COVID-19 has emphasized an urgent need to modernize how we manufacture medicines. Americans would benefit most from improving how we produce medicines, making them cheaper, more effective and more accessible.
This wouldn’t be the first time a pandemic threat inspired innovation. The threat of the H5N1 pandemic spurred modernization of vaccine development from a 70-year old process of growing viruses in chicken eggs (egg-based vaccines) to growing them in cells (cell-based vaccines). Now, the SARS CoV-2 pandemic has demonstrated the need to move to “advanced manufacturing” for drugs, devices, as well as biologics.
The director of the Food and Drug Administration’s Center for Drug Evaluation and Research, Dr. Janet Woodcock, has underscored the value of advanced manufacturing of medicines, citing quality, flexibility and the stable supply-chain benefits of conducting advanced manufacturing in the United States. Recognizing this, Rep. Brad Wenstrup (R-Ohio), a member of the powerful House Ways and Means Committee, recently introduced the Advance Medical Manufacturing Equipment Credit (H.R. 7767) to incentivize investments in advanced medical manufacturing to assure U.S. leadership in this emerging field.
So, what does advanced medical manufacturing achieve? A new portfolio of therapies that includes the integration of complex biologic molecules like antibodies, the utilization of cell therapies and even nanotechnologies for unique drug formulations.
For many years, treating cancer and many other chronic diseases meant taking a chemical pill produced using standard manufacturing technologies. The process was like a traditional assembly line, such as those used to make everything from a Chevrolet to a microchip. Research and development has moved medicine in a new direction, though standard pill-production facilities will remain with us for some time (just as we still use egg-based vaccines).
Consider Chimeric Antigen Receptor Therapy or CAR-T, which has revolutionized cancer medicines over the last few years. CAR-T is a process that begins by removing white blood cells from a patient and then isolating the T-cells, which fight diseases. These T-cells are then altered to target and attack the surface of cancer cells in the patient. Once the modified T-Cells are reinjected into the patient, they become anti-cancer warriors, seeking out and destroying the unwanted pathogens without harming healthy cells.
The pandemic has shined a bright light on why we need such lifesaving medical interventions produced here in the United States. An Advanced Medical Manufacturing Equipment Credit would incentivize and spur needed development and utilization, helping our manufacturing capabilities to scale up proportionate to the complexity of modern medicines.
In the future, an increasing number of therapies for cancer, other chronic diseases, and even regenerative medicine to help repair damaged organs will require these advanced manufacturing processes. It’s an open question as to who will lead the world in the production of these new cutting-edge therapies, but creating new cutting-edge therapies will create a host of benefits.
First, it will benefit patients, with faster and cheaper access to treatment thanks to production of these medicines in the U.S. This means better health quality and outcomes for Americans. Second, it will mean new American jobs and tax revenues, as America will not only create new cures, but will also answer a demand that spans the globe. Third, it will guarantee continued technological leadership and continue the cascade of innovation leading to better patient care.
The world will compete for leadership, but only American leadership can guarantee access and expansion. American policymakers must recognize this reality. If we don’t step up and lead, others will, and may use their own leadership to achieve dominance and ultimately control over the next generation of medicines. China, other parts of Asia and Europe all aspire for world leadership in this critical field that will impact both the health of patients and economies.
With the future of medicine upon us, America cannot afford to lose this race. Congress should step up to the challenge and enact legislation like the Advanced Medical Manufacturing Credit to help win this competition.
Andrew C. von Eschenbach, M.D., is a former commissioner of the Food and Drug Administration and director of the National Cancer Institute.
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