Doing what I do here, I always get the impression that many people think that Big Pharma drug development is relatively easy. Just invent a drug, test it on some people, and then call up the FDA to get approval to sell it. I know that supplement manufacturers would be so happy if they could do that.
The actual facts are that Big Pharma drug development is so expensive, complicated, time-consuming, and failure-prone that you have got to wonder why anyone would jump into this process. For some drug discoveries, people grow old waiting for final FDA approval.
The myths about Big Pharma drug development are filled with controversy, false claims, and conspiracy theories. Yes, occasionally, we can point out problems with the process. Unless you’re using confirmation bias, you will see that the vast majority of pharmaceuticals are very safe and very effective (or at least the benefits outweigh the risks).
One of the largest myths is that there really isn’t any regulation – Big Pharma owns the FDA (and other regulatory agencies) and does whatever it wants. But let’s look at the process of Big Pharma drug development carefully, including how most drugs are investigated and brought to the market. Let’s try to separate the myths from the facts about Big Pharma drug development.
I have written a similar article about vaccine development, but I wanted to have one that was more about all drugs, except vaccines. Vaccines, and other biological drugs, have slightly different development and regulatory pathways which are not used to bring a standard pharmaceutical to market.Continue reading “Big Pharma drug development — it’s not as easy as everyone thinks it is”