Statement on CMS’ Reversal of the Withdrawal of Guidance on the Unapproved Drugs Initiative

By Blair Childs, Senior Vice President, Public Affairs

The Centers for Medicare & Medicaid Services (CMS) and Food and Drug Administration (FDA) should take this opportunity to closely examine the Unapproved Drugs Initiative (UDI) and make needed improvements to the process to ensure that decades-old drugs are still available to consumers at reasonable prices. Premier hopes that the withdrawal is temporary as the administration seeks appropriate public input to determine a safe path forward to prevent unintended consequences of the program such as price gouging and drug shortages. For example, potassium chloride jumped in price from $40.86 in 2015 to $236.93 in 2016 due to the UDI drug pathway. In addition, it created a sole source situation that placed the drug at great risk for shortage.

As the FDA develops guidance on this topic, Premier recommends options for changing the process. These include providing additional notice to manufacturers being forced to exit the marketplace and to providers to allow them to prepare and avoid disruption to patient care. We also call on FDA to fully utilize real-world data and evidence to demonstrate the safety and efficacy for these drugs that have been used in the provision of patient care for decades. Only then will we have a sustainable and attainable solution that will truly impact drug prices and save patients money for safe and effective drug products.