B. Braun Medical, which has been a key figure in the nation’s shortage of IV fluids, says it is committed to helping fix the problem. It will invest $1 billion in its U.S. manufacturing and supply chain, including building a new manufacturing facility in Florida.
The German infusion therapy company, which has dubbed its effort “Solutions for Life,” will expand and enhance existing plants in Irvine, California, and Allentown, Pennsylvania, along with distribution facilities there. A new distribution facility will also be built along with the new manufacturing plant in Daytona, Florida.
“Solutions for Life is our commitment to helping ensure consistent supply of vital saline solutions and other IV fluids that hospitals and health systems depend on to treat patients,” B. Braun CEO Caroll Neubauer said in a statement.
The shortage and rapidly rising prices of the most ubiquitous of hospital supplies came to the forefront in the fall of 2015 when senators from both parties held hearings and called on the Federal Trade Commission to investigate why shortages of saline persisted even as prices were rising. The senators pointed out that Baxter, B. Braun and Hospira—now owned by Pfizer—were the three largest producers of saline for the U.S. market.
The drugmakers denied any collusion at the time.They insisted they were increasing production to try to meet demand, but the supply situation deteriorated further amid a bad flu season in 2017 along with hurricanes that year that interrupted production of key Baxter facilities in Puerto Rico. Hospitals scrambled to find supplies and had to ration the once-ubiquitous product the healthcare system used millions of times a day.
Braun says that discussions with healthcare providers and policymakers following Hurricane Maria in 2017 “cemented the company’s motivation” to advance planned investments to meet future IV fluid supply needs for the market.
But along with its espoused altruism to help fix the problem, B. Braun has had to face regulator questions about its own failings. In 2017, the FDA issued a warning letter to the company’s plant in Irvine citing a long list of problems the FDA said had persisted for years despite its insistence that the company fix them. They included leaking and moldy IV bags and unresolved customer complaints.
The FDA told the company the repeated violations demonstrated a failure of its “executive management to exercise proper oversight and control over the manufacture of drugs.” It said the Melsungen, Germany-based company should do a comprehensive assessment of its “global manufacturing operations” and suggested it get an outside consultant to help.
May 15, 2019