Through the Prescription Drug User Fee Act, enacted in 1992 and most recently renewed in 2012, the U.S. Food and Drug Administration can collect user fees from pharmaceutical and biological product manufacturers to help expedite the drug approval process. However, the number of black-box warnings and market withdrawals have increased following the passage of the legislation, according to a study in Health Affairs.
PDUFA gets drugs to market quicker, though is associated with higher rates of patient safety issues. The timeframe for approving new molecular entities — active ingredients never before marketed in the U.S. — shrunk 52 percent from pre-PDUFA to post-PDUFA approvals, from 33.6 months in 1979-1986 to 16.1 months in 1997-2002, according to the report.
However, a number of studies have found drugs that are more quickly reviewed by the FDA following the enactment of PDUFA are linked to higher rates of serious adverse drug reactions, according to the study. Researchers identified all new molecular entities approved by the FDA between the years 1975 and 2009 and then determined which were in drugs withdrawn from the market for safety reasons due to issues in the manufacturing or distribution phase potentially posing a public health risk.
They found an average of 26.7 out of 100 drugs were withdrawn following the enactment of PDUFA, compared to 21.2 out of 100 drugs before the enactment of PDUFA, an increase of 26.5 percent, according to the study.
Additionally, researchers found half of the new black-box warnings took up to 12 years to reach the market, and half of the withdrawals took up to five years to be initiated. Researchers suggest the new deadlines outlined by PDUFA may be causing rushed approvals, failing to identify safety problems before the drug hits the market.
The researchers acknowledge that longer approval times increase the time patients have to wait to access new drugs, but also say such rushed approvals may not thoroughly examine such drugs and identify any drug risks, according to the report.
"We believe that the ultimate solution is stronger U.S. drug approval standards," the researchers conclude. "In the interim, with the rare exception of truly breakthrough therapies, [physicians] should preferentially prescribe drugs that have been on the market longer and hence have a more established track record of safety."
More articles on FDA approvals:
Only about 0.1% of mHealth apps are FDA-approved
FDA proposes exempting certain devices from premarket requirements
What the latest FDA guidance means for mHealth