Are we test guinea pigs for prescription drug ?

After a drug has been on the market for 18 months and used by 10,000 patients, the FDA (Food and Drug Administration) checks for new safety issues.  Now, new variations in federal laws are giving FDA a chance to “ramp up” it’s safety systems and their effectiveness on the market.

The FDA commissioned the IOM (Institute of Medicine) to review the scientific and ethical aspects of safety studies for approved drugs.  Some aspects of the safety studies include:

• 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?

The IOM is calling for the FDA to review drugs on a regular basis starting immediately after a drug has been approved, and continuing for as long as it is on the market.  This process is called the “life cycle approach” , it “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.”

The FDA has reservations about the cost in implementing the “life cycle approach” plan.  According to the CDC (Center for Disease Control and Prevention) 48% of Americans take at least one prescription drug a day, making the plan seem like a daunting task when it comes to measuring and documenting the effects of all drugs on Americans.  The IOM is calling for the FDA to “step up” to the challenges.