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FDA Commissioner, Scott Gottlieb, announced formation of a new, drug shortages task force and efforts to advance long-term solutions to prevent shortages.
In response to urging from lawmakers, FDA Commissioner, Scott Gottlieb, announced formation of a new drug shortages task force and efforts to advance long-term solutions to prevent shortages. Despite a decline in drug shortages since 2011 due to efforts by FDA, industry, and other groups, shortages continue, and more must be done, said Gottlieb in a July 12, 2018 statement.
“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,” stated Gottlieb. “… Lawmakers have recently urged us to develop new proposals for the actions that we believe could have a more enduring impact on solving these vulnerabilities. In that spirit, they’ve asked us to consider whether the FDA or other federal agencies may need additional authorities to help ensure that patients have continued access to their medicine. They have also asked us for recommendations on the policy steps we can implement to address the root causes that give rise to shortages. We are taking up this cause.”
The Drug Shortages Task Force will be led by Keagan Lenihan, FDA’s associate commissioner for strategic initiatives. The task force is charged with identifying the reasons why some shortages remain a persistent challenge and to look for holistic solutions to addressing the underlying causes for these shortages. Gottlieb noted that the task force will expand upon the work of the group created by the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA), which broadened the requirements that manufacturers notify FDA of a permanent discontinuation or temporary interruption in manufacturing that might lead to a shortage of prescription 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,” said Gottlieb.
Gottlieb also noted that many drug shortages have been of low-profit margin, generic, sterile drugs. “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,” he explained.
A lack of investment in sterile, injectable manufacturing facilities has also been a cause of manufacturing problems and thus shortages. “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. This is one area we’ll explore,” said Gottlieb. “But we also need to look more broadly across the entire pharmaceutical industry, healthcare providers, payors, and government regulators for structural solutions that keep these shortages from happening.”
Gottlieb said the task force will include senior leaders from FDA and leaders from the Centers for Medicare and Medicaid Services (CMS) and the Department of Veterans Affairs, which provide or pay for prescription medicines.
“We intend to establish several dedicated workgroups to look at various aspects of this issue,” said Gottlieb. “These will include an examination of the 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. I also want the task force to explore possible incentives to encourage expansion of manufacturing capacity and enhanced quality. We’ll be looking at whether it makes sense to develop a critical drugs list, or a list of essential drugs. These are medicines where it would be especially important, from a clinical perspective, to ensure an uninterrupted drug supply. For these medicines, we may want to consider more significant interventions than we currently employ to avert shortages.”
“One possibility might be to look at regulations coupled with additional financial incentives to market these critical access drugs. We want to make sure we aren’t discouraging investment for manufacturing drugs that are more likely to go into shortage, and thus working against our own goals. Among some of the steps that could potentially be considered, and coupled with additional incentives, are requirements for sharing additional key information from industry when they notify the agency about a possible shortage. Another consideration might be to look at whether it could help address shortages to expand the FDA’s authority to require applicants of certain drugs to conduct a risk assessment to identify the vulnerabilities in their drug supply that could cause a shortage, and to establish risk mitigation plans to address those weaknesses proactively,” said Gottlieb.
Gottlieb said that FDA plans to hold a meeting with stakeholders and seek input from the pharmaceutical and healthcare industries, patient representatives, federal partners, and Congress. He also noted that FDA is supporting new technologies to improve manufacturing, and he pointed to the Emerging Technology Team and quality metrics initiatives as examples of current efforts.
“In the meantime, the FDA’s dedicated groups of employees will continue working diligently behind-the-scenes to anticipate and help mitigate shortages. Our drug shortages staff at the FDA’s Center for Drug Evaluation and Research, who are also US Public Health Service Commissioned Corps officers, worked with manufacturers to prevent 145 drug shortages in 2017. That work was on top of a nearly around-the-clock effort, along with other FDA employees, to cope with the aftermath of the 2017 Atlantic hurricanes, which initially shut down several important medical product manufacturing facilities in Puerto Rico, exacerbating shortages of IV saline and other fluids. These dedicated Commissioned Corps officers, collaborating with other colleagues in CDER and across the FDA, worked with pharmaceutical companies to address the shortages by temporarily providing discretion to import products from other facilities and to expedite approval of new manufacturing facilities. They also worked to help expedite the review and approval of similar products from other companies. The important work they do cannot be understated,” said Gottlieb.