No drug manufacturers have reported that they anticipate shortages of particular drugs due to the novel coronavirus, according to the US Food and Drug Administration, but the agency and experts in the pharmaceutical industry are paying close attention to the potential challenges the virus might pose.
“FDA is keenly aware that the outbreak will likely affect the medical product supply chain, including potential disruptions to suppliers [and] shortages of critical medical products in the US,” FDA Commissioner Dr. Stephen Hahn told reporters Tuesday.
The US relies heavily on Chinese-made medical devices, drug ingredients and drugs for humans and animals, and, with heavy Chinese investment in the industry in recent years, its share of the global market has steadily grown.
As of 2018, China ranked second among countries that exported drugs and biologics to the United States, and first for medical devices, according to the FDA.
The FDA said Monday it has been in touch with 180 drug manufacturers to remind them of their regulatory obligation to notify the FDA if they do anticipate any disruption in drugs supplies. The agency asked companies to evaluate their supply chain in light of the coronavirus outbreak and what potential challenge the virus may pose to the global drug supply, the agency said.
The FDA said it has identified about 20 drugs that either solely source their active pharmaceutical ingredients or produce finished drug products from or in China.
“We have been in contact with those firms to understand if they face any drug shortage risks due to the outbreak. None of these firms has reported any shortage to date,” FDA spokesperson Stephanie Caccomo said Monday in a statement. “We will continue to remain in contact with the manufacturers so that we can best help mitigate any potential issues in the future.”
Most active pharmaceutical ingredients — the drugs that are formulated into capsules, tablets and injections — are not manufactured in the United States.
As of August 2019, 13% of active pharmaceutical ingredients for the US market were made in China, Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said in testimony before a House Energy and Commerce subcommittee in October. The number of firms making those ingredients in China more than doubled between 2010 and 2019. In August 2019, the EU made 26% of these ingredients for the US market and India made 18%.
China also manufactures many medical goods, such as the protective masks, respirators and gowns that health care workers use.
US Health and Human Services Secretary Alex Azar said Tuesday that some of the $2.5 billion the White House requested from Congress would be used to buy personal protective equipment from the national stockpile. Azar told a Senate Appropriations subcommittee that there are 30 million N95 respirators in the Strategic National Stockpile, and the US would need about 10 times that number for health care workers.
Outbreak disrupts FDA inspections
With the US State Department’s travel advisory for China, the coronavirus outbreak has disrupted FDA inspections of drug and medical supply firms in China. Roughly 100 scheduled inspections in China in February and March have been put on hold, Hahn said.
Inspections are just one tool the FDA uses to make sure products are safe, and the lack of inspections is “not hindering our efforts to monitor medical products and food safety,” officials said.
In response to the outbreak, the FDA said it will also use, where appropriate, the agency’s authority to request records from firms “in advance or in lieu of” drug surveillance inspections in China. Paper records will help prioritize which inspections should happen first during what could become a backlog in on-the-ground inspections, depending on how long the travel restrictions continue, the agency said Monday.
The FDA reiterated that there is no evidence that the virus can be transmitted through imported goods, but added that this is a “dynamic” situation and the agency will continue to assess it and update guidance as needed.
A system ‘vulnerable to interruption’
The industry association that represents pharmaceutical companies, PhRMA, said the coronavirus remains on their radar.
“PhRMA and our member companies are closely monitoring the coronavirus and the situation in China,” said Holly Campbell, PhRMA deputy vice president of public affairs. “As the situation evolves, companies are continuously monitoring the situation and are working proactively to prevent and mitigate potential shortages through close coordination with the FDA and other global stakeholders.”
Medical devices that are manufactured in China “have their own set of issues,” according to Steven Shill, the partner and national leader of the BDO Center for Healthcare Excellence & Innovation. “(Medical devices) may be even more difficult to replicate than pharmaceutical ingredients because of the technical nature of what they do and how (the devices) are manufactured. Executives from group purchasing organizations have been elevating their focus on stocking and finding alternative suppliers if need be, he said. “But we want to make sure organizations don’t hoard.”
Experts say the market for generic drugs may be the one to watch because it has tight margins and is key to American health care. Ninety percent of prescriptions dispensed in the United States are generics and the US buys a wide range of Chinese-made generic drugs, including antibiotics, birth control pills, cancer treatments, medicine to fight HIV/AIDS and diabetes, and drugs for Parkinson’s disease, among others.
Concerns about the US dependence on medical products from China have been bubbling since long before the coronavirus. These concerns were discussed at length at a hearing before the US China Economic and Security Review Commission in July.
Rosemary Gibson, a senior adviser with the Hastings Center and the author of “China RX: Exposing the Risks of America’s Dependence on China for Medicine,” cautioned against American reliance on any one country for medical products.
“The centralization of the global supply chain of medicines in a single country,” Gibson testified in July, “makes it vulnerable to interruption, whether by mistake or design.”