Re:The Myth of Drug Expiration Dates
by ekianjo on Wednesday July 19, 2017 @02:49AM
(#14802413)
> expensive medication
Apart from biologic drugs, most small molecule compounds are dirt cheap to produce. So cheap that nobody is even striving to produce them in a cheaper, more efficient way. If you compare this kind of industry with chemical specialty industries, where the mindset is to increase yield as much as possible, in pharma the production cost is not much of a consideration. So, what you pay for your drugs has almost no relationship to how much it costs to produce. You are paying for patents, market exclusivity and the whole system that goes with it (the pharma companies are not the only ones benefiting from it).
> How did they come to an expected shelf-life of 2 years in the first place?
Stability studies supporting 2 years data (submission to approval takes one year, and compiling all data before submission for filing is a 6 months process, so you can start submission with 1 year stability data in your hands, and tell the regulatory agencies you will provide the 2 years data during the second half of the regulatory review to get 2 years).
Because that's good enough for most drugs. 3 years is usually ideal, but not always necessary. If your drug is used in high volume most patients won't get batches that are produced long ago anyway.
Apart from biologic drugs, most small molecule compounds are dirt cheap to produce. So cheap that nobody is even striving to produce them in a cheaper, more efficient way. If you compare this kind of industry with chemical specialty industries, where the mindset is to increase yield as much as possible, in pharma the production cost is not much of a consideration. So, what you pay for your drugs has almost no relationship to how much it costs to produce. You are paying for patents, market exclusivity and the whole system that goes with it (the pharma companies are not the only ones benefiting from it).
> How did they come to an expected shelf-life of 2 years in the first place?
Stability studies supporting 2 years data (submission to approval takes one year, and compiling all data before submission for filing is a 6 months process, so you can start submission with 1 year stability data in your hands, and tell the regulatory agencies you will provide the 2 years data during the second half of the regulatory review to get 2 years).
Because that's good enough for most drugs. 3 years is usually ideal, but not always necessary. If your drug is used in high volume most patients won't get batches that are produced long ago anyway.