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If there’s a number that perhaps best illustrates the unintended consequences of FDA’s Unapproved Drug Initiative (UDI), it’s 1,700—the percentage by which the price of vasopressin, a critical care medication for patients with severely low blood pressure,1 increased following its formal approval in 2014 as Vasostrict.2
The expense already proved a challenge for providers, which was only exacerbated during the COVID-19 pandemic given the number of critically ill patients who required treatment for hypotension. Even as the number of COVID-19 cases has declined, Vasostrict remained the 11th most purchased drug across Vizient member organizations, as identified in our most recent Pharmacy Market Outlook.
With the introduction of generic competition, the price of Vasostrict has now decreased by 25%—a welcome relief for providers, but not even close to the pre-UDI approval level. Based on an analysis of national purchasing data, Vizient estimates that during the intervening seven years of sole source vasopressin, the US healthcare system spent an additional $3.2 billion due to pricing actions taken after the legacy product received formal FDA approval.
While more competitors for this market are expected, the rate at which costs decline is still to be seen.3 Regardless of what happens, vasopressin will remain a stark reminder of the potential consequences when exclusivity awarded far exceeds the investment needed to receive approval.
For the past five years, we have closely monitored those types of financial and clinical impacts of the UDI, which we consider a well-intentioned program in its encouragement of formal FDA review for unapproved legacy medications. But, as with vasopressin, the program inadvertently created financial challenges and access issues for health systems spurred by reduced competition, extended exclusivity and patent protection granted to these drugs even though their approvals contained little to no new clinical trial data.4
Take, for example, dehydrated alcohol, which is commonly used as an “ethanol lock” to protect the access port for vulnerable patients who require infusions via a central venous access device.5 In 2018, FDA approved dehydrated alcohol as the orphan drug Ablysinol for the treatment of a rare heart condition called hypertrophic obstructive cardiomyopathy6 (and granted the drug seven years of market exclusivity). Then, in 2020, FDA requested companies stop distributing unapproved versions of dehydrated alcohol—a move that led the price of Ablysinol to balloon by more than 950% compared to the previously unapproved versions, which have been removed from the market.7 Considering dehydrated alcohol is used to treat far more than a single rare heart condition (and Ablysinol was approved as a new drug even though no new clinical studies were conducted as part of that approval8), the degree of exclusivity is undeniably disproportionate. Even more problematic is that it has created a sustained inability of providers to obtain an adequate supply of dehydrated alcohol in any form.9
While FDA's mission to ensure the safety, efficacy and quality of all pharmaceuticals is an important one—and one Vizient supports—the concern with the UDI has been the disproportionate benefits of exclusivity granted for what appears to be very modest investment in product approval (such as no clinical trials conducted). That exclusivity allows manufacturers to significantly increase prices for sustained periods for products that providers have a long history of using. And, as evidenced by current supply chain metrics, higher-priced products do not always translate into supply chain resiliency.9,10
We support a continuation of ways to advance the application of programs like the UDI to promote greater transparency of regulatory processes, generate additional clinical data where truly needed and ensure access is maintained despite supplier changes.
Steven Lucio, PharmD, BCPS, is Senior Principal, Pharmacy Solutions, and Jenna Stern is Senior Regulatory Affairs and Public Policy Director, both at Vizient.
1. Holt NF, Haspel KL. Vasopressin: a review of therapeutic applications. J Cardiothorac Vasc Anesth. 2010;24:330-347.
2. Medi-Span Price Rx (subscription required). https://pricerx.medispan.com/Refresh/Login.aspx, accessed March 2, 2022.
3. IPD Analytics (subscription required). https://www.ipdanalytics.com/, accessed March 2, 2022.
4. Vasostrict. Drug@FDA: FDA-Approved Drugs. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204485Orig1s000TOC.cfm, accessed March 2, 2022.
5. Mezoff EA, Galloway D, Cole CR. Heightened central line-associated blood stream infection risk during a pandemic. J Pediatr Gastroenterol Nutr. 2020;70:e140-e141.
6. Vasostrict. Drug@FDA: FDA-Approved Drugs.
7. Medi-Span Price Rx.
8 Ablysinol. Drugs@FDA: FDA-Approved Drugs. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/207987Orig1s000TOC.cfm accessed March 2, 2022.
9. Vizient supply chain data.
10. Gupta R, Dhruva SS, Fox ER, Ross JS. 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;23:1066-1076.