News & Resources

November 2, 2009. Category: Product Liability, Unsafe Drugs, Unsafe Medical Devices

The FDA Must Improve Communication to Patients

The American Recovery and Reinvestment Act allocated $1.1 billion dollars to coordinate research and guide investments in comparative research funded by the Act. Some critics suggest that a whole lot of money could have been saved just by looking to the FDA.

Dr. Lisa Schwartz and Dr. Steven Woloshin have co-authored a New England Journal of Medicine article titled "Lost in Transmission – FDA Drug Information That Never Reaches Clinicians" in which they talk about the fallacies of the current system, and possible ways to correct it.  Primarily, on the journey from clinical trials to FDA approval to the production of a drug label, potentially vital information is lost.  For example, the FDA approved the drug Rozerem in 2005 to treat chronic insomnia, but in one phase 3 clinical trial, the drug failed to provide any benefit at all for this condition.   In fact, a memo created by the FDA’s own medical review team debated whether to even approve the drug since the insignificant benefits provided by the drug may be outweighed by its potential side effects, but Rozerem was eventually approved.  Obviously, knowing this background information would certainly appear to have an effect on a doctor’s enthusiasm to prescribe the drug, and a patient’s willingness to take the drug. Unfortunately, though, this type of important information is not placed on the FDA’s approved drug label, so none of it is clearly communicated to the public.

To its credit, the FDA has issued new guidelines about drug labeling, such as including phase 3 trial results and other effectiveness data, but this information is not mandated as it should be.  In the case of Rozerem, the effectiveness data is still absent even after the label was updated. Bottom line - more needs to be done.

The FDA is currently undergoing a pilot test of a “drug fact boxes” which would include a succinct table of effectiveness data such as reviews and labels. This would give doctors more pertinent information about drugs and also allow patients to make a more educated decision before they take a new medication. The FDA is still debating internally how to use these “drug fact boxes.”

There are other potential alternatives, but the authors concisely (and correctly) conclude, “Whatever approach the agency adopts, it needs a better way of communicating drug information to clinicians. We don’t need to wait for new comparative-effectiveness results in order to improve practice. We need to better disseminate what is already known.”


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