B. Braun makes $1B investment in IV fluids

Pharmaceutical manufacturer B. Braun Medical is investing $1 billion in new and expanded facilities that produce and distribute IV solutions as it aims to mitigate drug shortages.

Bethlehem, Pa.-based B. Braun plans to build a new manufacturing and distribution facility in Daytona Beach, Fla., and update and expand its existing facilities in Irvine, Calif., and Allentown, Pa., where it produces saline, heparin, electrolyte solutions and other fluids. It will also expand its distribution facilities in Ontario, Calif., and Breinigsville, Pa. B. Braun expects it to take at least three years to get a new plant up and running.

"Seeing patients sent home and seeing clinicians have to use alternative techniques to treat patients because IV solutions are not available is just not acceptable," said Dr. Maria Angela Karpf, who oversees medical affairs as a corporate vice president for B. Braun.

Sterile injectables like epinephrine and saline, which are some of the most widely used drugs, have persistently been in low supply. These fluids are used to mix antibiotics, hydrate patients, treat septic shock and other applications. Pharmacists and clinicians at many organizations meet on a weekly, if not daily, basis to try to work around shortages, which have delayed surgeries and led to errors. Patients also forgo medication if prices surge when shortages occur.

Fewer manufacturers produce these drugs as they opt for higher-margin products. And those that still make IV fluids make many other products on the same line, so one production snag or natural disaster can disrupt the entire supply chain. Notably, more than half of last year's drug shortages were caused by an unknown reason, according to data compiled by the University of Utah Drug Information Service.

B. Braun and other sterile injectable manufacturers have run into production issues over the past several years.

In 2017, the U.S. Food and Drug Administration sent a warning letter to B. Braun regarding its Irvine facility. It cites leaky bags and contaminated products amid a range of repeated violations from 2013 through 2016.

The letter was not exclusive to B. Braun and included all three IV fluid suppliers about industrywide remediation, B. Braun said.

"B. Braun is committed to regulatory compliance and to proactively lead the way to alleviate U.S. IV fluid shortages in the future—supporting healthcare providers and patients across the nation," the company said in a statement.

This new investment is one way to shore up quality issues, said Erin Fox, a drug shortage expert who is the senior director of drug information and support services at University of Utah Health.

"I am hopeful that these new investments will lead to a stabilization of the market, but I'm also a little worried that the investor-owned companies will want an ROI and will stop making basic products," she said.

Civica Rx represents a group of hospitals, health systems and philanthropic organizations striving for a similar goal. The not-for-profit company, which has garnered the support of more than 800 hospitals, will first contract with existing generic-drug manufacturers to produce generic drugs vulnerable to shortage, and it eventually plans to produce them in-house.

"If we are going to rely on existing manufacturers, there aren't many out there," said Rebecca Stolarick, corporate vice president of regulatory affairs at B. Braun. "This is about sustainability and addressing what needs to be done so we don't run into the same types of shortages."

Other stakeholders are making similar moves. Group purchasing and consulting organization Premier, for instance, recently announced a new company called ProvideGx, which has partnered with Baxter International to bolster the supply of generic drugs, the first of which will be the blood pressure medication metoprolol.

"We need to work together with other stakeholders in order to make sure we have the appropriate business planning and continuities in place," Karpf said.

It seems like every day something new is in shortage, said Felicia Schaps, president of the Infusion Nurses Society who is also general manager of home infusion provider ContinuumRx in Northern Virginia.

After Hurricane Maria hit Puerto Rico in 2017 and cut off major IV fluid supplier Baxter, ContinuumRx had to stop accepting patients who needed intravenous hydration and switched existing patients to other delivery mechanisms if possible, Schaps said.

"It got pretty scary for a while," she said.

When supplies are scarce, ContinuumRx is a relatively low priority compared with hospitals and national home infusion providers that typically receive allocations first, Schaps said. Ideally, these new ventures will help, she said.

"We need to have facilities spread out over different parts of the country so our source isn't wiped out if one plant goes down," Schaps said.