By Peter J. Pitts
President Trump is considering a “Buy American” executive order requiring government agencies to purchase medicines and medical supplies domestically.
The goal is two-fold. First, the administration hopes to stimulate the economy and boost domestic manufacturers. Second, it wants to reduce our reliance on countries like China and India, which currently manufacture many of the raw pharmaceutical ingredients and even the finished medicines that Americans take every day.
The President’s order, while well-intentioned, is poorly considered. As conceived, it could actually impede efforts to bring new coronavirus treatments to patients. In order to defeat COVID-19, we need help from our global partners who have the expertise to deliver key ingredients. Now is not the time to upend long-established and robustly regulated supply chains.
Most medicines have two types of ingredients: active pharmaceutical ingredients (API) and the ingredients that help deliver the active component to somebody’s system (the “excipients”). Manufacturers source raw materials — usually chemicals — from all over the world, and bring them to a central location to synthesize both elements.
Today, most API manufacturing takes place overseas. According to the FDA, just 28 percent of facilities that make APIs for the U.S. market are located domestically. The remaining 72 percent are international.
In order to sell even one single pill in the United States, international facilities are required to comply with FDA regulations that ensure both quality and safety. The FDA routinely inspects foreign facilities that ship to the United States. It is the FDA’s job to assure that the compounds coming from China and elsewhere meet the same exacting standards of those products produced inside our own borders.
Trying to reorder these supply chains via executive diktat would be a disaster. Waiting for companies to get new production lines up and running in the United States would certainly lead to drug shortages. Once such an order hit, manufacturers would stop producing APIs overseas. And, while they race to build facilities and hire workers that can actually do the job, no new drugs would get produced. At a time when hospitals need all the supplies they can get, any delays would be catastrophic to the public health.
It’s a fantasy to think that a manufacturer could expand or build a new facility in a matter of weeks. And then there’s the issue of professional staffing. Pharmaceutical companies can’t just hire anyone off the street to oversee the safety and efficacy of APIs and excipient products. These jobs require intense training in, among other things, chemistry and FDA-required Good Manufacturing Processes. Sadly, American institutions don’t graduate nearly enough new chemists, pharmacologists and engineers to meet such a sudden spike in demand.
But let’s imagine that manufacturers could, magically, build new facilities overnight. They’d still face incredible cost challenges. Experts say making APIs in America can cost five times as much as it does in China or India.
Without keeping supply chains intact, it’ll be impossible to quickly mass-produce a coronavirus vaccine. For better or worse, we need to rely on other countries to bring us the FDA-inspected and approved materials we need. Let’s hope the administration reconsiders its ill-planned executive order.
Peter J. Pitts, a former FDA associate commissioner, is president of the Center for Medicine in the Public Interest.