Against the backdrop of the global spread of COVID-19, India announced restrictions Tuesday on the export of 26 active pharmaceutical ingredients (APIs) and formulations of those ingredients.
The order, put out by India’s Directorate General of Foreign Trade, went into effect immediately and will remain in place until further notice. The list includes progesterone; several common antibiotics; acyclovir, an antiviral; paracetamol, or acetaminophen, which is used in over-the-counter and prescription drugs that treat fever and pain; and vitamins B1, 6 and 12.
The listed APIs and drugs represent about 10% of India’s export capacity, FDA Commissioner Stephen Hahn told the Senate Health, Education, Labor and Pensions (HELP) Committee during a hearing Tuesday, March 3, on how the U.S. is responding to COVID-19.
What India’s action will mean for the U.S. drug supply remains to be seen. Hahn said the agency is assessing the list to determine what impact the export restrictions will have on the U.S., especially as Americans face the spread of the novel coronavirus.
For some lawmakers, India’s order highlighted all the more the need to build redundancy into the U.S. drug and supply chain and to have more medical products and APIs produced at home. Ever since the new coronavirus emerged in China, the health of the U.S. supply chain has been a concern.
To get ahead of any shortages, the FDA has kept in touch with more than 180 drug companies in China and the manufacturers of 63 devices that are considered essential. While there have been no shortages of those devices so far, Hahn said some of the manufacturers have reported workforce disruptions in China due to COVID-19. A disruption in the manufacture of a chemical used to produce an API has resulted in the shortage of one drug so far.
Sen. Susan Collins (R-Maine) noted that the FDA has said in the past that about 28% of the APIs used to make the drugs used in the U.S. are manufactured domestically; 13% are made in China. While drug companies must alert the FDA to potential shortages, no such requirement is in place for API makers. A bill she introduced in October 2019, the Mitigating Emergency Drug Shortages (MEDS) Act, would require manufacturers to report to the FDA the exact location of manufacturing for critical drugs, the exact source of all their raw materials, and their redundancy and contingency plans to ensure a stable supply. “Would that help?” she asked Hahn.
This has been an ongoing problem even before COVID-19 emerged, Hahn responded. He also recommended that Congress consider similar reporting requirements for device makers, which currently don’t even have to respond to agency queries about supply chain problems. The bipartisan Medical Supply Chain Security Act, introduced in the House Monday, would give the FDA the authority to analyze sourcing locations of all medical products, including devices, and help alleviate shortages more quickly.
“Due to our dependence on foreign manufacturing, we need to better understand the threat that supply chain shortages for life-saving medical devices have on patients in America, and we must ensure our government is able to prepare accordingly,” Rep. Mark Pocan (D-Wis.) said in introducing the bill.
Too much dependence?
Regardless of stronger reporting mandates, there’s still the issue of having the manufacturing of essential products based in other countries, especially during times of a global health crisis. This isn’t a new concern. It’s cropped up every time the nation has faced a potential public health emergency over the past few decades.
Sen. Tammy Baldwin (D-Wis.) recalled a shortage of flu vaccines several years ago when a manufacturer in the U.K. was shut down. A few years later, when health experts were warning of a potential serious flu strain, she was told that there was no domestic manufacturing capacity for the flu vaccine. While the U.S. could order the vaccines from overseas manufacturers, it faced the risk of having the countries where the vaccine was manufactured commandeer the supplies for their own needs. “I hope that we ensure we don’t make those mistakes again,” Baldwin said, adding that “domestic capacity is very crucial.”
When it comes to vaccines, those mistakes have not been corrected. Assistant Secretary for Preparedness and Response (ASPR) Robert Kadlec told the committee that the only domestic capacity the U.S. has is for egg-produced vaccines. That wouldn’t be relevant to the COVID-19 vaccine candidates ASPR’s Biomedical Advanced Research and Development Authority is pursuing, and it could add more than a six-month wait to produce a coronavirus vaccine on the scale it would be needed.
Anthony Fauci, director of the NIH’s National Institute of Allergy and Infectious Diseases, agreed. While a vaccine candidate could be ready to go within 18 months, he said it could take longer than that to produce it in large enough quantities if there are no production facilities. “The federal government is not going to be able to make hundreds of millions of doses. It’s going to have to be in partnership with the private sector,” he said.
Sen. Mitt Romney (R-Utah) raised another concern about the nation’s preparedness for a major pandemic, quizzing Kadlec about the adequacy of the supply of personal protection equipment, including respirators and masks, included in the national stockpile.
It would depend on the emergency, Kadlec replied, but currently, the stockpile has about 10% of the personal protection equipment medical staff would need in a substantial pandemic. And it contains no masks for the general public.
In concluding the hearing, HELP Chair Lamar Alexander (R-Tenn.) said, “When we’re not in the middle of [COVID-19], I want to have some discussion about the extent to which we rely on other countries for our medical supplies and medicines and what we should be doing about it that we’re not.”
The committee needs to look at that reliance, as well as sole-sourced medical products or components, he said, adding that redundancy is especially needed for life-saving products. He also suggested having the National Academies study the issue.