FDA access programmes shaved up to a year off drug approval times, new study shows

A research letter published this week has suggested that the FDA initiatives to accelerate drug approvals in the US could have shaved up to almost a year off the regulatory process.

A trio of health economists from Boston’s Brigham and Women's Hospital found that 105 of the 174 biologic therapies approved between January 2012 and December 2016 were put through one of four accelerated paths and reached market within 5.1 to 10.1 years, with a midpoint of 7.1 years. By contrast, the remaining 69 therapies which followed the standard pathway covered the same ground in 6.5 to 10 years, with a midpoint of eight years.

Accelerating approval of drugs became one of President Trump’s many big promises during his campaign, and his term has so far seen the appointment of FDA Commissioner Scott Gottlieb, who has singled this out as one of his primary remits. However, the research shows that two programmes were most responsible for these shortened approval times, and both predate any of these discussions by a number of years.

The first, instituted in 2012, was the "breakthrough" designation assigned to promising therapies. Drugs given this designation saw their clinical trials and evaluation process streamlined and more FDA personnel dedicated to them, resulting in half of nominated treatments scoring approval in 4.8 years or less, compared to a median eight years for those in the standard lane.

The second was the FDA’s 1997 "fast track" programme, which works in a similar, though less extensive, vein. This process saw relevant drug approval times shortened by around a year from the median development time.

The report also claims that the FDA’s Accelerated Approval and Priority Review programmes, both initiated in 1992, had little to no effect on shortening drug approval times.