Under Trumps Possible FDA Chief Developing Drugs Might Just get Way Cheaper

If this guy implements this change that $1 billion dollars and 10 year time frame to bring a drug to market just got way cheaper.

The first potential FDA chief appointee leaked by the Trump transition team is Jim O’Neill. Managing director of Peter Thiel’s Mithril Capital, O’Neill has publicly supported proposals to do away with the FDA’s requirement for phase 2 and 3 trials. Instead, he favors “progressive approval” of drugs and other medical technologies.

This will open a whole lot of innovation since the only bar they will have to pass is safety. Make sure the drug doesn't kill or maim the patient and then let it rip. The plan calls for a Phase 4 where the company must study efficacy data once the drug is on the market. This is a kind of "testing in production" model but it will get drugs to market faster than the 10 years it takes normally. When you take something breakthrough to market much faster it will strait-up save/extend lives.

The other thing it would do is break some of the stranglehold big pharma has on prices. If a company doesn't need $1 billion and 10 years to bring a biologic to market then they don't have to do profit sharing deals or whatever with big pharma. That argument that they have to charge so much because it took so much capital to develop would be moot. That big moat for big pharma will get smaller.

It will also allow targeted therapies to come to market. A company doesn't need to have a huge addressable patient population in order to make a drug. They just need to make sure it helps patients and extends there lives. So a drug for instance for Duchenne muscular dystrophy doesn't need to take years to develop and have a bunch of people afflicted with it plead with the FDA for approval. They could have had a few of them on the market and the FDA would have stopped the sales of the ones that didn't help those kids move around better.

Finally, drug prices should be put in check since you won't need $1 billion and 10 years to bring anything to market. Having ongoing efficacy studies sounds expensive though. However it won't be anything like moving something from breakthrough to approval nowadays. So overall we would get more therapies and cheaper prices but the drug companies would have lower margins. Sounds like a win for many parts of the industry and especially for the patient.