IOM Recommends FDA Adopt New Drug Safety Measures
07-10-2012
When is it appropriate to require a post-marketing study on the safety of a drug? How can studies be used in making regulatory decisions? What measures best protect the rights and interests of patients participating in the research?
To answer these queries, the U.S. Food and Drug Administration (FDA) commissioned the Institute of Medicine (IOM) to review the scientific and ethical aspects of safety studies for approved drugs. IOM’s recommendations are outlined in its “Ethical and Scientific Issues in Studying the Safety of Approved Drugs” report.
Currently, FDA checks for new safety issues after a drug has been on the market for 18 months and used by 10,000 patients. But now variations in federal laws are giving FDA a chance to ramp up its safety systems and their effectiveness on the market. But with these changes comes questions – and challenges.
Among its endorsements, IOM calls for the FDA to review drugs on a regular basis for as long as they are on the market. The IOM sees this as a continuous process that starts immediately after a drug has been approved. It’s what IOM calls a “life cycle approach.” This approach “places substantial emphasis on drug safety after the FDA approves a medicine for sale, and requires that the FDA anticipate and plan well in advance how it will monitor a drug’s safety over its market lifetime.”
To that end, IOM suggests FDA create a publicly available, easy-to-understand Benefit and Risk Assessment Management Plan (BRAMP) as a method of identifying profits and threats throughout the lifecycle of a drug. Although, with its current resources, FDA has reservations about the costs posed in implementing the plan.
According to the Centers for Disease Control and Prevention (CDC), 48 percent of Americans take at least one prescription drug daily. Measuring and documenting the effects of all these drugs on Americans is a daunting task and the science-based nature of the supporting research is anything but easy-to-understand. But the IOM is calling on FDA to step up to these challenges by making their current system exhaustive, transparent and predictable to support the ever-changing regulatory landscape.
What do you think of the IOM’s recommendations? Do you think this approach is feasible? Please share your thoughts with us below.
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