The Biomedical Advanced Research and Development Authority (BARDA) might have more money in store for U.S. pharmaceutical producers. If there is one thing the recent SARS2 pandemic showed us all, it was that weak, offshore-reliant supply chains were a detriment to public health and safety. In fact, three years into the pandemic, and the U.S. is still lacking critical medications used to fight Covid. Most recently, amoxicillin is in short supply. The antibiotic is used for those with Covid pneumonia, among other things.
This week, BARDA held a two-day conference and some panels focused on ways the U.S. Department of Health and Human Services (HHS), of which BARDA is a part, will be working with private, American labs going forward.
From the panel Establishing the Biopharmaceutical Partnership on Wednesday, Tim Belski, Branch Chief for BioMaP at BARDA, which is the new National Pharmaceutical Manufacturing Partnership. It launched in June 2021.
Belski is tasked with developing the BioMaP initiative in order to “build the domestic infrastructure, manufacturing platforms, and supply chain capacity” mostly for vaccine production during public health emergencies – but not limited to vaccines. If the drug is something that is needed to fight a public health emergency, whereas hundreds of thousands of lots are needed, then that, too, would fall under the purview of BARDA support.
Belski said BARDA was still drafting all the acquisition documentation and formatting to get started working with local pharmaceutical companies capable to handle surge production. “We hope to get this on the street pretty soon,” he said. “We are getting pretty close to nailing it down so we can move forward.”
Belski said that the HHS health officials “do not want to use the Defense Production Act all the time” to make up for supply holes. But, noted that “the more we can expand our local supply chains the better off we are going to be in the next pandemic.”
Although the focus was on vaccines, Belski said, “If we don’t need 300 million doses of it, we don’t need it as a BioMaP partner. But if it is being developed for a pandemic response, then it is something we should look at and see how it fits in our program.”
How much funding from Congress? Belski wouldn’t say. A lot is riding on the renewal of the March 2022 Advanced Research Projects Agency for Health (ARPA-H) law. That law expires in September.
Congressional Leaders Expect Funding
Rep. Ann Eshoo (D-CA-18) spoke at BARDA Industry Day on Wednesday. Eshoo wrote the law that created BARDA. She authored some 41 bills that were signed into law, with more than half of them related to the health industry.
“We need to enhance our supply chain security and need better stockpiling management and need to increase capacity here,” she said, something Eshoo has repeated in hearings on this subject for years, though little movement has been done in this direction.
Maybe this Congress will be different? “Securing American supply chains is important to me in the 2023 ARPA legislation,” she said.
Rep. Richard Hudson (R-NC-8) also spoke on Wednesday. He serves as on the House Health Sub-Committee and co-chairs a Congressional biodefense caucus.
“I am optimistic we can get big things done in the next Congress. ARPA is top issue,” Hudson said.
“We need private partnerships. They are critical to successful public health. We need to promote these partnerships in going ahead with ARPA reauthorization. Last summer, Kevin McCarthy (new Speaker of the House for 2023) created six task forces where all the Republicans in our conferences got together to plan for the eventuality of being in charge of the House and I was put in charge of health security. We have solicited feedback from private industry sources on how to strengthen our supply chains. Our goal is to assure we are ready for the next emerging health threat. One major theme we heard from companies was to make sure HHS and other agencies were incentivizing the private sector. We need to provide long-term contracts; we need clarity and sustainability to allow American labs to plan ahead and we in government have to continually engage, so we can ramp up in case of another health emergency. I encourage you all to engage with members of Congress and our staff.” — Rep. Richard Hudson, BARDA Industry Day, November 16, 2022
BARDA is responsible for the procurement and development of medical countermeasures, principally against bioterrorism, including chemical, biological, radiological, and nuclear threats, as well as pandemic responses and preparedness.