3 ms·

The FDA has a solid origin story: make sure drugs sold are safe. But the 1960s expansion into regulating efficacy has not been positive, and the organization to

by jefftk 4y ago

The FDA has a solid origin story: make sure drugs sold are safe. But the 1960s expansion into regulating efficacy has not been positive, and the organization today is not even clearly positive on balance. Today if the FDA approves a drug as safe, and effective for any single specific use, doctors are allowed to prescribe it "off label" for any other use. This generally works well, and contributes to pharmaceutical innovation. We should expand this to where doctors can prescribe anything the FDA has classified as safe. Restricting advertising and other carrots to drugs that have convinced that FDA of their efficacy (as we do today for off label uses) is probably still good, though.

derbOac 4y ago
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.
adrianN 4y ago
Why is it better to decentralize the burden of checking the science behind efficacy claims?
- jefftk 4y ago
  It's primarily not centralizing checking the science I object to, but the setting a single threshold for all of society. People vary a lot in what level of efficacy evidence would make taking a given medication worth it for them, and in cases where safety evaluation has already gotten us to where the downside looks like "it doesn't do much, money wasted" I think making distribution of the substance illegal is much too restrictive.
samatman 4y ago
I don't think that advertising drugs to consumers should be legal. I'd go further, and restrict advertising to doctors to a specific format, something like the Nutrition Facts label we have for food. They'd be allowed the brand/trademark, but everything else is specified to be in effect a data sheet. The only thing allowing advertising to consumers will do is result in a lot of them insisting on, or agreeing to, drugs they don't actually need.

by jefftk 4y ago

derbOac 4y ago

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.

adrianN 4y ago

Why is it better to decentralize the burden of checking the science behind efficacy claims?

jefftk 4y ago
It's primarily not centralizing checking the science I object to, but the setting a single threshold for all of society. People vary a lot in what level of efficacy evidence would make taking a given medication worth it for them, and in cases where safety evaluation has already gotten us to where the downside looks like "it doesn't do much, money wasted" I think making distribution of the substance illegal is much too restrictive.

samatman 4y ago

I don't think that advertising drugs to consumers should be legal. I'd go further, and restrict advertising to doctors to a specific format, something like the Nutrition Facts label we have for food. They'd be allowed the brand/trademark, but everything else is specified to be in effect a data sheet. The only thing allowing advertising to consumers will do is result in a lot of them insisting on, or agreeing to, drugs they don't actually need.