Maryland Injury Lawyer Blog

On Texas lawyer Bob Kraft's blog, he writes a blog on a common theme (click, for example, here and here) discussed on the Maryland Personal Injury Lawyer Blog: that the FDA should do more and the mere fact that the FDA approved a drug should be of little significance in a product liability case involving a pharmaceutical drug. As to the former point, Bob points to a New York Times article last week that discusses an Institute of Medicine (IOM) recommendation on what changes need to be made at and with the FDA. The IOM report suggestions included:

Newly approved drugs should display a black triangle on their labels for two-years to warn that as a new drug, their safety profile has not been established;

Drug advertisements should be limited during this two year period;

The FDA should thoroughly review the safety of drugs at least once every five years;

The FDA should have the power to issue fines, injunctions and withdrawals when drug makers fail — as they often do — to complete required safety studies;

Drug makers should be required to post publicly the results of nearly all human drug trials.

The IOM carries real weight in government and heath care circles. Let's see what happens with these recommendations.