The Administration for Strategic Preparedness and Response (ASPR) is actively assessing whether more invocations of the Defense Production Act will be needed to respond to the drug shortage fallout from Hurricanes Helene and Milton, the office told Inside Health Policy. ASPR said it is communicating with Baxter and two additional domestic IV drug makers on whether to take additional action, and is coordinating with FDA on enforcement discretion.
Meanwhile, several lawmakers have written to HHS highlighting the continued difficulty hospitals are facing with reduced allocations of IV fluids, urging HHS to communicate clearly with providers about what steps are being taken to resume production at normal levels.
HHS has invoked the DPA to help drug manufacturer Baxter International clean and rebuild its North Carolina facility, which was impacted by Hurricane Helene, and to address the increased shortages of IV drug products that are continuing to impact hospitals. The department has issued one priority rating to Baxter for remediation material the company was unable to secure and needed to restart production.
An ASPR spokesperson told IHP the office is engaging with Baxter on identifying any other supply challenges that could require priority rating and with two other domestic IV drug manufacturers, ICU Medical and B. Braun, on any materials challenges they face.
“ASPR has identified over 30 potential saline producers to discuss their production needs and ASPR is coordinating with FDA on enforcement discretion considerations,” the spokesperson said.
HHS has undertaken several other efforts to respond to the shortages. FDA has added additional parenteral drug products to its drug shortage list, allowed temporary imports to fill production gaps and released a new guidance allowing increased compounding of IV solution drugs.
In its most recent update on Thursday (Oct. 17), Baxter International said the first product shipments authorized by FDA for temporary importation will arrive in the United States this weekend and projected “nearly 18,000 tons of product from Europe and Asia” will be delivered in the coming weeks.
Baxter said it is pursuing other options to support availability, including expiration date extension requests, and will continue providing updates to customers. “Based on 1) the current status of our remediation efforts, 2) our expectations regarding our ability to reallocate capacity from other Baxter facilities, and 3) initiation of temporary importation on certain products, our goal remains to return to 90% to 100% allocation of certain IV solution product codes by the end of 2024,” the company wrote.
The American Hospital Association (AHA) told IHP the Defense Production Act is one of many tools that can be used to help expand production of drugs in shortage.
“We want and welcome any lever that can be pulled that will advance our ability to get more product into the supply chain, that includes the DPA but we’re in constant conversations with the executive branch on all their efforts to mitigate the shortage,” the group said.
AHA said many of the actions HHS has taken in response to the hurricane are encouraging, but hospitals are still experiencing delays in receiving their reduced allocations of drugs, possibly in part due to the timeline for receiving drugs from temporary importers.
“The impact varies from hospital to hospital so we’re monitoring carefully to ensure that allocations that were promised meet the reality on the ground,” AHA said. “This is especially important in the weeks and months to come as we enter flu and respiratory virus season where the need is greater. In the meantime, hospitals are working overtime to ensure patient safety is not impacted and engaging in all the conservation methods available and necessary.”
Tom Kraus, vice president for government relations at the American Society of Health-System Pharmacists (ASHP), told Inside Health Policy Wednesday (Oct. 16) that products under limited allocations are still leading to canceled elective surgeries at hospitals. But Kraus said the federal government has been taking many of the actions ASHP encouraged in response to the shortage, like exercising flexibility on compounding, declaring a public health emergency and engaging with the Federal Trade Commission to discourage price gouging.
Kraus applauded HHS for taking steps to proactively protect the IV drug producer B. Braun from the possible impact of Hurricane Milton and for using DPA authorities to help rebuild the North Carolina Baxter facility.
He said there are no other obvious actions HHS should take under DPA for now, but added that he has heard some reports of shortages of IV kits, which include materials needed to infuse drug products. If those products do enter shortage, Kraus said, use of DPA authorities to allocate them to essential medical uses rather than other facilities, like wellness clinics, could be necessary.
The Alliance for Pharmacy Compounding is among stakeholders who have criticized FDA’s shortage list and pointed to ASHP’s own list, which includes information from a broader range of sources, as a better alternative. Kraus agreed that ASHP could benefit from using a wider universe of information on shortages. But he also noted that FDA’s drug shortage response team consists of just a few people, which limits what the agency can do.
“FDA’s shortage team has very limited resources. Having more resources for FDA to manage shortages would be helpful in the long term,” he said.
On Thursday, Sens. Mark Warner and Tim Kaine (both D-VA) joined Sens. Mark Kelly (D-AZ), Kyrsten Sinema (I-AZ) and Bob Casey (D-PA) in sending a letter to HHS Secretary Xavier Becerra on the continued challenges hospitals are facing following the hurricanes.
“After orders were recently canceled, some providers have reported having only single-digit days’ worth of product on hand, while others are utilizing over-the-counter oral hydration solutions like Gatorade--and fear reduced allocations of those alternatives as well,” the senators wrote. “While providers are seeing promising results from HHS’s actions so far, we must ensure this progress continues.”
The lawmakers urged HHS to “provide clear and continuous communication to health providers on their options and the path forward as communities recover from this storm and any impact that may stem from Hurricane Milton.” They also said HHS should conduct “intentional outreach to safety net, tribal, and rural providers, as well as those caring for vulnerable populations who may lack the resources to sustain prolonged shortages.” -- Jessica Karins (jkarins@iwpnews.com)