The Unapproved-Drugs Initiative Is Coming to an End

References

1. Department of Health and Human Services. Termination of the Food and Drug Administration’s Unapproved Drugs Initiative; Request for information regarding drugs potentially generally recognized as safe and effective. 85 Fed Reg. 2020 Nov 25;75,331. .
2. Gupta R, Dhruva SS, Fox ER, et al. The FDA Unapproved Drugs Initiative: An observational study of the consequences for drug prices and shortages in the United States. J Manag Care Spec Pharm. 2017 Oct;23(10):1066–1076.
3. Staff. FDA enforcement against injectable colchicine. The Rheumatologist. 2008 May 1.
4. Quinn R. Generic colchicine approved for gout prophylaxis. The Rheumatologist. 2015 Mar 1.
5. Frequently asked questions regarding the Department of Health and Human Services’ announcement on the Unapproved Drugs Initiative. Department of Health and Human Services.
6. Vizient. Vizient analysis shows ending Unapproved Drugs Initiative could save between $7.52 billion and $26.59 billion. 2020 Nov 23.
7. Carico RL, Emmendorfer TR, Aspinall SL, et al. Review of purchases of unapproved medications by the Veterans Health Administration. Am J Health Syst Pharm. 2019 Nov 13;76(23):1934–1943.