On this week’s episode of the podcast, Bob reprises his interview with Janet Woodcock, the director of the Center for Drug Evaluation and Research (CDER) at the FDA, about the hurdles to reshoring drug manufacturing to the U.S. Currently, roughly 80 percent of pharmaceutical ingredients are produced in China and India, posing safety, supply, and national security threats to Americans.
The Covid-19 pandemic has demonstrated once again the vulnerability of the U.S. drug supply chain. Nearly all antibiotics, which are needed to treat the secondary infections that Covid can cause, are produced abroad. As foreign countries implement export controls to maintain drug supplies for their domestic populations, the U.S. could face increased shortages.
In 2008, at least 81 Americans were killed when the common blood-thinning medication Heparin was contaminated in China. This outcome was just one of many recent examples where Americans have been seriously hurt by shoddy foreign supply.
Ms. Woodcock highlights how reshoring barriers include high U.S. real estate, environmental, and labor costs, which are far cheaper abroad. She has been attempting to bring drug manufacturing back to the U.S. for the last 25 years.
Ms. Woodcock explains how we don’t need to bring back all drug manufacturing. We just must ensure we have the three “Rs”: redundancy, resiliency, and robustness. In other words, we need to ensure there are many points of production, so capacity can be increased when there’s a supply or a demand shock, such as a natural disaster or a pandemic.
She argues that U.S. advanced manufacturing can make stateside drug manufacturing profitable. U.S. technology can make drug-making more continuous — like an assembly line — reducing inventory and labor costs. Reshoring drug manufacturing is one of the few genuine bipartisan efforts on Capitol Hill.
Terry highlighted the dangers of the foreign drug supply chain in an op-ed last year:
The inability to guarantee the safety of drug imports is why the past four FDA administrators, serving under both Republican and Democratic administrations, have opposed drug importation. “There is no effective way,” says Gottlieb, “to ensure drugs coming from Canada really are coming from Canada, rather than being routed from, say, a counterfeit factory in China.”
With the World Health Organization now estimating that one in 10 drugs from less developed countries are counterfeit, Americans seeking to lower their drug costs must recognize the risks of import shortcuts.