Generic drugmakers have pledged to work with the FDA to formalize the process for manufacturers and other members of the supply chain to report drug shortages to the FDA, "as many now do voluntarily," says a statement from the Generic Pharmaceutical Association (GPhA). Ralph Neas, CEO, adds that "dramatically reducing drug shortages is not out of reach."
Several drugmakers, including Teva ($TEVA) and Hospira ($HSP), deferred to GPhA when asked for comment regarding Monday's executive order and the U.S. Department of Health and Human Services report on the economic causes of shortages.
At Bedford Labs, spokesman Jason Kurtz expressed disagreement with the HHS finding of the effect of pricing on drug shortages.* He writes in an email, "[w]e do not consider short-term changes in price to be a significant contributor to shortages in general." Rather, causes include "unplanned increases in demand due to shortages caused by the discontinuation or delay of certain drugs produced by other manufacturers, inability to obtain key ingredients, and the need to shut down manufacturing lines or entire facilities due to necessary maintenance, facility upgrades or capital improvement projects."
Kurtz explains that the complexities of sterile injectables manufacturing--especially for toxic chemotherapy drugs--can drive shortages. "The aseptic process is multi-variable, extremely complex and therefore susceptible to manufacturing and quality-related disruptions," he writes. Bedford Labs is prioritizing and expediting production of its sole source, medically necessary products.
"We are also working hard to increase manufacturing capacity," he writes. The company is in the final stages of building a 240,000-square-foot cytotoxic/genotoxic facility for the manufacture of chemotherapy drugs. The facility, plus "other continuous improvement initiatives" will help Bedford Labs put additional product into the market.
At Baxter ($BAX), spokesperson Deborah Spak says via email that the company's offerings provide options for meeting supply needs via drugs that are similar to those in short supply but available in "slightly different formats," such as a premix intravenous formulation versus an injectable.
In addition, writes Spak, Baxter has "accelerated production to meet the increased demand arising from competitor shortages" of some parenteral nutrition drugs. The manufacturer "increased production across five product lines by nearly 40% to fill the void typically met by other suppliers."
APP Pharmaceuticals ($APPX) has also stepped up manufacturing. It "significantly increased production" at its U.S. manufacturing facilities to aid in resolving the shortage of cancer treatment cytarabine. In addition, it worked with parent Fresenius Kabi Pharmaceuticals ($APCVZ), to begin production at Fresenius' facilities in Europe to help resolve the propofol shortage.
Hospira said in a statement that it supports legislation for mandatory manufacturer reporting and penalties for failure to report, and says it has always given the FDA advance warning. The Chicago-area manufacturer is addressing shortages, according to the statement, by building additional capacity, increasing inventory and making manufacturing improvements. "Hospira is focusing on its most critical life-saving drugs and prioritizing their manufacture," the statement says.
- here's the GPhA release
- see the Hospira release
* Editor's Note: The story originally stated Mr. Kurtz is with Boehringer Ingelheim, Bedford's parent company. The story has been changed to indicated he is with Bedford. We apologize for any confusion.