FDA's Hahn: No sign China has affected U.S. drug supply during coronavirus pandemic

talks resume in china on trade
Despite U.S. tensions with China, the supply of raw ingredients for American drugs is safe so far, FDA commissioner Stephen Hahn said. (Getty)

With pharmaceutical supply chains under immense pressure due to the novel coronavirus, China's role as a global ingredient producer has come under scrutiny. Despite fears the East Asian nation could shut off the tap for U.S. drugs, the FDA said it hasn't yet noticed major signs for concern.

The FDA hasn't seen a shortage of active pharmaceutical ingredients (APIs) sourced from China due to the ongoing novel coronavirus outbreak but is "closely monitoring the situation," FDA Commissioner Stephen Hahn told Fox News on Sunday.

"We don’t have any evidence that there’s a drug in short supply because of anyone blocking the active pharmaceutical ingredients coming to us (from China)," Hahn said.

Sponsored by Lubrizol Life Science

[Webinar] Cannabinoid Formulation - from Farm to Pharma

Wednesday, June 24, 2020 | 12pm ET / 9am PT

A handful of cannabinoid-based pharmaceutical products are on the market today, and an ever-growing number are in the global development pipeline. This webinar will explore key considerations in developing cannabinoid-based pharmaceutical products, including an overview of global pharmaceutical cannabinoid usage today, common challenges formulating with CBD and other cannabinoids, and more.

China's role as a major supplier of global APIs for generic and branded drugs has come into focus as the novel coronavirus and COVID-19 have increasingly strained the pharmaceutical supply chain in recent weeks.

Hahn highlighted reported spot shortages of certain drugs due to increased demand but said China's API tap is still running, despite escalating rhetoric between the Chinese and U.S. governments. Hahn highlighted the Trump administration's push to develop "advanced" manufacturing stateside to help drive greater redundancy in the supply chain.

RELATED: Gilead turbocharges production of COVID-19 hopeful remdesivir

Last week, the FDA reported shortages of hydroxychloroquine and chloroquine, antimalarial meds that have been targeted by President Donald Trump and others as front-runners for a possible COVID-19 therapeutic.

Despite a "significant surge in demand," the FDA said manufacturers were working to ramp up production of the drugs to supply ongoing clinical trials as well as fill prescriptions for existing patients. The FDA's updated drug shortages list as of Monday listed 148 products.

Other approved drugs and investigational candidates have neared shortages as the push for a COVID-19 therapeutics continues.

Last month, Gilead Sciences announced it would halt emergency access to antiviral candidate remdesivir after "overwhelming demand" tied to positive anecdotal evidence in Chinese clinical trials and the launch of a series of global studies.

On Sunday, Gilead CEO Daniel O'Day said the drugmaker had accelerated production of remdesivir to help meet that demand, cutting the drug's manufacturing timeline by six months. Gilead pledged to donate 1.5 million doses of remdesivir––approximately 140,000 treatment courses––through its emergency and compassionate use programs and to ongoing clinical trials.

Suggested Articles

WuXi AppTec has appointed Celgene CAR-T program veteran David Chang to lead its cell and gene therapy CDMO, WuXi Advanced Therapies.

Maryland-based Emergent BioSolutions has won a $628 million contract with BARDA to manufacture targeted COVID-19 vaccine hopefuls.

About 76% remdesivir patients had at least one point of clinical improvement on a 7-point scale at day 11, versus 66% of patients on standard care.