For the first time, supplies of a drug have run short in the U.S. as a result of problems tied to the spread of the new coronavirus, the Food and Drug Administration reported Thursday evening after a manufacturer alerted the agency.The medicine, which the FDA did not name, had recently been added to the regulator’s drug shortage list; two possibilities are a generic beta blocker and an off-brand inflammatory treatment, both of which were recently posted.Other alternatives to the drug in shortage exist and the FDA said it is working to resolve the situation. But the update is a worrying sign the viral outbreak’s impact on manufacturing in China and supply chains flowing from it could begin to impact the availability of medicines in the U.S., which relies on foreign countries for much of its drug ingredient supply.
Virus containment measures imposed by the Chinese government have resulted in shutdowns or partial closures at manufacturing plants in Wuhan, the province in which the new coronavirus emerged, as well as other nearby areas.
For the drug industry, sustained reductions in Chinese production could quickly become a problem. The country accounts for a good deal of the active pharmaceutical ingredients contained in many common drugs, as well as the starting chemicals used to produced those ingredients elsewhere.
A report from the FDA last year calculated that 14% of plants making API for the U.S. market were located in China, the third highest proportion after India and the European Union.
Currently, the agency is focused on monitoring supplies of 20 drug products that are solely sourced — either in API or finished form — from China. As of Thursday morning, none of those drugs were in shortage, according to FDA Commissioner Stephen Hahn.
But the shortage reported Thursday evening for an unnamed medicine could suggest a hastening impact from the epidemic.
“The situation seems to have evolved quickly; the agency seemed pretty confident in statements a week ago that there was little near term risk,” wrote former FDA head Scott Gottlieb on Twitter.
“This may underscore the complexity of the supply chain and the challenge of knowing where all downstream ingredients are sourced,” he added.
The FDA would not disclose to BioPharma Dive the specific drug in shortage, citing “confidential commercial information.”
However, the agency’s statement indicated the drug was recently added to its drug shortage database. Some 10 shortages are listed as newly added, of which six are marked as due to manufacturer discontinuations and a seventh is now resolved.
Allergan’s antibiotic Avycaz is newly in shortage as the drugmaker “awaits regulatory approval on a new third-party manufacturer,” a company spokesperson confirmed.
Of the two other drugs, one, a beta-blocker called pindolol made by Mylan and Sun Pharmaceutical, is listed as in limited supply due to a shortage of active ingredient. Mylan didn’t respond to questions from BioPharma Dive by publication.
Generic drugs could be particularly at risk. Four industry executives polled by analysts at Bernstein, an investment bank, estimated the supply chain currently has six to nine month’s supply of chemical starting material and active ingredients.
Should the outbreak — and aggressive public health responses to it — continue for several more months, spot shortages could begin to crop up more frequently, the executives said.
Ten major producers of branded drugs all said the outbreak was not currently resulting in shortages of their products. Several, however, noted that could change if production impacts are sustained for several more months.
