FDA commissioner Scott Gottlieb says a new Drug Shortages Task Force will “delve more deeply into the reasons why some shortages remain a persistent challenge. The charge to this new task force is to look for holistic solutions to address the underlying causes for these shortages.”
The commissioner’s statement says the new task force will expand upon the work of a group created by the FDA Safety and Innovation Act of 2012 that gave the agency new authorities to address drug shortages, including broadening the requirements that manufacturers notify FDA of a permanent discontinuation or temporary interruption in manufacturing that could lead to a shortage of prescription drugs.
“We believe lasting solutions to this issue can’t be addressed by FDA alone,” Gottlieb says. “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. The only way to produce these low-margin products profitably is to manufacture them at tremendous scale. This has resulted in fewer and fewer manufacturers for certain key products. The result is very little margin for error in this space.”
To ensure that any potential solutions are not overlooked, he says, the task force will include leaders from the Centers for Medicare and Medicaid Services (CMS) and the Department of Veterans Affairs, as well as from FDA.
“We intend to establish several dedicated workgroups to look at various aspects of this issue,” the statement says. “These will include an examination of FDA’s current authorities. It will also evaluate the reimbursement policies from CMS and other payors that could be making it difficult for companies to manufacture certain drugs profitably.” It says Gottlieb wants the task force to explore possible incentives to encourage expansion of manufacturing capacity and enhanced quality. It will look at whether it makes sense to develop a critical drugs list or a list of essential drugs. For such medicines, the statement says, FDA may want to consider more significant interventions than it currently employs to avert shortages, such as regulations coupled with financial incentives to market critical access drugs.