Exclusive–Alfredo Ortiz & C.L. Gray: Coronavirus Provides Impetus to Bring Generic Drug Manufacturing Home

A chemist is seen working in a lab where medicines are being produced at a Cipla manufactu
AP Photo/Rafiq Maqbool

Last week, White House trade adviser Peter Navarro revealed the Trump administration is working “full bore” to craft an executive order to increase the domestic production of medicines and medical supplies. A reshoring of pharmaceutical production is needed now to respond to the coronavirus more than ever. The U.S. is currently dependent on China, the nation that unleashed this devastating pandemic, for the vast majority of medications we now use.

China controls the raw material and chemicals needed to make thousands of generic drugs. In a March testimony before the Senate Small Business Committee hearing, Rosemary Gibson, a national expert on the healthcare supply chain and author of the book, China Rx, testified that China has a chokehold on 90 percent of the materials used in medicines to care for people seriously ill with coronavirus.

U.S. dependence on China threatens the country’s coronavirus response. From sedatives such as propofol given to people on ventilators, to antibiotics needed for secondary infections and medicines to raise dangerously low blood pressure, China controls most of the chemicals required to make them. This utter dependence on China fuels the U.S. crisis of drug shortages, which are especially consequential during a pandemic.

The FDA announced its official first coronavirus-related drug shortage in February. Critical antibiotics to treat pneumonia are already being rationed in hospitals across the nation. At the Senate Small Business Committee hearing, a Johns Hopkins University professor said that its hospital has a shortage of 200 to 300 drugs, far more than the 98 officially reported by the FDA. 

At least 75 countries have banned exports of critical medicines and supplies such as masks and other protective gear to ensure enough for their own people. Allies including the U.K. and India banned exports of essential drugs. We can no longer rely on others to make our medicines.

In March, China threatened Americans in its state-run media: “If China announces that its drugs are for domestic use and bans exports, the United States will fall into the hell of a new coronavirus epidemic.”

China’s generic manufacturing dominance threatens not only drug supply shortages but also drug integrity. Millions of Americans had their blood pressure medicines recalled beginning in 2018 because they contained carcinogens. A Chinese company supplied the key ingredient for many of these products; these key ingredients contained more than 200 times the acceptable limit of a chemical found in rocket fuel. More than 31,000 active-duty military personnel, veterans, and their family members were affected. 

In 2008, 246 Americans died and thousands more were injured when a widely used blood thinner made in China, heparin, was contaminated. Detecting faulty drugs is difficult-to-impossible. The last thing critically ill patients and their doctors should have to worry about is whether their medications being used are contaminated. 

The White House Office of Trade and Manufacturing Policy is preparing rules to direct HHS, the VA, and the Department of Defense to buy U.S. manufactured medicines and supplies for their government contracts. This is the first and most crucial step in securing safe and reliable medication for the American public. 

At the same time, lawmakers must immediately work to bring the supply chain back to American shores. They can achieve this goal by deeming medicines a strategic asset, requiring federal government departments and agencies to buy medicines made in the U.S., and supporting capital investment and other incentives to restart drug manufacturing. These initiatives can be included as part of the upcoming Phase 4 coronavirus stimulus legislation. They would boost the economy, create jobs, and revitalize communities around the country.

Entrepreneurs with expertise in pharmaceutical manufacturing are ready to step in to manufacture critical generic drugs in the U.S. By using advanced manufacturing technology, the cost of production is lower and the quality of medicines can be assured with real-time quality control.  

Generic medicines such as antibiotics are vital to Americans’ health and wellbeing in the best of times. Even more during a pandemic. The coronavirus reinforces the importance of domestic production capacity and provides the impetus for legislation to bring critical manufacturing home and ensure our health security. 

This is not a partisan issue and patient care is not political. We must be able to manufacture our own medications to protect Americans during this pandemic and in its aftermath. The White House’s executive order will make help make this vision a reality.

Alfredo Ortiz is the president and CEO of the Job Creators Network. C.L. Gray is the president and founder of Physicians for Reform and a physician in western North Carolina.


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