Drug discovery is a time-consuming process in any country – trials that follow the proper rules of Good Clinical Practice take a lot of time and money. And that is before you consider the frustrating wait for approval from the official agencies.
A solution adopted in the US was the 1992 Prescription Drug User Fee Act (PDUFA), which made the company developing a drug pay a fee to the FDA to fund its approval. This provided the additional funds needed for the FDA to increase resources and make approvals faster. Everyone was happy.
After all, US pharma companies pay for Independent Review Boards (IRB) ethical approval of trials – why is this any different?
I’ve already posed the question about whether an IRB can be truly independent if it is in the pay of the company designing the trial.
The same applies to the FDA – especially following a report published on 15th August that puts the total fees paid under the PDUFA at an eye-watering $7.67 billion (£5.84 billion). So it’s a pretty lucrative business.
Some have even accused the FDA of being “in the industry’s pocket.”
In my opinion, the key difference between the situation with the FDA and IRBs is the lack of competition. If a drug company wants to register a drug in the US, it can’t shop around for the agency it likes to work with.
The report claims that some of the money collected isn’t being spent where it should be – on making the approval and review process more effective. It cites $300 million in user fees that have not been spent – although this does mean that 96% of the money was spent.
The PDFUA will expire next year so it will be interesting to see if it gets renewed…