TABLE 3.
Average Wholesale Unit Price of Previously Unapproved Prescription Drugs 2 Years Before and After UDI Regulatory Action or Voluntary Approval (N = 26) and Unit Price of Specific Manufacturers’ Drug Products Immediately Before and After (N = 10)a,b
| Year of UDI Compliance or Voluntary Approval | Unit Price Before, $ | Unit Price After, $ | Change in Unit Price, % | Manufacturer Unit Price Before, $ | Manufacturer Unit Price After, $ | Change in Unit Price, % | |
|---|---|---|---|---|---|---|---|
| Overall, median (IQR) | 0.74 (0.23-2.63) | 1.24 (0.46-6.20) | 37 (23-157) | 1.51 (0.57-2.98) | 4.05 (1.01-14.40) | 122 (10-351) | |
| P value | < 0.001 | 0.013 | |||||
| Drug | |||||||
| Atropine sulfate ophthalmic solution | 2014 | 3.42 | 3.88 | 13.3 | 2.22 | 6.35 | 186.6 |
| Balanced salt solution (ophthalmic) | 2008 | 0.17 | 0.18 | 6.1 | – | – | – |
| Codeine phosphate combinations | 2014 | 0.80 | 1.11 | 37.8 | – | – | – |
| Codeine sulfate tablet | 2010 | 0.43 | 0.46 | 5.8 | – | – | – |
| Colchicine tablet | 2010 | 0.33 | 5.82 | 1,663.6 | 0.17 | 5.82 | 3,323.5 |
| Dihydrocodeine bitartrate combinations | 2014 | 2.63 | 3.36 | 27.8 | – | – | – |
| Epinephrine injection/syringe | 2010 | 0.49 | 1.15 | 136.2 | 1.44 | 2.28 | 58.3 |
| Ergotamine-containing product | 2007 | 107.38 | 138.60 | 29.1 | 1.58 | 1.89 | 19.6 |
| Fluorescein injection | 2012 | 6.60 | 8.94 | 35.5 | – | – | – |
| Hydrocodone | 2007 | 0.20 | 0.26 | 26.2 | – | – | – |
| Hydromorphone injection | 2011 | 1.20 | 1.34 | 11.7 | 1.10 | 1.01 | -8.7 |
| Hydromorphone tablet | 2009 | 0.67 | 0.85 | 26.8 | – | – | – |
| Levothyroxine injection | 2006 | 7.20 | 18.00 | 150.0 | 50.93 | 180.00 | 253.4 |
| Morphine sulfate immediate-release tablet | 2009 | 0.18 | 0.20 | 9.3 | – | – | – |
| Morphine sulfate injection | 2011 | 0.23 | 0.59 | 154.3 | 0.47 | 0.48 | 2.1 |
| Morphine sulfate solution | 2010 | 0.08 | 0.08 | 4.5 | – | – | – |
| Nitroglycerin sublingual tablet | 2010 | 0.15 | 0.19 | 23.3 | – | – | – |
| Oxycodone immediate-release tablet | 2009 | 0.35 | 0.80 | 128.6 | 0.57 | 0.61 | 7.0 |
| Oxycodone solution | 2010 | 1.15 | 5.55 | 382.6 | – | – | – |
| Pancrelipase | 2010 | 0.46 | 0.70 | 51.1 | – | – | – |
| Phenylephrine hydrochloride (IV solution) | 2012 | 2.98 | 14.40 | 383.2 | 2.98 | 14.40 | 383.2 |
| Phenylephrine hydrochloride (ophthalmic solution) | 2013 | 1.68 | 7.50 | 346.4 | – | – | – |
| Pilocarpine hydrochloride ophthalmic solution | 2012 | 1.94 | 6.20 | 220.4 | – | – | – |
| Potassium chloride oral solution | 2014 | 0.02 | 0.05 | 222.6 | – | – | – |
| Quinine | 2007 | 3.31 | 4.06 | 22.7 | – | – | – |
| Vasopressin | 2014 | 2.18 | 134.20 | 6,069.9 | 5.13 | 59.40 | 1,057.9 |
aUnit prices are reported, which are per gram, per milliliter, or per piece (e.g., pill) because some drugs in the sample are consumed daily, whereas others are taken as needed; manufacturer-specific analyses are focused on the manufacturers to which the FDA sent UDI warning letters or that were labeled as previously “marketed without an approved NDA” in Drugs@FDA.
bThere were 8 drugs for which no pricing data were available during the 2 years before and after UDI regulatory action or voluntary approval: carbinoxamine, codeine phosphate injection, colchicine injection, Freshkote ophthalmic solution, otic drugs, papain-containing topical drugs, sodium nitrite and sodium thiosulfate injection, and trimethobenzamide hydrochloride suppository.
FDA = U.S. Food and Drug Administration; IQR = interquartile range; IV = intravenous; NDA = New Drug Application; UDI = Unapproved Drugs Initiative.