In 1992, Congress enacted the Prescription Drug User Fee Act. This act enabled the Food and Drug Administration (FDA) to accept fees from drug manufacturers when they submit a new drug for approval. In order to keep those fees, the FDA is required to keep on schedule during the testing process, which has resulted in a much quicker approval process than there was before the law was passed. But has that change caused more dangerous drugs to end up in patients’ medicine cabinets? That is the concern of many physicians after the results of a new study were published in the medical journal Health Affairs. Using data from the Tufts Center for Drug Development, researchers looked at the 748 medications which were approved by the FDA from 1975 to 2009 to find out how frequent there were safety problems with medications. What they found was that since 1992, one of four drugs that have gone through the process and have received the FDA’s seal of approval ended up either receiving a black box warning or being pulled off the market completely. A black box warning is the FDA’s most severe warning issued. A black box warning is put on all of a prescription medication’s packaging (including magazine advertisements) when the following apply:
- The medication has the potential of such serious side-effects that patients and/or physicians may feel the risks are not worth the benefits of the medication.
- The medication may be safe for one group, but can cause severe reactions in another.For example, the medication is safe for adults, but can be dangerous if given to a child.
Although the results of the study show an increase in the number of dangerous drugs approved since the changes in the FDA’s approval process, researchers could not say if it is the approval process or if FDA’s requirements of after-market drug testing companies are required to do is the cause of the increase, but recommended that more research be done. The research team also recommends that patients not use a new drug until it has been on the market for at least seven years. If you have suffered serious side-effects from a defective drug, contact an experienced New Braunfels personal injury attorney to find out what legal compensation you may be entitled to.