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US Drug Safety Tracking Insufficient, Says Study

By May 16, 2012July 15th, 2019Uncategorized

In addition to its role in verifying drug safety in pre-commercial trials, the FDA should play a role in regularly re-evaluating already approved medications to determine if new safety issues have cropped up over a drug’s lifetime, according to a new study by an independent review board.

The Institute of Medicine has suggested that every drug should be periodically reviewed the entire time it’s on the market, so as to better keep consumers aware of additional safety issues that crop up over a drug’s marketable lifetime. This information should ideally be included in several sources, according to the study. This could include product packaging, but primarily is intended to be placed in a centralized, easily accessible document or database that receives periodic updates about drug safety issues. Ideally, this document would be easy for consumers to access and examine when they have questions about a drug and its potential effects.

The FDA is in no way bound by the IoM’s recommendations — the IoM is not a governing body. The FDA acknowledged the merits of the idea, but expressed reservations about the cost. Medical testing is already an expensive proposition for the FDA to oversee, and adding additional long-term oversight to the matter could cause the Administration to require extensive funding increases.

Currently, the FDA is only required to evaluate a drug’s safety issues at one of two points — when the drug has been prescribe to at least 10,000 patients, or 18 months after the drug goes to market, whichever is later. Further, the FDA relies on side effect reports from the drug makers themselves, or from patients who have been taking the medication. The conflict of interest in the former case is obvious. Patients, particularly those on multiple medications or a new medication for the first time, can often have trouble distinguishing between side effects and whether they should report them. From a safety standpoint, expanded oversight cannot be a bad thing in such a case.