Is Quicker Drug Testing Approval Process Allowing More Dangerous Drugs on the Market?
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.
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