FDA creates task force to combat drug shortages
- Food and Drug Administration head Scott Gottlieb has formed a new task force to try to minimize the impact of drug shortages on patients and physicians. This will focus on creating long-term solutions to the "underlying structural concerns that give rise to these recurring challenges."
- The role of the task force, led by Keagan Lenihan, the agency’s associate commissioner for strategic initiatives, has been charged by Gottlieb to look into why some shortages remain an issue.
- The task force will include senior leaders from the FDA, the Centers for Medicare and Medicaid Services and the Department of Veterans Affairs. The next step will be to engage with the public, and hold a meeting with stakeholders.
New drug shortages in the U.S. have been steadily declining since a peak in 2011. However, in 2017, The Food and Drug Administration tracked more new drug shortages than in either of the two previous years. These disruptions followed issues at a Pfizer manufacturing plant in Kansas, and a damaging hurricane season wiping out facilities in Puerto Rico. While last year may be an aberration, the FDA announced its commitment in June to mitigating existing issues and preventing new ones from occurring.
Work on tackling drug shortages began with the 2012 FDA Safety and Innovation Act (FDASIA), which broadened the requirements for manufacturers to notify the FDA of temporary or permanent hold-ups in production of drugs for serious illnesses.
"Being notified of these issues has been critically important. It has allowed the FDA to work with manufacturers to address and prevent hundreds of shortages in the past few years," Gottlieb said in a statement.
The task force will look at different factors, including the FDA'S current authorities, payer reimbursement policies and incentives to encourage investment in manufacturing. The task force may also consider setting up a a list of essential drugs, so that supply and shortages of these drugs would be managed more closely, or carry greater incentives.
One of the key challenges in drug shortages is around low profit margin generic drugs, including sterile parenteral products. The availability of these can be critical for patients, but lack of profit and the challenges in manufacturing have led to consolidations in the industry. Limited returns may also mean manufacturers are less likely to invest in production facilities, increasing the risk of shortages.
"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," said Gottlieb.
This reduction in numbers of manufacturers and the increased risk of stoppages leaves little room for error — if one company has a delay or stop in the manufacturing process, it has a huge effect on the supply chain.
"I believe long-term solutions must include those that encourage companies to invest in more capacity to make these important medicines, and to produce them with robust manufacturing processes that ensure consistently available quality products," said Gottlieb. "The FDA is already taking steps to support new technologies that can improve manufacturing and help reduce the chance that supply disruptions will occur."
Some drug shortages are also caused by issues beyond anyone's control. As Gottlieb noted, the 2018 hurricane season is under way. Federal agencies, including the FDA’s Emergency Operations Center, are monitoring storms, and identifying FDA-regulated facilities that could be impacted. The monitoring will mean that the agency can respond more quickly to any potential storm-related drug shortages.
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