The United States Food and Drug Administration (FDA) recently announced the creation of a new drug shortage task force, led by Keagan Lenihan, the FDA’s associate commissioner for strategic initiatives. The task force, created in response to certain shortages continuing to remain a challenge for extended periods of time, even as the number of new drug shortages has steadily declined since 2011.
The task force will include senior leaders from the FDA, the Centers for Medicare and Medicaid Services (CMS), and the Department of Veterans Affairs (VA). These three agencies collectively provide or pay for prescription medications for millions of Americans.
The task force will expand upon the work of a group that was created by the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA). FDASIA gave the FDA new authorities to address drug shortages, including broadening the requirements that manufacturers notify us of a permanent discontinuation or temporary interruption in manufacturing, which might lead to a shortage of prescription drugs for serious illnesses. The FDA being notified of these issues has been critically important, as it has allowed the agency to work with manufacturers to address and prevent hundreds of shortages in the past few years.
Historically, many drugs in short supply have been low-profit margin generic medicines. Many are sterile, parenteral drugs, which can be challenging to manufacture. The low-profit margins, and the significant cost of manufacturing these complex drugs, has resulted in consolidation in the industry. According to FDA Commissioner Scott Gottlieb, “the only way to produce these low-margin products profitably is to manufacture them at tremendous scale.”
FDA Commissioner Gottlieb released a statement, where he noted “While we’ve made progress to mitigate individual shortages, we haven’t firmly impacted the underlying structural concerns that give rise to these recurring challenges. When shortages occur, practitioners are forced to ration supplies or substitute alternate drugs that in some cases compromise patient care. We need to pursue more enduring solutions.”
In addition to the task force, Commissioner Gottlieb intends to establish several dedicated workgroups to look at various aspects of the issue. These workgroups will focus on: an examination of the FDA’s current authorities; evaluating the reimbursement policies from CMS and other payors that could be making it difficult for companies to manufacture certain drugs profitably; exploring possible incentives to encourage expansion of manufacturing capacity and enhanced quality; and whether it makes sense to create a “critical drugs list,” comprised of medicines where it would be especially important from a clinical perspective to ensure an uninterrupted drug supply.
Commissioner Gottlieb also noted that “the task force will not be operating in a vacuum” and that the FDA plans to engage the public and hold a meeting with stakeholders in the next several months to provide an opportunity for everyone with a stake in addressing drug shortages to come to the table. The Agency also looks forward to any input from lawmakers and will consider how additional authorities from Congress might help better address shortages.