To what extent is the FDA in the pocket of industry?

[RetroVertigo]

@DrCube

The inspections, clinical studies and drug disapprovals are not proof that the FDA isn’t in the pocket of industry, in fact the opposite. All that bureaucracy, the expensive regulations and the inspections, keep new competitors at bay.

Sure, Bayer still competes with Pfizer, but when was the last time a plucky entrepreneur with a dream started a new, innovative pharmaceutical company? Bayer competes with Pfizer at the same old pharmaceutical game they’ve been playing for a century. But they’re both on the same team when it comes to preventing a newcomer from shaking up the industry.

The bio-pharmaceutical industry is booming with smallish start-ups.Now very often these molecules are bought-up by Big-Pharma, but that is not the situation as what you described.

[bleach]

@DrCube

My point is not to argue against those situations, but to point out that companies often, counter intuitively, like the barriers to entry that regulation creates. That means you can’t just say “See how the FDA cracked down on drug X? That’s proof that they’re not in Pfizer’s pocket”. Because mandating those extensive clinical trials and occasionally rejecting drugs is how the FDA keeps new, potentially more threatening, competitors from disrupting the pharmaceuticals market. Because Bayer is a known threat, against which Pfizer can plan. It’s the unknown future competitors that are really scary. The FDA and other regulatory agencies act as the “keep out the unknown unknowns” tool of entrenched corporations.

DrCube, Farin has explained the situation very well, and I think most people in the pharma industry would agree with his counter-arguments.

There are discoveries all the time of promising drugs for different things. Ones that get people excited tend to find funding; there are tons of ways to raise money for trials. I work in cancer research. When people give money to “Cancer Research”, people like me write grants to get a piece of that action for my clinical trials. If those clinical trials go well, then I can partner with Big Pharma or shop around my results to venture capitalists or otherwise raise money and become a little pharmaceutical company.

I don’t think your premise is correct. The regulatory barriers are there as a “price of admission” if you want to sell a drug in the USA. If your company is in that business, then you submit an application to FDA or EMA or PMDA, and you follow their rules.

Bayer and Pfizer and Lilly and Roche compete on some diseases but there are tons of boutique diseases where they don’t have the infrastructure. A little nimble pharma company can specialize, as RetroVertigo said.

Big Pharma buys out little pharma all the time. They would rather the little guys take the risk in early stage drug development. Lots of drugs fail in early phase trials. Big Pharma can wait, and then swoop down later, buy out the IP, and reap profits on other peoples’ money when they do later-stage drug development. To Farin’s point, in the meantime, little pharma has to pay the money to comply with FDA regs, even if their drug is found not to work.

One of biggest differences between big pharma and small pharma is that Big Pharma has processes and procedures in place so that their interactions with FDA are more efficient. They know how to satisfy FDA regs and conditions before FDA asks. Compare that to a rag-tag group of first-time drug developers; they will stumble around trying to conform to FDA’s standards and waste time because of not understanding all of the FDA requirements.

That’s a big competitive advantage but it’s not the same as FDA being in the pocket of industry.

[asterion]

Pharmaceuticals are really complicated. A small company (or even an academic) may have the facility to make small amounts of material. Definitely enough for initial screening, maybe even enough for very early preclinical work. But they’re probably not going to be able to make the amounts needed for animal testing. And they definitely won’t have the equipment and abilities to make the amounts needed for actual clinical testing under GMP. So they basically need to work with a CRO, which does have the experience and equipment to do the work to make hundreds of grams or kilos of stuff, at least to the point where a larger company is willing to partner or buy the IP. And in the meantime they’ve probably had to spend a lot of time getting funding from VCs because CROs are not cheap. The problem with pharmaceutical development isn’t having a new lead compound. It’s getting it into commercial release and that is not caused by some sort of Big Pharma/FDA conspiracy.

[Budget_Player_Cadet]

@DrCube

My point is not to argue against those situations, but to point out that companies often, counter intuitively, like the barriers to entry that regulation creates. That means you can’t just say “See how the FDA cracked down on drug X? That’s proof that they’re not in Pfizer’s pocket”. Because mandating those extensive clinical trials and occasionally rejecting drugs is how the FDA keeps new, potentially more threatening, competitors from disrupting the pharmaceuticals market. Because Bayer is a known threat, against which Pfizer can plan. It’s the unknown future competitors that are really scary. The FDA and other regulatory agencies act as the “keep out the unknown unknowns” tool of entrenched corporations.

So what? What’s the alternative? Yeah, an advanced regulatory work that ensure product quality at the cost of bureaucracy gives the established big names a clear advantage. So what? The fact is, we need that quality control. It’s the barrier between “knowing how the drug works, what’s in it, and what side-effects there are” and “not”.

[Antigen]

@RetroVertigo

I work in Pharma, and this is the exact opposite of my experience. We know when the general timeframe (month) that our annual inspection, but they never say when they are on the way. They also can pop in whenever they want for a surprise inspection (this is also true of the Europian and Asian agencies).

We also couldn’t just stop with a process while they were here. If it was a certain step they wanted to see they would keep coming back until they got to see it.

That’s my experience as well. Also, we are required as part of our “good laboratory practice” to have a master schedule for our production, and if the FDA shows up on a big production day, them’s the breaks. We can’t just not do the scheduled work because they’ve showed up.

I work in manufacturing blood grouping reagents - not quite pharma-level scrutiny, but we get the pharma inspectors anyway so they’re pretty brutal. They can be nitpicky as hell, especially in places where the regulations are open to interpretation.

[Jackmannii]

@DrCube

Sure, Bayer still competes with Pfizer, but when was the last time a plucky entrepreneur with a dream started a new, innovative pharmaceutical company?

You mean like this? Or this? Or this? Or this?

The FDA had better start cracking down on these companies. Its Evil Plan isn’t working.