The intricacies of the supply chains for individual medicines—which companies keep under wraps for competitive reasons—remain hidden from the public. While the FDA requires manufacturers to report when there is a shortage of a specific product, companies that make the raw materials aren’t subject to such demands. Nor must they disclose the size, or timing, of shipments being made to the U.S., limiting the ability of hospitals and other providers to plan for potential supply disruptions. The FDA says it has no way to track API volume out of China.
“We technically have no idea what is actually manufactured in China,” said Soumi Saha, senior director of advocacy at Premier, one of the largest group-purchasing organizations in the U.S. contracting for drugs and other supplies for hospitals. “We’re missing that upstream visibility.”