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More than a quarter of the drugs approved by the FDA after 1992, received the black box warning or were withdrawn, which is 5 percent more than is the case with drugs approved before 1992. This is concluded by researches of several institutions, including Cambridge, Harvard en Boston in a publication in Health Affairs.

PDUFA
The scientists compared drugs over a period of 35 years, approved by the FDA before and after 1992. In 1992, the approval process for drugs changed with the acceptance of the Prescription Drug User Fee Act (PDUFA). With the PDUFA the FDA can receive a fee from drug manufacturers when a New Drug Application (NDA) or Biologics License Application (BLA) is submitted. As a consequence, the approval process speeds up. Since the acceptance of the law, the average time needed for the process is cut in half from 34 to 16 months.

Black box label
Of the approved drugs after 1992, 26,7 percent received a black box warning or was withdrawn due to safety concerns. This was the case with 21,2 percent of the drugs being approved before 1992. A black box warning is the strongest warning the FDA can issue. The warning is required when it turns out that the drug carries a significant risk of serious or even life-threatening adverse effects.  

According to the scientists, this increase could be caused by the PDUFA. Because of the constant pressure put on the FDA to approve or decline new drugs “more dangerous drugs are slipping through”, they say. In addition, the increased FDA authority to demand further studies after approval plays also a part in this, the scientist suggest. This is now done more often afterwards, instead off prior to the approval.

Withdrawn
Of the 32 withdrawn drugs, approved after 1992, only a few showed new advantages in comparison to the older kind. Withdrawal happened until 30 years after approval.

Source: MedicalXpress