The problem is that regulation is so expensive there isn't any financial motivation in researching does that are unlikely to generate massive revenue.

The reason for this is FDA is fundamentally extremely conservative. The people that run the regulatory system are just faceless bureaucrats and are risk adverse. Their pay is based on seniority and there isn't any financial motivation for them to take risks or stand out. FDA is nothing more then a collection of individuals so the motivation of the agency is a mirror image of the motivations of the people running it.

To put it bluntly:

When diseases like cancer or influenza or <insert name of any disease> kill people the diseases get blamed. But if a drug makes to it market and ends up maiming people or killing them then the FDA gets blamed.

So from the FDA's perspective it's much more important that we have ultra-safe drugs then it is to have new drugs to cure and treat diseases.

The regulators are going to take the default position that more testing and screening and expenses are good. While allowing consumers and doctors to take risks to treat diseases is bad. And over the decades it has just gotten more and more and more and more expensive to get the drugs out to the public.

And since it's too expensive to make new drug companies because of the regulators then you will never see any smaller nimble companies come in and compete with them and force the big companies to behave themselves.

This is why you see all the generic drugs being bought up in the past couple decades. During the Obama administration they signed regulatory changes that rose the cost of validating generic drugs considerably. It wasn't so expensive that it would drive generics from the market, but it's expensive enough that you can't make new generic drug companies. So the big name brand drug companies just buys them all up. And because of that they no longer face competition from generics. They own both the name brands and the generics.

If it was cheaper to make generic drug companies this approach wouldn't work. People would make new companies for the sole purpose of getting bought. It would make buying companies up to kill competition unsustainable.

I've worked in heavily regulated industries before and it's a pretty obvious pattern. Regulators regulate. Costs go up. Competition goes down. And then the big companies become isolated from competition because it's just too expensive to compete with them. Then the government has to bend over backwards to ensure the profitability of these dominate corporations because if they were to go out of business there would never be any replacements.

It's a form of market lock-in. Over regulation effectively becomes a license for these big pharma companies to do pretty much whatever the fuck they want. They love it.

I think people who talk about "over regulation" should be excluded from serious discussion. "More" or "less" or "no" regulation is never the answer.

I don't think we have ultra safe drugs. I could be just paranoid, but I don't think the FDA is that good at monitoring the manufacturing of drugs. And I know I've read about how sometimes they approved a new dosage without actual testing and it turned out in at least one case the delivery mechanics didn't work properly.

Deregulation is like reform. Enough people think it's automatically good, that it's completely meaningless, and because it's meaningless the worst people pick it up as a slogan and run with it.

As someone that could really benefit from new drug approvals, I don't see deregulation as my savior because if it's executed by the worst people, then it will just lead to more snake oil and less ability to differentiate.

I’m not an expert, but I’ve worked with the FDA. In my experience they’re pretty reasonable and motivated by mission. I suspect it’s simply really hard and risky to come up with new therapeutics and make sure they work in a reasonable amount of time. Diminishing returns.

I don’t know anything about the generic drug marketplace. I’d guess the issues are more complicated than what you describe. The FDA’s mandate is safety, not anticompetitive practices.

One surprising takeaway from working with our regulatory consultants is that apparently many actors try to game the crap out of the FDA’s processes. The FDA is really the only wall between shenanigans and consumers.

Generics still have a huge effect in driving down prices and patent cliffs for small molecules are as devastating as they have always been for big pharma. It makes sense that it's not easy to create a new generics company because it's such a perfect expression of the free market - fierce competition leads to the profits being competed away. It couldn't be cheaper to start a generics company (and there's plenty popping up overseas) - but there just isn't that much money in it unless you already have the infrastructure or have a competitive advantage in cost

>So the big name brand drug companies just buys them all up. And because of that they no longer face competition from generics. They own both the name brands and the generics.

Didn't something like this happen with Martin Shkreli? From what I've read, the drug that they upped the price on had its patent expire decades ago. It's just that nobody else was producing the drug, presumably because it wouldn't make enough money. This resulted in essentially one company being the sole source of the drug, not because of patents, but because of cost.