For weeks, public health experts have been watching to see whether factory shutdowns and shipping problems in China caused by the coronavirus epidemic will cause drug shortages in the United States.
Late Thursday, the Food and Drug Administration issued a statement noting that one drug is now in short supply because of problems related to the coronavirus outbreak. But it refused to disclose the name of the drug and its manufacturer — as well as where the product or its ingredients were made — saying that it could not reveal “confidential commercial information.”
The agency’s vague announcement angered public health advocates and those who track drug shortages, who said the lack of information would only create more confusion as the virus has spread around the globe to at least 56 countries from the original epidemic in China.
The F.D.A. has long been criticized by public interest groups for refusing to reveal company information that could affect public safety. Federal law protects companies from having trade secrets and confidential proprietary information disclosed, which the agency has cited to withhold details, like naming countries where raw ingredients come from.
“They’re using it as a convenient excuse not to release this information,” said Dr. Michael Carome, director of Public Citizen’s Health Research Group, a consumer advocacy organization, which has previously sued the agency to disclose more information about companies.
“Full transparency on issues like this is important to maintain public trust, and any hints that the government is hiding important information will sow distrust,” he added.
In a statement Thursday night, Dr. Stephen M. Hahn, the commissioner of the F.D.A., said the unnamed drug is already on the F.D.A.’s shortage list and that “the shortage is due to an issue with manufacturing of an active pharmaceutical ingredient used in the drug.” He also said there were other alternatives that could be used by patients and that the agency was working with the manufacturer, as well as others, to address the shortage.
China is the dominant global supplier of the raw ingredients used in many common drugs, from antibiotics like penicillin to painkillers like ibuprofen and aspirin. Many Chinese factories closed their doors as a result of the coronavirus outbreak, with millions of citizens ordered to remain at home. While many plants have reopened, experts in the drug supply chain say some are operating at reduced capacity and that shipping has been interrupted.
Representative Anna Eshoo, Democrat of California, said in a telephone interview that the F.D.A. had told her office Friday that the drug in question was a generic and that the shortage was because of “the circumstances on the ground in China.” But she said the agency did not tell her the name of the drug. Ms. Eshoo has previously warned about Americans’ dependency on China for their drug supply, holding a hearing last fall on the topic.
“People count on being able to get their prescription drugs — they go to the drugstore counter and they expect the druggist to have what they need, and pay for it, and leave,” she said. “So what stands out to me is how many holes there are in this, how many unanswered questions there are.”
The F.D.A. has said it is closely monitoring about 20 products where the manufacturers rely solely on China for their finished products or active pharmaceutical ingredients. Dr. Hahn said Thursday that the drugs being monitored are considered “noncritical drugs.”
Hospitals have struggled for years with shortages of hundreds of critical drugs, many of them staples of medical care that have been on the market for decades. In 2017, Hurricane Maria damaged many pharmaceutical factories in Puerto Rico, closing them for weeks and leading to supply problems, including a shortage of saline bags made by Baxter. Problems with manufacturing quality have caused other shortages, including a global shortfall of valsartan, a widely used blood pressure drug.
Erin Fox, a drug shortage expert at the University of Utah, said, “When the F.D.A. tells the American public that there is a shortage without disclosing the specific drug, this only creates fear and panic, which is unacceptable in the current situation.”
The F.D.A. frequently cites companies’ proprietary reasons for why it does not disclose certain information, including the names of specific drugs when companies are cited for manufacturing problems, or details about clinical trials, Dr. Carome said. “Those are examples where I think it’s an overuse,” he said.
Ilisa Bernstein, who was a top compliance official at the F.D.A. until last fall and is now a senior vice president at the American Pharmacists Association, said the agency must maintain a balance. “Pharmacists want transparency, they want to be able to have the information that’s needed so they can better care for their patients,” she said. “But behind the scenes, I know the F.D.A. is working hard to figure out what the impact will be on the availability of that product.”
Representatives for several drugmakers have said they have several months’ supply of pharmaceutical ingredients, but some have acknowledged that if problems persist, they could encounter trouble. This week, Richard Saynor, the chief executive of Sandoz, the generic manufacturing arm of the drug giant Novartis, said in a LinkedIn post that “while we think we have solid levels of safety stock at my company, it is hard to predict how the situation will evolve further as the virus spreads to more and more countries.”
Mr. Saynor also said that the fears over supply shortages traced to China underscores the risks the industry faces when it is too reliant on a single region for its ingredients. “The real issue is not where producers are located, it is the extent to which they are all located in the same region. (Think oil and the Middle East),” he wrote, adding that Sandoz would keep prices stable for what he described as a basket of essential medicines that may help in treating the new coronavirus.
Sheila Kaplan contributed reporting.
