Beyond that, what is the incentive on the part of the company? No one is evaluating medications based on shelf life. Longer expiration dates -at best- do nothing favorable for the company, and at worst both reduce the purchase of more of the drug, -and- open the company up to litigation in the even it's dangerous. Why take that risk? There is simply no economic pressure to.
I would assume there's also liability to think about. If something goes wrong with a medicine after the expiration date it has to be better for the manufacturer. Also you probably want to leave some room for suboptimal storage
Yea, prescription drug manufacturers have little incentives to seek multi year shelf lives. Combined with the slow approval process real time testing is likely considered sufficient.
I'm sure there is some degree of companies wanting expiry to be like the dates on grocery items that are really "taste best by" dates but in speaking to manufacturing and development people their are some layers of complexity. Compounds do degrade over time in many cases and things like light, temperature and humidity play a role. In pharmacy warehouses they aren't just required to control climate they have to log temperature 24 hours a day in an auditable format. Because of these factors the target is a moving one and while many things would likely be fine, for prescription medicine the tolerance for risk is so low that it pushes things in a very conservative direction.
There is a great comment farther down about how complex label changes can be. Getting a revised label, or packaging through FDA is an enormous undertaking. This why sometimes dosing seems very weird. If research says we need a 2mg and a 4mg but later in the process patients need a .5mg it's a big mess.
Nobody said they need to find the absolute last day the drug expires before they can get it to market.
If it's a new drug and they can only say for sure that it lasts 6 months then put that on the label and ship it out. But assuming the drug will be out for 10+ years they should be continually testing the expiration date and updating as they've had more time to make that determination.
But like I said initially (and as you nicely pointed out) that costs money so why bother?
Even if it didn't cost a dime, some drug companies might not be interested in longer expiration dates. If the expiration date is passed, and you throw it out, you'll have to buy a new supply. More profit!
It's a perverse effect, but that's the way it is.
The main problem is that there just isn't data on how much these drugs degrade. The expiration date is based on some preliminary measurements and conservative guesstimates. Neither the FDA nor the drug companies really cares or wants to see these dates extended.
I worked on expiration dates studies in pharma. It's well known that you could probably always extend the shelf life to 3-4 years for most drugs that are supposed to expire within 2 only, because tablets for example tend to be very stable.
But nobody wants to run long stability studies, because that costs a lot of money (i.e. several batches that have to be analyzed in regular basis, documented, reported, QA'ed, inspected, etc... - and you need to place them in numerous conditions, too, ambient temperature as well as stressed conditions depending on where you intend to market the drug), and bring very little returns at the end of the day. You'd rather want your engineers to work on developing new formulations and regulatory teams to spend time on the application of new drugs rather than adding one or two years of shelf life to an existing drug on the market.
Also know that you can't "extrapolate" and need actual data based on regulations of the big 3 geographies (US, Europe, Japan). So "models" are not accepted. Also, these agencies are extremely conservative when it comes to what impurities should be considered acceptable and at what levels they should be. Not saying they are necessarily wrong, but this is another constraints. I have seen cases where it was difficult to extend one drug's shelf life because of a single impurity being a little over the tolerated limit.
It seems like this would be true if everything were working perfectly and there was a gradient of purchasing options across price/expiration. As it is consumers really don't have any choice wrt expiration date since as far as I'm aware the option to pay more for longer lasting drugs doesn't really exist.
Seems simple enough, just extend the expiration dates on the meds that don't turn toxic and that still work.
The issue here though is that it's not in the drug manufacturers interest to have super long dates. Putting labels that expire sooner means they can push higher volume.
Your logic would be fine if manufacturers were required to replace expired pills with new ones. But they aren't, so early expiry dates impose enormous economic costs on consumers of drugs, while manufacturers get the massive benefits of selling drugs twice to same consumer.
A big chunk of this article's message is that those considerations seem to not have anywhere near as much of an effect as currently assumed. (EpiPens viable 50 months past their marked date)
I would push two prongs: reinforce that expiration dates are serious, and at the same time test and extend any/all dates to the actual behavior of each drug. turn a one year into 5, 10, 20? Hell yes.
Pretty obvious that big chunks of the health care system are rigged for profit, not efficiency or usefulness.
If scientists are able to calculate the longevity of chemicals, food, and other products without having to wait the actual time period, I don't see how or why pharmaceutical drugs would be any different.
It's very likely it is not favorable to companies to look into this, just as it was revealed that the EpiPen expiration date was not really true.
(former pharmaceutical developer here). This article makes it sound like there's a big conspiracy, which there isn't.
A very few drugs (like erythromycin) become toxic so should be discarded.
Some drugs become less efficacious over time, but nobody really knows the shape of the curve as they are simply tested to see if they have the same efficacy on day E as they did on day 0. Well of course all drugs will become worthless as t approaches 8 but you can guess that since tablets have a very low moisture content, if they are kept in a cool dark place it's likely they'll last a very long time. I also happily keep expired drugs in a controlled environment and use them; all drugs in my car's and backpack's first aid kits get replaced annually because they are exposed to harsh environments.
(Stockpiling drugs doesn't prove anything BTW: if you are stockpiling them against an emergency the presumption is that some efficacy is better than none).
Nobody is going to do accelerated life testing beyond what they have of course. I think extending the required lifetime is a good idea, though I question the size of the economic return claimed in the article.
The expiration dates on food are slightly more scandalous: the FDA doesn't require the same level of testing as they do on the medical side so they are mainly set stupidly short. Last week purchased some vacuum-packed lamb that had a manufacturer label with an expiration date a month away, but was prominently labeled to expire this week. And of course US egg producers take steps that reduce the storage time of eggs, which can be months old when you get them -- and then "expire" a week after getting home.
I work for a company that has some periphery exposure to FDA-regulation, and as a result we have to do a lot of very similar scientific calculations to satisfy their archival records. A big part of why most medicines still expire (at least for medicines available over the counter) much earlier than they should is that a majority of the testing is done to determine the expiration date at a controlled temperature, pressure, and humidity.
They test how it degrades under stress to determine a maximum viability under perfectly stable conditions. They are not accounting for the typical medicine storage places: a bathroom cabinet where the temperature and humidity will vary wildly within a matter of minutes, a cool, damp fridge, or even the reading table next to your bed-- constantly exposed to UV light from the windows.
I'm relaying this secondhand from a former FDA contractor, but I can only surmise that for a company with the litagative risk level that any pharmaceutical entity incurs, the old adage of "Better Safe Than Sorry" is a major part of the story that's missing here.
> The findings surprised both researchers: A dozen of the 14 compounds were still as potent as they were when they were manufactured, some at almost 100 percent of their labeled concentrations.
What kind of reporting is this? Anything less than 100% is not "as potent as when manufactured", and the sentence implies some of those dozen weren't close to 100%.
> The idea that drugs expire on specified dates goes back at least a half-century, when the FDA began requiring manufacturers to add this information to the label. The time limits allow the agency to ensure medications work safely and effectively for patients. To determine a new drug’s shelf life, its maker zaps it with intense heat and soaks it with moisture to see how it degrades under stress. It also checks how it breaks down over time. The drug company then proposes an expiration date to the FDA, which reviews the data to ensure it supports the date and approves it. Despite the difference in drugs’ makeup, most “expire” after two or three years.
That seems to be the problem. There was a procedure in place to set expiration dates scientifically, and it was ignored for some reason, limiting the legal shelf life of even the most stable compounds to a few years.
There's also the not-irrelevant issue that testing is slow and potentially other than free. How do you find out when a drug expires? You have a bunch of it sit around and test it periodically, right?
I assume that would be done after bringing a drug to market, otherwise drugs could easily be delayed 10+ years if they're shelf-stable.
According to the FDA, the manufacturers are doing ongoing stability testing, and as they find the tests are still effective after the date they initially estimated, they can contact the FDA to share their results and request that the FDA authorize a longer shelf life. This actually costs the manufacturer money since they'd be paid when people replaced the "expired" product they threw away, but they're doing it anyway because not everything is a weird conspiracy (and maybe also because the most shelf stable products have an advantage when it comes to what people order for their stockpiles)
This is actually a huge deal. Insulin is famous for lasting several times the listed shelf life if properly refrigerated, but people unaware of this still throw away unfinished vials. Other drugs are so stable they may never expire, so the dates on the bottles are completely arbitrary.
I'm not sure how it would be any different than existing expiration dates for OTC medicines, food, dairy, etc. In the case of medication, it is most likely to become less effective over time rather than toxic.
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