According to various CTers, the FDA is nothing but a shill organization. While I don’t believe that, I am dubious that it is immune to lobbying efforts. For example, I hear tell that the food pyramid is skewed to include more servings of whole grains that is perhaps necessary at the behest of Big Ag. The Lancet has recently published a (I think) metastudy reviewing exposure to substances such as BPA and is recommending that legislation be passed to require companies to test new substances against developing brain tissue and prove that it’s safe before being allowed to market it (I thought the FDA already did that). Link. One of the substances the study looked at is fluoride (I gather they mean overexposure, but the article isn’t clear). I would hate to put a feather in the cap of scaremongers like Alex Jones, but if the facts say that water fluoridation is bad for developing brains, it doesn’t matter what I think.
If I had to guess this post is probably the result of various food additives you keep hearing about. Well, the FDA is a creature of statute, and the F in FDA is probably the weakest element of its regulatory mandate. Things regulated as foods are subject to much weaker scrutiny than things regulated as drugs. Not because the FDA is in the pocket of industry, but because it can only operate under the statutes governing it and those statutes make its food oversight authority much weaker than its drug oversight authority.
I think when it comes to pharmaceuticals the FDA has shown it isn’t in the pocket of industry. They require years of animal and human trials, and drugs that major pharmaceutical companies invested billions of dollars in developing have regularly been rejected for approval at the final stages. That’s not indicative of an agency that is in the pocket of industry.
But it’s also worth noting any pharmaceutical is going to be a complicated substance that can be difficult to fully predict in terms of its long term side effects and potential short term side effects over the entire population of the country. So even rigorous testing can result in a drug that seems fine, but we later learn there are problems with. I don’t view that as a failure of the FDA or even pharm companies, but just the reality of the science. Lots of drugs save or prolong lives, but we’ve also had quite a few get through rigorous testing and end up ultimately having unforeseen side effects. Sometimes we’ve caught pharm companies hiding those side effects during human trials, but that’s (and I don’t want to sound naive) generally the bad behavior exception and not the norm.
If you want the FDA to scrutinize food more you’d need to talk to congress, not the FDA.
The problem with food is that it is designed with ten to twenty ingredients per dish, even if it’s “all-natural” and you aren’t adding Vitamins and such, it’s still easy to move a dish into the tens of ingredients category.
To vet each of those ingredients 100% of the time is hard as sin in the best of circumstances and impossible in any real world.
The FDA, for the food part, has a fairly comprehensive set of things you are required to do as a meat or produce provider, which is supposed to catch as much as possible in terms of diseases and all that other fun stuff. The problem is that it’s real-world impossible to provide both mass distribution of foods and 100% safety. In general, the FDA has shown itself good at reviewing potential methods and technologies and weighing the costs and benefits of implementation.
The “controversy” that tends to get stirred up tends to be driven by businesses distorting the reality in the media. For instance, two or three (?) years ago there was an e. coli contamination in the lettuce that went to a lot of pre-packagers (fast food, salad-in-a-bag, etc). Not only was the lettuce mandated to be recalled and destroyed, but people came out of the wood work that went “If only we’d implement the technology that my company made we’d not be in this situation!” to hopefully drum up popular support and drive their sales through political pressure.
While I can’t say I agree with everything I’ve seen the FDA do over my life time, I can’t say that I’ve seen evidence that would make me consider them particularly beholden to industry groups as a whole.
My experience with the FDA comes from the animal feed industry. I ran the medicated feed program for at least 15 years at a feed plant. The tracking, inventory control, sampling, testing, etc of the drugs we put into some of the feed produced for treatments of disease and prophylactic treatments.
You might be under the impression that the FDA and USDA act as industry watchdogs to keep the manufacturers in line. You would be quite wrong, in my experience. They act as facilitators and industry partners. I worked with the inspectors to develop a program that met all of their concerns and when a new concern came up it was incorporated into the program.
This made life easy for both the agencies and the manufacturer. In all of these years I never once had a surprise inspection, they always called ahead to make sure I would be available on the day they planned to arrive. “Are you going to be there next Tuesday? It’s time for your annual inspection.”
And so of course we were never actually producing medicated feed on those days, but they could look at the books and take a few samples and be on their way. I did not experience any sort of watchdog type investigations that some people might consider as a FDA function.
Lemtrada - MS drug expected to generate $3.5bn in sales for Sanofi, rejected by the FDA due to having poorly designed trials.
Cangrelor - Anti-clotting drug for use in surgeries, rejected by FDA>
Qnexa - Initially rejected, resulting in a massive share price decrease for the smallish pharm company that was making it, later approved under the name Qysmia.
Merck has faced investor criticism due to its anasthesia-reversal drug (sugammadex) and its insomnia drug (suvorexant) were both rejected in 2013. Merck is one of the major pharm companies and has been fighting to get sugammadex approved in the U.S. for years, it’s already being sold in Europe and the rest of the world but the the cost of it not being approved in U.S. markets has been estimated at as much as $700m/yr in revenue.
I really only know about these through the financial news I read, anytime a late stage drug is rejected the pharm company usually makes the headlines in the WSJ/FT/Bloomber/et al. because investors react like mad men to that sort of thing. It’s one of the strange things about the big pharmaceutical companies, they basically have to have a healthy pipeline because unlike say, Gillette razor blades, Tide detergent, Coca-Cola etc you can’t truly establish a long term brand as a major pharmaceutical company. Once patent protection is gone generics flood the market and while some residual income from the brand name product continues on most consumers and health insurers won’t pay the premium price for the brand name drug when a generic is available. So no matter how big and powerful the pharm company is (so this includes the likes of Pfizer, Merck, Novartis, GSK etc), they need to have a continual pipeline of successful new drugs. A few rejections in a year causes serious fears from investors and it makes the news when it happens.
Tivozanibwas rejected after Phase III trials (Phase III is the last round of testing before market; Phase IV is after market monitoring). The company had to lay off a ton of people and “restructure” so they could do a new Phase III trial.
Lorqess had beautiful Phase III trials with side effects nearly indistinguishable from placebo, and everyone was certain it would be approved back in 2010. The FDA shocked the hell out of folks by rejecting it for what they thought was something that should have been pursued back in Phase II trials (it caused cancer in some rats, but not in humans). That sent Lorquess back through two more years of testing before it was approved with staggering restrictions in 2012 as Belviq.
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.
*Types of FDA Inspection
FDA inspection can broadly be divided in two distinct categories – Surveillance and Compliance inspections. While the former category can be described as a routine inspection category, the latter takes place with a specific objective…
Pre-announced/ Routine Inspections
In case of pre-announced FDA inspection, the investigator contacts the firm to be inspected. From local District Office, the FDA investigator contacts responsible person at site.
For domestic manufacturers, generally, FDA notifies the firms five days before the inspection whereas for foreign manufacturers, the notification is sent two to three months in advance.
Unannounced/ Directed Inspections
FDA often conducts unannounced or directed inspections. Therefore, being prepared for FDA investigator’s surprise audit is the only solution to escape from FDA’s warning letters. *
While the FDA is certainly not perfect, the USDA is a better candidate for this accusation. The USDA is responsible not only for safety and regulatory inspections, they also are responsible for nutritional guidelines. This can get little hypocritcal when they are also required tosupport certain food producers:
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.
This sort of deal extends to a lot of industries. Why do I need a doctor’s permission to buy an asthma inhaler? Because the AMA has mandated (and the government enforces) that I pay an expensive doctor a lot of money to tell me what I already know. I can’t make my own decisions about my health because that would offer an inexpensive alternative to an otherwise lucrative monopoly.
Why can’t a smart paralegal hit the books and take the bar exam? Because law schools (and the lawyers who staff them) have decided it’s in their best economic interest to mandate a law degree before being allowed to practice, even if you could pass the bar (and provide excellent legal counsel) otherwise.
Why can’t I set up a still and sell Cubey’s Homemade Whiskey to local bars and restaurants? Because the established distilleries have decided it’s in their best interest to force newcomers to pay for expensive permits and submit to onerous inspections. The big companies can afford it, but it sure creates a barrier for a would-be whiskey startup.
Regulatory capture isn’t about going easy on the biggest businesses. It’s about coming down hard on anybody who might shake up the status quo.
Actually, it’s very, very, very common for researchers to discover Drug A - Potential Cancer Cure and then get bankrolled by a drug company for years while it undergoes testing. But that’s in the public interest.
In times past when freedom of this sort was allowed, every tom, dick, and harry released things like Heroin cough syrup for your children. Coca-Cola, for all that’s holy, was a* medical elixir* with cocaine in it.
Having this regulatory capture makes us safer and it’s in areas we really don’t want people offering homemade remedies or solutions.
Because, without that capture, you will have people self-medicating on bronchodialators that are low-grade steroids. This can lead to your lungs becoming dependent on the steroids to function properly and trying to kill you every time you are out of inhaler gas. If you think this is too much hand-wringing over what should be a personal failure, look at antibiotics. After they were shown on television being prescribed by doctors, people would go to the doctor and get them when they got the sniffles. After 30 years, a doctor just knee-jerk prescribes them, and it’s made their effectiveness wane (And created bacterial super strains.)
As for the “onerous” requirement of seeing a doctor, my wife had to go once to get branded an asthmatic in her teens. Every doctor she’s had since has checked her medical records and given her a prescription for an inhaler without an office visit. The only other time she’s been to the doctor about it was the two times she went to the ER because she was dumb and didn’t refill when she was almost empty.
Because of the relationship between lawyer and client and the unique legal status you can wring out of it. If you can, for instance, prove your lawyer was incompetent - you can probably win yourself a new trial. Now imagine if you can prove your good test taker guy who passed the bar exam is a book learner and a bad lawyer. You inevitably jam up the legal system for no good reason because people went to Hank’s legal advice ($8 / hour!).
Because, back in the day, you would buy whiskey that was spiked with wood-grain alcohol (methanol) to make it more lucrative, since that’s cheap as dirt. So, sure, I can trust ol’ Cubey’s whiskey. But that Farin guy? He’s shifty as hell and will sell you and all your drinking buddies up the river for six Mexican pesos.
In a lot of places, you can run your own microbrew for personal consumption. You have to get certified if you want to sell that commercially so that if you manage to make Methanol-Plus you only kill five or six people and not five or six hundred.
No, in the cases that regulatory capture is used properly, it’s used to protect the public interest. You can certainly go overboard, but in most cases it’s because humans are a giant sack of assholes and we, as a society, have had to try to counter that tendency.
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.
Honestly, pharm companies aren’t afraid of little guys. Pretty much every little guy they encounter, they can eat. They can either purchase their stock and take them over hostile-style or write a check larger than the imagination of the current owner.
Even if they were directly competing with a little company for some reason, they wouldn’t care. Every drug is a niche and there’s no current portion of the drug market that would be eaten away. You aren’t going to unseat something like Lamictal just because you bring to market Prozac 2. The drugs that are well known there only work for certain people. A doctor will transition you from lamictal to prozac to zyprexa to that combo prozac/zyprexa med (Zymbalt? Something like that) until your symptoms are manageable.
All of the meds they come out with are like that. Everything from blood pressure to cancer treating drugs. Doctors experiment and find your individual best product. Unless you come out with a drug that cure blood pressure or leukemia or something, you aren’t going to eat anyone’s lunch.
My opinion is that would be true even without the barriers to entry. Biotech takes a lot more than opiates in sugar water, after all.
I have proof that the FDA is in cahoots with the food industry. It’s in my refrigerator. It’s a plastic tub of Kroger brand pimento cheese, which I lurve. I’m on a salt-restricted diet, so I checked the label and one serving of pimento cheese is 320 mg of sodium, a lot, but as the main salt source in a lunch meal that consists mostly of a pimento cheese sandwich, not horrifying.
Until I read the serving size: 1 tablespoon.
That is purest bullshit, one tablespoon of pimento cheese is not anywhere close to enough to make up a decent sandwich. Three or four, maybe enough for a half sandwich where you fold a single slice of bread over. Still pretty thin. The ONLY reason I can imagine for having such a paltry amount allowed as a “Serving” is so that the amount of carbs, fats, sodium, etc., look reasonable … if you don’t notice the serving amount. If I had seen that one serving of pimento cheese was, say, 1800 mg of sodium … pretty much my entire day’s intake of sodium … I’d have dropped that tub of pimento cheese like it was radioactive.
So, yeah … FDA is definitely in the food industry’s pocket.
Totally wrong. The severe restrictions and penalties on illegal distillation didn’t grow out of some sort of cartel-like desire on the part of the big distillers, but rather from the US Federal government in the interest of collecting the taxes that they’re due, and a series of state laws that mostly date from the Prohibition era and before that seriously restrict distilling in those states.
There’s a growing microdistillery movement that pretty much disproves your theory; once the government figured out how to properly tax it, and the state governments loosened their sphincters a bit, it took off like gangbusters. Hardly the expected or planned for result if Heaven Hill, Diageo, Seagrams and the like were bent on quashing it through legal means.