FDA clinical trials

In the past months we’ve seen the approval of several drugs with limited data. Possibly this is the ‘natural’ consequence of both the Fast Track Designation and the Adaptative Pathway solutions that have been accepted.

Though there is clear benefit in accelerating promising developments, we should not overlook two major issues: first, HTA bodies and the administrations they represent are not convinced with this looser approach, not to say some of the national Drug Agencies that are not willing to deal with provisional data; second, and most important, we may now start asking FDA and EMA why did they approve development plans everyone knew would not be accepted for access purposes.

It has been argued that HTA bodies delayed access to medicines. We may discuss to which extent this is true, but should also be discussed is the frustration and economic loses a flawed albeit accepted development programme inflicts to manufacturers.