FDA

Most Drug Expiration Dates Are Bogus, and the FDA Knows It

At the government's behest, hospitals trash nearly a billion dollars worth of perfectly safe and effective medicines every year.

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Photo credit: Mpelletier1/wikimedia commons

Hospitals in the U.S. throw away $800 million worth of unused medicine every year, and pharmacies and consumers trash uncounted millions more, all because they didn't use or sell those medicines prior to the date printed on the bottle.

But according to a new report from ProPublica, most of those drugs are safe and effective for years after the expiration date. And the Food and Drug Administration (FDA) knows it.

"It turns out that the FDA, the agency that helps set the dates, has long known the shelf life of some drugs can be extended, sometimes by years," writes ProPublica's Marshall Allen. "In fact, the federal government has saved a fortune by doing this."

Allen explains:

For decades, the federal government has stockpiled massive stashes of medication, antidotes and vaccines in secure locations throughout the country. The drugs are worth tens of billions of dollars and would provide a first line of defense in case of a large-scale emergency.

Each year, drugs from the stockpiles are selected based on their value and pending expiration and analyzed in batches to determine whether their end dates could be safely extended. For several decades, the program has found that the actual shelf life of many drugs is well beyond the original expiration dates.

A 2006 study of 122 drugs tested by the program showed that two-thirds of the expired medications were stable every time a lot was tested. Each of them had their expiration dates extended, on average, by more than four years, according to research published in the Journal of Pharmaceutical Sciences.

An official with the Department of Defense, which maintains about $13.6 billion worth of drugs in its stockpile, says that in 2016 it cost $3.1 million to run the extension program, but it saved the department from replacing $2.1 billion in expired drugs. To put the magnitude of that return on investment into everyday terms: It's like spending a dollar to save $677.

I suggest reading ProPublica's entire report, which provides one stunning example after another of bureaucratic cautiousness fueling rational but egregiously wasteful behavior. Hospitals don't dispense perfectly safe but expired drugs because that may expose them to regulatory penalties or lawsuits. Pharmaceutical companies don't push back against the FDA "because regulations make it expensive and time-consuming for manufacturers to extend expiration date." And the FDA won't do anything, because…well, ProPublica doesn't really provide a good explanation. The simplest explanation is that regulatory structures are like weeds: They don't uproot themselves.

There is no top-down fix in sight. The American Medical Association has apparently been drawing attention to this issue for over a decade now, but the FDA has made exceptions only in the case of medicine shortages. But that doesn't mean consumers have to comply.

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  1. Even milk can last 2-3 days past it’s printed “use by” date. Sheesh

    1. I just had some half-n-half in my coffee that expired on August 3. I am fine.

      Excuse me, I’ll be right back.

    2. Yes, and there are two types of date on food: “sell by” and “use by.” If you buy food on the “sell by” date it still has about a week or so to go. Usually these things are discounted. Half price meat being sold on the “sell by” date is fine (or just as fine as any other meat that store sells). People usually are afraid to buy anything being sold on or near the “sell by” date even though it’s not the same as “use by”.

      1. Even if past a “use by” date, you can usually tell if meat or milk should not be consumed.

      2. About the only item you don’t want to push the date on is milk. Most other foods are fine. Canned goods can go a decade past the “sell by” date. I had to use an antibiotic a few months back to counter a foot infection. Was able to get by just fine on 34-year-old Minocin. Worked just fine. But if you’re going to store drugs for more than a decade, you want to keep the temperature reasonable and use a glass bottle. Plastic bottle, or heat, and things get “iffy”.

      3. I think Stossel did a report on this, and, IIRC, the two terms are actually interchangeable and the dates are relatively arbitrary. FWIW, I have a loud fridge I sometimes shut off when I record audio, and I’ve forgotten my non-dairy coffee creamer in there for two days before without refridgeration and I’m still alive. Unless it smells funny, you’re probably fine. Bacteria usually causes smells, so without an odor, you’re usually good to go.

  2. But that doesn’t mean consumers have to comply.

    The pain meds I use to deal with kidney stone pain are five years old.

    1. OPIOID CRISIS!

      1. Yes, they are so irresistibly addictive that Sparky has saved them for 5 years.

  3. And the FDA won’t do anything, because…well, ProPublica doesn’t really provide a good explanation.

    Because FYTW.

    1. No, it’s because they’d need a rulemaking, & there’s no way to make a rule that works the way you’d want it to. Most drugs are still potent & safe well beyond their expir’n dates, but the burden of proof is on the mfr. Congress says they have to show drugs are safe & effective in the opinion of qualified experts, FDA just carries out what Congress set forth. People here keep blaming FDA for Congress’s fault. & the tort bar’s, when it comes to hospitals throwing stuff out.

      The tort bar’s going to require expir’n dates no matter what. That’s then art of the product’s labeling. Unless Congress amends the FFDCA to say mfrs. are allowed to lie on their labels, & exempts them from liability, thereby abrogating our 5th amendment rights….

      1. The main reason medicine is so expensive is government interference. Get rid of “prescriptions”, make all drugs legal, provide information and let the smart people treat themselves and let the stupid ones poison themselves.

        We’re long overdue for a bit more Darwinism anyway.

        1. Our doctor told my wife that diabetes does not effect the kidneys. I “googled” this and got pages of sites that said that it did. As a matter of fact, diabetes is the most common cause of kidney failure.

          I suspect that “Doctor Google” is far more knowledgeable than human doctors are.

  4. But that doesn’t mean consumers have to comply.

    Ha ha! Really?

    1. So far.

  5. We store many compounds in the lab for many years, without degradation. Yes, some things are not stable, or require special storage, but the large majority are stable for decades. And, the manufacturers know exactly how stable they are, but have negative financial interest in pursuing an empirical dating methodology.

    1. Profit is the primary reason the drug companies exist. If they can’t profit off of something, they have absolutely no interest in it. If they can’t patent or copyright something, they ignore any facts that might be presented as to what it might cure. The “God” that they worship has the symbol “$” and his temples are banks.

  6. TO prevent the government from stopping me I store all of my medications inside of me at all times.

    1. The first step is to admit you have a problem.

      Storage problem that is!

  7. RE: Most Drug Expiration Dates Are Bogus, and the FDA Knows It
    At the government’s behest, hospitals trash nearly a billion dollars worth of perfectly safe and effective medicines every year.

    That’s not the point.
    The point is hospitals can now charge their clients more money for more medicine, have the FDA more power over us little people and waste perfectly good medicine.
    Isn’t this why the FDA was originally founded?

    1. Wall St. Jrnl said the same thing as is said here, 15 or 20 years ago.

      FUCK the FDA, those utterly evil bastards!!!

      1. One thing that the Wall St. Jrnl article mentioned that is not mentioned here is, American drug companies would be very happy to donate “expired” or “near-expired” meds to third-world nations, where people are dying, for lack of these meds. Snooty-bastard big-wig politicians in those third-world nations turn their noses up at such meds (even though they could save lives) by objecting, basically, that “Oh you high-and-mighty, superior American dogs offer us your sub-grade, inferior shit. We’re too good for that. Take your expired meds and shove them!”

        Good press I suppose for lefty dipshit 3d-world big-wig politicians, among the Koch-brother-hating crowd, but meanwhile, poor people there die for lack of these meds!

        1. So why not make them available to Americans? I mean, just tell them, “they’re past the government-recommended expiration date and come with no warranty – but here – take them if you want.”

          Oh, that’s right. The “government” knows what’s best for us.

          1. To expand this further, create two categories of drugs. One is FDA approved, the other isn’t. This would get experimental drugs into the hands of people who have a disease that will kill them before the FDA (as corrupt as the rest of the government) gets around to “approving” them. Note too that quite a few “FDA approved” drugs get withdrawn after being on the market for a year or two. So the FDA isn’t perfect either.

    2. Along with the profit the drug companies make by making more of it. It is in their interest that the drugs get “tossed” because if they aren’t “tossed”, the drug company doesn’t make a profit.

      Libertarians often talk about “free market medicine”. Note that a free market can only exist when organizations that can restrict supply are outlawed. When it becomes a felony to create any organization that seeks to gain through restriction of supply. This is the one and only way that a free market can continue to be a free market.

  8. Chemicals: How do they work?

  9. Hospitals in the U.S. throw away $800 million worth of unused medicine every year…

    And this is why rats are unkillable. They leave our garbage dumps extremely well medicated.

    1. How do you kill a rodent that is anxious because of nature but not anxious because of SSRIs, strong because of steroids, resistant to every bacteria known because of anti-biotics, immune to pain from opioids, and delusional from various psychotropic drugs?

  10. “bureaucratic cautiousness” is a heck of a euphemism. I prefer the more accurate ‘crony capitalism’.

    Really, politicians should put themselves on eBay. It would be so much more honest.

  11. Canned meats can also be safely consumed several years after the marked expiration date. Along with much canned fruit and veg. Corn gets mushy about a year out. And pickles turn into pickle-flavored mush very near to their expiration dates. I mean, pickling is nearly synonymous with preservation, and yet …

  12. Throwing away the epipen that goes to school every year is quite annoying.

  13. There is no top-down fix in sight.

    Yes, we know that, we’re libertarians. There has never been a top-down fix.

    1. The “Fix” is already in, from the top down. That’s the problem. The only real fix is freedom. Problem is, it might not work out like we think it will. Let’s give it a shot anyway, huh?

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  15. In a libertarian society there would be no government agency like the FDA. There would be a private agency instead doing the same thing at much less cost.

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