A recent US medical proposal that is likely to become law this year, will allow for the fast tracking of breakthrough drugs that exhibit successful early results in patients with serious or life-threatening diseases. According to the proposal, breakthrough drugs usually take longer to approve, however the new law could give the US public faster and cheaper access to effective therapies.
According to the proposal, US drug regulators would be able to label such drugs as ‘breakthrough’ therapies and could then partner with pharmaceutical companies and those centrally involved with clinical jobs to shorten the length of clinical trials. This would be done by either testing the breakthrough drugs over a shorter period of time or by having fewer patients participating in the clinical trials.
The proposal has received much support from leading medical organisations and companies, such as the US Food and Drug Administration (FDA). It also coincides with President Barack Obama’s objective of fostering innovation to create more job opportunities, thereby reducing unemployment. The FDA currently has many critics who state that the US is far behind European countries in approving new breakthrough drugs and technologies.
If the law is passed, which is likely to be the case, the FDA will have more flexibility in approving new drugs that show unexpected quick success in helping trial patients. This type of system has had success in the past, for example during the fast tracking of the HIV Aids drugs breakthrough in the 90s. When the proposal is approved, more effective breakthrough drugs can be created and higher employment in clinical roles, such as pharmacovigilance consultant jobs, can be achieved.