Lack of FDA Transparency Adds to Coronavirus Panic

The Food and Drug Administration has now admitted 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 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 proprietary information disclosed, which the agency has used an excuse 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.

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.”

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.

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.”