Drug Approval Times and User Fees

Abstract

On the surface it would seem that everyone — industry, patients and regulators — would be in favour of faster drug approvals. Approval times in developed countries vary significantly. One major cause of slow approval times is resource availability. In the face of government reluctance to increase funding to regulatory agencies through tax dollars, user fees (payments from industry) have been adopted in many countries. In the US, user fees were accompanied by a commitment to faster approvals, whereas in other countries there seems to have been a tacit agreement between industry and the regulator that approval times would become shorter. Information from the US, Australia and Canada shows that user fees have resulted in more rapid drug approvals and a greater percentage of new drug applications being approved. To the extent that new drugs improve health outcomes, patients have benefited, and there is some contested evidence that an increase in the use of new drugs leads to better health but the large majority of new drugs do not offer any significant therapeutic gains. At the same time as improving drug approval times, user fees have also resulted in the shunting of agency resources into the approval system and away from other regulatory functions, such as postmarketing surveillance. Furthermore, for the US Food and Drug Administration, the introduction of user fees also seems to have led to increased workloads for agency staff and lower staff moral. There is a major ongoing debate about whether or not faster approvals subsequently lead to more drug withdrawals for safety reasons. There is a body of evidence that seems to indicate that this is not the case but other metrics, such as the fate of drugs that are approved just prior to legislated deadlines, show higher rates of withdrawals for this group of drugs. Finally, many prominent doctors and academics believe that user fees have fundamentally changed the relationship between regulators, the public and industry, and there are calls in the US for the abolition of user fees.