Talk:Medication package insert

Image

 * This request was made 03:54, 23 July 2006 by User:Bookgrrl.
 * Most package inserts are available in pdf forms now. They don't really look like much, just pages of small text.  On paper, they're usually printed on large sheets of thin paper, and then folded up so they fit in a box.  If you ask your Favorite Web Search Engine about them, you'll get plenty of examples.  WhatamIdoing (talk) 23:22, 24 May 2010 (UTC)

Catch-22
One of the general controversies for PIs (that is, not related to the PI for any specific medication) is that the manufacturer cannot include statements without the regulatory agency's approval, but can be sued for product liability (in the US, at least) for not providing the same information that the agency prohibited them from providing. It works like this:


 * Drug Co. asks the FDA for permission to include a statement, e.g., that the drug may kill patients.
 * The statistical experts at the FDA decide that the evidence to support this claim is weak, and denies the amendment.
 * Somebody dies.
 * The deceased's heirs sue Drug Co. for complying with the FDA's direction to not publicize the possibility of death. (The jury, of course, will not be composed of statistical experts.)

Drug Co. is, basically, left with a choice between breaking the law, paying damages, or protesting the decision by halting manufacture of the drug if the FDA doesn't let them claim weakly supported side effects. The regulatory agency has a public interest in not allowing the manufacturer to spam every possible side effect into the PI, since it wants prescribers and patients to get useful information (and if the decision were entirely up to the manufacturer's product liability lawyers, then some of them really would list every possible side effect on every single medication).

I know this has been discussed in sources, but I don't have any at hand. If someone else has sources, then perhaps this could be addressed in this article. WhatamIdoing (talk) 23:22, 24 May 2010 (UTC)

External links modified (January 2018)
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 * Added archive https://web.archive.org/web/20060905155817/http://leda.law.harvard.edu/leda/data/85/bschuman.rtf to http://leda.law.harvard.edu/leda/data/85/bschuman.rtf
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 * Added archive https://web.archive.org/web/20101229023019/http://www.orthoelmiron.com/shared/pi/elmiron.pdf to http://www.orthoelmiron.com/shared/pi/elmiron.pdf
 * Added archive https://web.archive.org/web/20060522060505/http://www.rabavert.com/Rabavert_PI_0404.pdf to http://www.rabavert.com/Rabavert_PI_0404.pdf
 * Added tag to http://www.itri.brighton.ac.uk/projects/pills/reports/PILLS_WhitePaper_V2.0.pdf

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merge
In October of 2017 it was proposed that Patient information leaflet be merged into this article. There have been no negative response so the articles have been merged. Pkgx (talk) 16:55, 25 January 2018 (UTC)

Broken link
In: The list of 1997 drug labelling changes can be found on the FDA's website, here. Gevrey (talk) 21:33, 8 June 2022 (UTC)