An analysis of US drug approvals suggests that expedited drug development pathways are working, but asks whether post-marketing review is keeping pace.

The lowdown: Clinicians, drug developers, politicians, investors, patients and regulators all have an interest in accelerating drug development, and have been working hard to introduce new pathways and policies that can speed up the process. Just last month, the US Food and Drug Administration (FDA) approved the first breakthrough drug candidate (see page 891). A JAMA Internal Medicine article now quantifies some of the benefits of the multitude of expedited drug pathways.

To compare expedited and standard drug development programmes, Thomas Moore, of the Institute for Safe Medication Practices in Virginia, USA, and a colleague analysed data from 20 drugs approved in 2008. They used the Freedom of Information Act to get data on when human testing began for each drug, and various other sources for data on clinical trial programme sizes and post-marketing requirements. Eight drugs approved in 2008 via expedited pathways spent an average of 5.1 years (varying from 1.6 to 10.6 years) in the clinic, compared with 7.5 years (4.7 to 19.4 years) for those that followed a standard route. The expedited drugs were tested in significantly fewer subjects: 104 (23–599 patients) versus 580 (75–1,207). The FDA has said that these findings show the expedited programmes are working as intended.

The paper also found, however, that 5 years after approval only 26 out of 85 (31%) of the post-marketing study commitments for these 20 drugs had been fulfilled. This points to “emerging troubles in the regulation of pharmaceuticals”, writes Daniel Carpenter, of Harvard University, in a linked commentary article. “It is concerning that the FDA may alter the terms of the implicit approval contract with pharmaceutical manufacturers, that is, less clinical testing of drugs before approval with quicker review in exchange for more reliable and rigorous post-approval testing, and not enforce the post-approval requirements as it should,” he writes.