Experts Weigh in on Planned FDA Drug Shortages Task Force

July 19, 2018

FDA, CMS, and Department of Veterans Affairs experts will be included. Dr. Robin Zon, a past chair of ASCO’s Government Relations Committee, said it is “critical” that the FDA work with providers and patients.

The US Food and Drug Administration (FDA) plans to create a Drug Shortages Task Force to address ongoing production shortfalls and prevent future manufacturing disruptions.

The number of drug shortages peaked in 2011 and has declined since then, but Hurricane Maria and other issues have led to ongoing shortages in “medically necessary products” like medical saline (sodium chloride) and dextrose, noted FDA Commissioner Scott Gottlieb, MD, in announcing the task force.

“Even shortages of a small number of key drugs can place a serious burden on providers,” Gottlieb said. “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.”

Under pressure from lawmakers, Gottlieb created the task force to “look for holistic solutions to addressing the underlying causes for these shortages,” he said.

“I am absolutely thrilled,” said Erin Fox, PharmD, of the University of Utah Drug Information Service. “Everything’s on the table now to push for solutions.”

The task force will be led by FDA’s associate commissioner for strategic initiatives, Keagan Lenihan, and will include experts from three federal agencies: the FDA, the Centers for Medicare and Medicaid Services (CMS) and the Department of Veterans Affairs. It is not yet clear whether or not professional medical or patient organizations will be invited to participate. Lenihan was a political appointee at the US Department of Health and Human Services (HHS) under former HHS Secretary Tom Price.

The task force should include stakeholders as well, said Robin Zon, MD, FACP, of Michiana Hematology Oncology in Mishawaka, Indiana. Zon is a past chair of the American Society of Clinical Oncology (ASCO) Government Relations Committee.

“We definitely welcome the creation of the task force and look forward to learning more,” Zon said. “It is critical, though, that the FDA work with providers and patients. This is not just a manufacturer problem. There are vendors involved and other folks in the supply chain before the drug gets to the provider to give to the patient.”

With its expanded oversight authority under the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA), the FDA had already expanded notification rules for industry, requiring manufacturers to notify the government of impending product discontinuations and production interruptions that could cause or exacerbate clinical product shortages. That has allowed the agency to take preemptive steps to prevent “hundreds” of shortages over recent years, Gottlieb claimed.

The FDA can allow importation of medical supplies from other countries but lacks the legal authority to tell manufacturers how many production facilities to build, or where, for example. Nor can the agency force companies to continue manufacturing generic sterile injectable or parenteral drugs that offer low profit margins. Large-scale production is the only way to make such products profitable, and this has led to consolidation and a dwindling number of manufacturers of key products such as small-volume IV fluid bags used in chemotherapy and supportive care.

Headlines have focused on “the basics,” Fox said: saline and dextrose shortages.

“Saline got a lot of attention but there’s PVC/DEHP-free bags for preparing a lot of chemotherapy doses. What didn’t make the news was how short supplies of those bags had become,” Fox said.

An opioids shortage is also having a significant impact on pain management among patients with cancer, Fox added.

Low profit margins have also led some manufacturers to under-invest in quality control at production facilities, leading to FDA interventions and production interruptions.

The task force is a welcome next step, said Maryann Amirshahi, MD, PharmD, MPH, at MedStar Washington Hospital Center in Washington, DC.

“There was some progress made with FDASIA, but there were some significant shortcomings, and drug shortages remain a major public health problem,” Amirshahi said. “Sustainable solutions cannot happen by FDA interventions alone. They will have to [result from coordination] with other groups such as CMS. CMS is a major payer for prescription drugs, and current reimbursement structure does not favor the manufacture of some products due to low profit margins. These organizations will have to work together to promote manufacturing redundancy without the unintended consequence of increasing healthcare costs.”

In September 2017, Hurricane Maria damaged Baxter International’s saline-manufacturing facility in Puerto Rico, “acutely worsening” a preexisting shortage, Amirshahi explained.

Baxter’s plant was one of three major US medical saline-production facilities. Another plant was dealing with quality-control problems at the time.

“There was not enough redundancy in the supply chain to compensate when Maria hit,” Amirshahi said. “In addition, when there is a quality problem at a specific facility, it is costly and it takes time to bring [the facility] into compliance.”

The timing could not have been worse. In the months after Hurricane Maria, the influenza season was unusually bad, driving up hospital demand for saline.

“We shouldn’t build drug factories in the middle of hurricane alleys, maybe,” Fox said. “We’re coming up on another hurricane season here. Fingers crossed it’s not a bad one, because it’s scary to think about things not being back to where they were if, possibly, new problems arise.”

Baxter’s Puerto Rico facility is now back online and the saline shortages are improving for hospitals.

“But the supply chain for saline remains fragile due to a lack of redundancy in the manufacturing system,” Amirshahi was quick to caution.

“FDA can’t dictate where and how manufacturers build,” Fox said. “Talking to Baxter, their main strategy for redundancy is to have the rest of their plants around the world be FDA-approved so that they could ship products from Ireland or another country.”

FDA allowed temporary importation from Ireland, Australia, and elsewhere, but Baxter wants to see that become permanent, Fox said.

“But that wasn’t enough, though-that strategy didn’t fully prevent the shortage from happening,” Fox explained. “We need manufacturers to build more capacity and redundancy.”

The current trade dispute between the United States and China might impact raw materials for drug manufacturing, which, in turn, could drive up costs and exacerbate shortages, she said.

Congress could offer tax relief or market exclusivity to manufacturers to help alleviate the underlying causes of drug shortages, Amirshahi believes.

“They could also expand FDA’s authority,” she said. “At the same time, we have to be careful that these incentives and policy changes do not have the unintended effects of increasing healthcare costs or precipitating more shortages if manufacturers value the incentives more than current profits.”