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Monheit Law : Blog Home : 2005-04-06 : Article

FDA Drug safety steps -- is its safety board enough?

The FDA created a Drug Safety Oversigth Board. Is this enough? While it is certinaly a step int he right direction, it may only be a baby step.


Given that the FDA is a very political body, there are serious problems, and its reputation has suffered. These problems arise from conflicts of interest. On one hand there is post marketing to make sure drugs that are on the market are safe. On the otherhand, there is pressure to get new drugs approved and not to pull something already approved. Having the same authority responsible for both creates a conflict.


In addition, the safety board is merely advisory. They can not pull a drug from the market. Worse yet, the board is comprised of the same people who made a mistake in approving a drug, and are now being asked to remove that drug. The board is also stacked iwth people who have industry ties.


However, even when a drug is still on the market, a finding by the board that there is an association with a drug and a problem will be strong evidence in court.