Black box warnings and drug market withdrawals, by the numbers
On Tuesday, BioPharma Dive reported on a Health Affairs study finding that, since the passage of the Prescription Drug User Fee Act (PDUFA) in 1992, the number of FDA-approved drugs that are eventually withdrawn from the market or given a black box warning has risen sharply. That coincides with faster drug approval times, a rising number of drugs approved in a given year -- and the FDA's dependence on pharmaceutical industry fees to fund various parts of its budget.
Factors such as the authorization and increasing use of post-approval studies to determine drug safety likely contributes to this trend, as the British Medical Journal notes. But the correlation is striking -- and one that researchers are certain to keep their eyes on in the coming years.