To reduce the cost to the military of maintaining stockpiles of certain pharmaceuticals, the United States Department of Defense and the Food and Drug Administration operate a joint initiative known as the Shelf-Life Extension Program (SLEP), which evaluates the long-term effectiveness of medications stockpiled by the DoD and other government agencies. The program was established in 1986. [1]
Under the program, medications are tested for safety and stability for extended periods of time in controlled storage conditions. In many cases, medications remain effective for years after their printed expiry dates; a 2006 study published in the Journal of Pharmaceutical Sciences found that two-thirds of 122 medications tested through SLEP remained effective for an average of at least four additional years.[2] 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.[3] In 2023, the DoD reported that the program had helped save the department $1.3 billion on replacing stockpiled medications.[4]
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.[5] State and local programs are not permitted to participate.[6] The failure to share data has caused foreign governments to refuse donations of expired medications.[7] One exception occurred during the 2010 Swine Flu Epidemic when the FDA authorized expired Tamiflu based on SLEP Data.[8]
References edit
- ^ "Expiration Dating Extension". U.S Food and Drug Administration. 2023-04-27. Retrieved 2023-05-09.
- ^ Lyon, Robbe C.; Taylor, Jeb S.; Porter, Donna A.; Prasanna, Hullahalli R.; Hussain, Ajaz S. (July 2006). "Stability profiles of drug products extended beyond labeled expiration dates". Journal of Pharmaceutical Sciences. 95 (7): 1549–1560. doi:10.1002/jps.20636. PMID 16721796.
- ^ http://www.usamma.army.mil/assets/docs/dlar.pdf Archived 2017-12-09 at the Wayback Machine [bare URL PDF]
- ^ "The Myth of Drug Expiration Dates". ProPublica. 2017-07-18. Retrieved 18 July 2017.
- ^ "US Army Medical Materiel Agency (USAMMA)". Usamma.army.mil. 2013-11-20. Archived from the original on 2015-03-18. Retrieved 2014-02-08.
- ^ "Maximizing State and Local Medical Countermeasure Stockpile Investments Through the Shelf-Life Extension Program". Upmc-biosecurity.org. Archived from the original on 2013-01-18. Retrieved 2014-02-08.
- ^ "Essentialdrugs.org". Essentialdrugs.org. Archived from the original on 2013-12-11. Retrieved 2014-02-08.
- ^ "Stockpiled Antivirals at or Nearing Expiration". Fda.gov. Retrieved 2014-02-08.
External links edit
- DoD/FDA Shelf Life Extension Program
- SLEP - The DOD/FDA Shelf Life Extension Program
- SLEP information paper
- Other studies