Newly-approved drugs have one in three chance of black box warning or withdrawal

Newly-approved drugs have a one in three chance of acquiring a black box warning, or being withdrawn for safety reasons within 25 years of being approved, according to a new study conducted by several East Coast academic institutions and Public Citizen.

Researchers from Cambridge Health Alliance, Harvard Medical School, Boston University School of Medicine, City University of New York School of Public Health and Public Citizen have published their study in the August issue of Health Affairs, and have studied all drugs approved by the US Food and Drug Administration over a 35-year period.

The study looked at warning and withdrawal rates for drugs released pre- and post-1992, when the approval process for medications changed with the Prescription Drug User Fee Act, allowing the FDA to collect fees to expedite drug approvals. Since the PDUFA came in, the average drug approval time has fallen from 34 months to 16.