Study finds no link between drug safety and US approval speed
Tufts CSDD director Kenneth Kaitin says the study failed to establish a link between FDA approval times and drug safety.
By on Oct 12, 2005Tufts CSDD director Kenneth Kaitin says the study failed to establish a link between FDA approval times and drug safety.
Kaitin says the group wanted to investigate, given the rising public concern over drug safety, whether assertions by FDA critics that drug safety in the US has deteriorated since the adoption of user fees in 1993 were valid.
The Prescription Drug User Fee Act (PDUFA), passed in 1992, authorized the FDA to collect fees from drug companies to be used, in part, to hire additional reviewers and improve the drug review process. The PDUFA was reauthorized in 1997 and again in 2002.
To date, we have found no evidence that links the rate of drug safety withdrawals and the passage of legislation more than a dozen years ago aimed at speeding new drug approvals, he says. In fact, since 2000, the rate of safety withdrawals in the US has dropped.
According to Tufts CSDD, 3.2% of all drugs approved for sale in the US in the 1980s were subsequently withdrawn. That rate increased slightly to 3.5% during the 1990s and has dropped to 1.6% since then.
And, according to Tufts's data, longer approval times do not assure greater safety. The average approval time of 2.14 years for drugs withdrawn since 1980 compares to 2.08 years for approvals during that time. And the group says faster approval times do not correlate with safety withdrawals within therapeutic classes.
Recent analysis by John Abraham and Courtney Davis at the Centre for Research in Health and Medicine at the University of Sussex examines why there were more than twice as many new prescription drugs withdrawn from the market on the grounds of safety in the UK as there were in the US between 1971 and 1992. The team concludes that the discrepancy is because US regulators applied more stringent pre-market review and/or standards, which took longer than UK regulatory checks, but prevented unsafe drugs marketed in the UK from entering the US market.
They say, however, that their results imply that it is likely that the acceleration of regulatory review times in the US and the UK since the early 1990s is compromising drug safety.
But does accelerated review necessarily equate to less stringent review? The whole idea behind PDUFA was to hire more reviewers to both speed and improve the process, not compromise it.
Tufts's data certainly seems to support the contention by the industry and the Agency that accelerated review times have not compromised drug safety.