Shelf life: Difference between revisions

Shelf life is not significantly studied during drug development{{dubious|date=February 2012}}, and drug manufacturers have economic and liability incentives to specify shorter shelf lives so that consumers are encouraged to discard and repurchase products. One major exception is the [[Shelf Life Extension Program]] (SLEP) of the [[U.S. Department of Defense]] (DoD), which commissioned a major study of drug efficacy from the FDA starting in the mid-1980s. One criticism is that the U.S. [[Food and Drug Administration]] (FDA) refused to issue guidelines based on SLEP research for normal marketing of pharmaceuticals even though the FDA performed the study. The SLEP and FDA signed a memorandum that scientific data could not be shared with the public, public health departments, other government agencies, and drug manufacturers.<ref>{{cite web |url=http://www.usamma.army.mil/dod_slep.cfm |title=US Army Medical Materiel Agency (USAMMA) |publisher=Usamma.army.mil |date=2013-11-20 |access-date=2014-02-08 |archive-date=2015-03-18 |archive-url=https://web.archive.org/web/20150318065350/http://www.usamma.army.mil/dod_slep.cfm |url-status=dead }}</ref> State and local programs are not permitted to participate.<ref>{{cite web |url=http://www.upmc-biosecurity.org/website/resources/publications/2009/2009-03-27-max_st_local_med_cntr.html |title=Maximizing State and Local Medical Countermeasure Stockpile Investments Through the Shelf-Life Extension Program. |publisher=Upmc-biosecurity.org |access-date=2014-02-08 |url-status=dead |archive-url=https://web.archive.org/web/20130118131537/http://www.upmc-biosecurity.org/website/resources/publications/2009/2009-03-27-max_st_local_med_cntr.html |archive-date=2013-01-18 }}</ref> The failure to share data has caused foreign governments to refuse donations of expired medications.<ref>{{cite web |url=http://www.essentialdrugs.org/edrug/archive/200003/msg00076.php |title=Essentialdrugs.org |publisher=Essentialdrugs.org |access-date=2014-02-08 |url-status=dead |archive-url=https://web.archive.org/web/20131211033851/http://www.essentialdrugs.org/edrug/archive/200003/msg00076.php |archive-date=2013-12-11 }}</ref> One exception occurred during the 2010 [[Swine flu (outbreak in the US)|Swine Flu Epidemic]] when the FDA authorized expired [[Tamiflu]] based on SLEP Data.<ref>{{cite web|url=https://www.fda.gov/newsevents/publichealthfocus/ucm154962.htm |title=Stockpiled Antivirals at or Nearing Expiration |publisher=Fda.gov |access-date=2014-02-08}}</ref> The SLEP discovered that drugs such as [[Cipro]] remained effective nine years after their shelf life, and, as a cost-saving measure, the US military routinely uses a wide range of SLEP tested products past their official shelf life if drugs have been stored properly.<ref>{{Cite web | url=http://www.usamma.army.mil/assets/docs/dlar.pdf {{Webarchive| title=FOREWORD (Supplementation is permitted by the ICP)| archive-url=https://web.archive.org/web/20171209041117/http://www.usamma.army.mil/assets/docs/dlar.pdf | archive-date=2017-12-09 }} {{Bare URL PDF|date=March 2022}}</ref>