The general problem is there's not enough basic funding to fund quality safety trials. Which are still run, but by the manufacturers themselves.
What probably should happen is more pushback from agencies with downstream remits like the DEA once statistically durable negative effects are observed on the ground.
In my personal opinion, medicines in the US are far too regulated. I agree with what you're saying about efficacy versus safety, but I'd even go further in my stance that safety is really overstated. There's a huge difference between something like the safety profile of elixir sulfanilamide and most of the drugs on the market today. Many of them could be distributed without a prescription over the counter, or distributed behind counter under the regulation of pharmacists, or distributed with a prescription by a wider range of providers. It's absurd to me that something like alcohol is something you can buy in the grocery, but something like acyclovir requires a prescription.
I know my personal opinions about this are unusual, statistically speaking, but I think the pendulum has swung far too far in the other direction since the 1930s. It's frustrating to me that debates in the US are often framed in terms of two extremes, one resembling what we have, which is broken, and another where there's no safety oversight at all, as if those are the only options.
I personally feel like the FDA should concern itself with regulating the characterization of basic safety profiles of substances, and with product purity and truth in labeling. Outside of that, it seems like you start getting into rent-seeking.
I agree with this. FDA approval shouldn’t be the issue since it’s safe when administered correctly and has medical purposes. Controlling distribution should be the issue. There almost needs to by a super controlled substance drug class
The problem is the approval of drugs that don’t actually work, and so are actually harmful.
the approval then means that companies can target people who are desperate with extremely expensive snake oil. The victims of this have no recourse if/when the drug has caused problems.
The way to solve it is to have different branches with checks and balances. The FDA is one such branch that should, in theory, not care about anything other than consumer safety, the legislative branch limits it's powers so it doesn't go too far and stop innovation, and the researchers try and beat the best of FDA's powers with evidence that their drug is safe.
If something is broken there, it's because of leaky incentives (ie, people not really caring about the consumer on the FDA because of a revolving door with industry) or because it's imbalanced (the FDA has too much power and it can shut down drugs with legitimate evidence of safety, for example, or not enough power, or drug companies don't have enough money anymore to convince the FDA, etc)
The FDA isn't meant to stop snake oil. See all of the perfectly legal alternative medicine out there. And this is far from snake oil. They are meant to protect against dangerous drugs. They even do that badly. I remember seeing a statistic that more people die from drugs being delayed from going to market than are saved by preventing bad ones. The high standards also make new medicine and innovation ridiculously expensive, though it's debatable whether it's worth the cost.
I think it's more of the limitation of liability at this point. Whether or not any central authority endorsed it is moot when 100 million doses have been given.
The big problem for me is in making light of the process that, perfect or imperfect, is a extremely important in a for-profit pharma paradigm.
The FDA approval process ensures both that drugs perform an intended function, and that drugs don't harm people. Part of the expense of this process is making sure that both of these aspects are performed to sufficient standards.
It sounds like your suggestion would lower the bar for both these aspects, and only catch issues after the fact - something which could have fatal consequences.
I'm curious how you would see this playing out in a positive light, particularly given the money involved and the incentives to game the system.
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.
The problem there is that FDA has statutory authority to regulate some things and not others. (The notorious exemption is "natural supplements.") But the FDA takes a remarkably thorough approach to what it does regulate. Let me give two examples.
Example one: I have been in two FDA-regulated medical trials. One was a placebo-controlled trial of taking fexofenadine daily for indoor allergies. I had no idea if my numbered supply of tablets was placebo tablets or genuine tablets. I had a schedule for taking them, and had to keep a detailed log of symptoms. The second clinical trial I did was a trial of consumer-facing store displays for a proposed over-the-counter medicine for controlling cholesterol. At the test center, there was a mock store display that looked just like the shelves of a pharmacy, and I read the mock labeling and then was asked several questions about my understanding of the purpose and use of the drug. I was even given a brief IQ test as part of the trial, to see how my understanding of the store display would compare with that of someone with a different level of IQ. The FDA is thorough, and it relentlessly uses carefully gathered data and statistics analyzing those data to make regulatory decisions.
Example two: My son the hacker had a summer job while still a university student writing code to control the display of a test device to be used by medical doctors in a hospital or clinic setting. He had to think through all the user interactions medical doctors would have with the device, and how to code the device so that it would have high usability for doctors and high reliability. As he neared the end of his summer job, medical doctors came to the medical device company where he worked to do carefully monitored usability testing of the product. My son told me at the end of the summer that the product he worked on would have to be tested with regard to all aspects of hardware and software for several more years, including a complete line-by-line code review of all his code by FDA specialists in software. He heard from his bosses that time to market for that product would be as much as five years after the summer when he worked on it (in other words, still in the future today). The FDA is very thorough in its regulation of medical devices. I also know this from an electrical engineer who is a childhood friend of mine, who has long worked in another medical device company in our town, which has major medical device companies headquartered here. Safety is job one at the FDA. Effectiveness is job two. Both have to be proven before a new drug or medical device goes to market.
Simply put, the people at 23andMe have been doing what a mathematician calls "hand-waving," concluding things that they haven't proven. That helps develop a kind of zeal for the task for the long haul, but it doesn't ensure that the task gets done right.
That's not how the drug industry works. The companies fund and conduct their own efficacy and safety trials, the government just rubber stamps them. The FDA doesn't perform an actual science. They don't even require an impartial group to replicate the science.
The FDA doesn't do really much of anything to collect safety data. There's seemingly no reason for the agency to exist.
Is anyone even reading my comment or any of the comments above me? I'm not arguing against the FDA's safety requirements. The argument is for decoupling safety from efficacy requirements to make a treatment available to acquire. Right now availability is coupled with mandatory coverage by Medicare & insurance, which means treatments with borderline/controversial efficacy results like this Alzheimer one is either totally banned or mandatory for prescription & coverage. You wouldn't be able to sell heroin.
We don't follow that pattern with 3 of your 4 examples. The FDA regulates and approves anesthetics, antibiotics, and birth control drugs. We required new drug makers to prove both safety and efficacy of their medication before they are approved for use on the general population.
I think I think we should do the same thing for industrial chemicals/additives or anything that gets released into the environment from an industrial/commercial process.
You don't get to poison the town then say "oops how could we have known better".
This is more or less how I've felt. There are so many high-risk behaviors which are perfectly legal, and when our right to take risks in those ways is challenged, there is generally backlash; but in the case of drugs we are legally prohibited from taking risks.
I think the FDA's prohibitive authority does more to protect the interests of established pharmaceutical manufacturers, than the interests of consumers.
The problems with drugs are entirely government created. Through the granting of monopolies on drug formulations through patents and then through the licensing by the FDA that prevents other manufacturers to produce already approved drugs if they're not exactly the same.
As with COVID we are seeing that the FDA fails to serve the public and is overly cautious. If we want an FDA make it voluntary, separate testing danger from effectiveness and at the end of the day let each individual do whatever they want to their own body.
When a private actor is exploiting a flaw in the regulatory system, it might be easier to fix that flow or strengthen other parts of the regulatory system (eg perhaps there are remedies in antitrust law), rather than impinging on a property interest because we don't like the outcome.
Here the problem is that other manufacturers can't take up making these drugs at a sensible price because they have to get FDA approval for their copies, and doing that requires test comparisons with the original drug which you propose to copy to ensure that they behave identically. So either we need to change that requirement to a different testing approach (eg proving your copy is good through chemical assay rather than in a clinical trial) or by making licensing contingent on cooperation with regulatory priorities (so if you want to sell your off-patent drug, you have to make samples available to would-be competitors or provide the FDA with samples on request and at cost).
Doesn’t need to be legal enforcement. The FDA could simply start taking its time when issuing new drug approvals, study registration, etc, for bad actors. A substantial quantity of a pharmacy company’s budget and product development cycle is devoted to dealing with the FDA as it is, making it any worse would be a big deal.
I think some regulation is needed though. I can't look at a generic white pill and tell whether it's oxycodone or acetaminophen. Also, I don't want to take your acetaminophen if it hasn't been proven that whatever is in it won't cause other more serious issues or that I've at least been adequately informed of those side-effects on the front-end.
R&D is also in-part expensive because of the success rate of drug trials and the expertise necessary to conduct the experiments. I'm mostly a free-market proponent, but when a corporations own interests collide with the larger market's interests by killing or otherwise removing a large portion of the productive population from the workforce, I believe there should be regulation.
Consequently, if they make over-prescribing legal, then it is.
Similar problem with the EPA chemical safety division: https://news.ycombinator.com/item?id=28092336
The general problem is there's not enough basic funding to fund quality safety trials. Which are still run, but by the manufacturers themselves.
What probably should happen is more pushback from agencies with downstream remits like the DEA once statistically durable negative effects are observed on the ground.
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