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HelixTalk Episode #89 - Teaching Old Drugs New Tricks: Dramatic Drug Price Increases with the FDA Unapproved Drugs Initiative

Date posted: January 1, 2019, 6:00 am

In this episode, we will review the FDA’s Unapproved Drugs Initiative and how it has impacted the availability and pricing of commonly used (but old) medications, such as colchicine and vasopressin.


Key Concepts

  1. Over the past 100+ years, the Food and Drug Administration has evolved from requiring drugs to not be adulterated/misbranded, to requiring evidence of safety, to now requiring evidence of efficacy.
  2. About 2% of the drugs in the United States are “unapproved drugs”, meaning they were never approved by the FDA for efficacy and safety.  These drugs have been targeted by the FDA’s Unapproved Drugs Initiative to either demonstrate evidence of efficacy and safety or be removed from the market.
  3. Via the Unapproved Drugs Initiative, some older drugs have achieved FDA approval causing either drug shortages or substantial price increases for the consumer.  In some cases, the manufacturers have added little or no new clinical trial data to support their New Drug Application.
  4. Clinicians can verify whether a drug is an FDA-approved drug by using the Drugs@FDA website.  The presence of an NDC number, package insert, or entry in DailyMed does not guarantee the drug is FDA approved.


  • Giouroukakis M, Dryer M. Unapproved drugs--the drug information pharmacists' perspective. J Pharm Pract. 2013 Apr;26(2):112-9. doi: 10.1177/0897190012474234.
  • 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. doi: 10.18553/jmcp.2017.23.10.1066.
  • Ballentine C. Sulfanilamide Disaster. U.S. Food & Drug Administration. Published June 1981. Accessed Nov 6, 2018.
  • Drugs@FDA website to confirm a product is FDA approved: