances in the FDA’s Safety Program for Marketed Drugs” goes on to describe a range of new scientific tools that will be used to ensure that aftermarket drug monitoring would be just as important as the premarketing monitoring.

Various Changes Have Been Implemented

The amount of drug safety information and notices issued during 2011 (68) was almost double that which were issued during 2010 (39). Starting in 2008, the FDA required manufacturers to use a range of Risk Evaluation and Mitigation Strategies (REMS) to ensure that the benefits of any prescribed drug outweigh any risks that it may pose to users. The year 2008 also saw the FDA requiring companies to do numerous post-market studies and change labels based on new safety information.

Congress Steps In

A report issued in 2006 by the Institute of Medicine concluded that the FDA needed to do more in order to monitor the safety and effectiveness of medications after they had reached the market. Congress then got involved and gave the FDA permission to request that a company either conduct additional safety trials or change safety labeling on medication as required. Read more…