Opinion: How we can avoid the next health care supply shortage — essential generic medicines

Phlow Corp. co-founders, VCU dean discuss prescription drug shortage solutions

Published May 26, 2020 by B. Frank Gupton / Barbara D. Boyan / Eric S. Edwards

Amid the COVID-19 crisis, America is witnessing something many of us once thought impossible: critical shortages of health care supplies. Doctors are devising ways to make one ventilator serve two patients, and citizens are sewing protective masks for donation to local hospitals. While this kind of American resourcefulness is uplifting, it is a situation that is completely precarious and avoidable.

Despite the fact that the U.S. is the largest consumer of pharmaceuticals in the world, another, possibly more dramatic, health care shortage is looming: essential generic medications. Many of these drugs were already in short supply prior to the pandemic, and the problem is worsening by the week. But here’s the good news: It’s not too late for America to head off this crisis.

Of the more than 4 billion prescription medicines dispensed in the United States last year, only 20% were produced in America. Over the past few decades, America has lost a key domestic manufacturing industrial base, essential generic medicine ingredient manufacturing. We import the bulk of our most important generic medicine ingredients from foreign countries, especially China and India, who also have health care systems that have been overtaxed by the COVID-19 pandemic. This is an unsustainable and dangerous supply chain vulnerability.

Are we prepared for a scenario in which the vast majority of our essential generic medicines are unavailable because overseas manufacturers cannot — or will not — supply them? Now is the time to come together and bring back generic pharmaceutical manufacturing back to American soil.

We have abundant technology, knowledge and infrastructure to accomplish this here at home. What would it take to mobilize our forces and create a robust, sustainable supply chain of essential generic medications in our country? We need visionary public-private partnerships.

Engineering researchers in universities including MIT, Rutgers and Virginia Commonwealth University are creating advanced manufacturing methods which dramatically reduce the financial and environmental cost of producing pharmaceuticals. These include advances in continuous flow processing, which produces active pharmaceutical ingredients (APIs) in an uninterrupted stream — instead of batch-by-batch processes, as they are commonly produced today. Continuous flow processing is much more cost effective than batch processing and generates less waste. More importantly, APIs produced in this way are more consistent and tend to be of higher quality.

Much of the research to create these methods is currently funded by nonprofit organization grants to universities seeking to make life-saving medications more accessible to the developing world. If we are to re-secure this critical industrial base, government, private corporations and nonprofits must act quickly to tap into these advanced pharmaceutical manufacturing breakthroughs for the benefit of the U.S. population as well.

Coming together to manufacture critical generic medicines and their ingredients in the U.S. is essential to ensuring the health care of Americans and is a matter of national public health security.

This is urgently needed for the treatment of COVID-19. Essential generic medicines include sedatives and other drugs to help patients who require ventilators, medicines to support blood pressure control, and antibiotics to help fight infections common in these patients. It is equally necessary for the post-pandemic world. A commitment to domestic manufacturing of essential generic medicines will bring significant benefit to society. It will also boost the U.S. economy by providing a highly skilled workforce for the future. In other words, it will save — and improve the quality of — millions of lives.

We stand in a transformative moment in American history and have the advantage of awareness. The actions we take today will have a significant impact on the future. In the midst of this devastating COVID-19 there can be a silver lining. Let us seize this rare opportunity by bringing the public and private sectors together to build a safer, healthier and more hopeful American future for generations to come. We can do it, here and now.

Barbara D. Boyan is the Alice T. and William H. Goodwin Jr. Dean of Virginia Commonwealth University’s College of Engineering. Dr. Eric S. Edwards is co-founder, president and CEO of pharmaceutical startup Phlow Corp., as well as the chair of VCU’s School of Pharmacy Graduate Advisory Board. B. Frank Gupton, also a co-founder of Phlow Corp., is chair of the VCU College of Engineering’s Department of Chemical and Life Science Engineering, as well as director of the Medicines for All Institute.