The Prescription Drug User Free Act imposes deadlines for the completion of drug reviews by the Food and Drug Administration. This may affect the approvals by rushing them. A rushed approval may ignore unanticipated safety problems. Products superficially analyzed reach the market and this leads to consequences on people’s health.

In an article published in The New England Journal of Medicine it is said that “such criticism have been heightened by the safety-based withdrawals of rofecoxib (Vioxx, Merck) and valdecoxib (Bextra, Pfizer),  the delayed recognition of suicidality in children and young adults taking selective serotonin-reuptake inhibitors, and the addition of a black-box warning about congestive heart failure and controversy over the risk of myocardial infarction caused by rosiglitazone (Avandia, GlaxoSmithKline) 8 years after it was approved.”

A report suggests that FDA scientists perceive the PDUFA as having reduced the agency’s focus on drug risks.

Review times have probably been accelerated by other factors, such as the development of information technology or the submission of higher quality new drug applications.

An important issue, whether the deadlines imposed by the PDUFA legislation affected the pattern of FDA decision making, wasn’t taken into consideration.

Daniel Carpenter, professor of government in Harvard’s Faculty of Arts and Sciences initiated a research study to determine whether drugs fast-tracked by the FDA were more likely to be withdrawn for safety reasons, more likely to carry a subsequent black-box warning or to have one or more dosage forms voluntarily discontinued by the manufacturer.

The result of the research is that the discovery of safety problems is more likely for drugs approved immediately before a deadline than for those approved at other times.