The Declining Standards of FDA Drug Approvals

Maryanne Demasi

The US Food and Drug Administration (FDA) has a legal obligation to protect the public and ensure that the benefits of medicines outweigh the harms before being marketed to people.

But the agency’s increasing reliance on pharmaceutical industry money has seen the FDA’s evidentiary standards for drug approvals significantly decline.

… Industry fees were meant to speed up drug approvals – and they did. In 1988, only 4% of new drugs introduced onto the global market were approved first by the FDA, but that rose to 66% by 1998 after its funding structure changed.

… Consequently, faster approvals have resulted in new drugs that are more likely to be withdrawn for safety reasons, more likely to carry a subsequent black-box warning, and more likely to have one or more dosages voluntarily discontinued by the manufacturer.

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