The Case for Bringing Drug Manufacturing Back to America

This year has turned much of the world on its side as countries, communities, and companies reorient themselves to a post-COVID-19 existence. From work-from-home initiatives to new travel restrictions, the ways we work, the ways we move, and the ways we interact with each other may never look the same. Within this mosaic of change are new areas of opportunity for many industries. Where challenges and difficulties first appeared, new solutions are now emerging.

Nowhere is this potential innovation and improvement more evident – nor more necessary – than in the field of drug manufacturing.  The COVID-19 pandemic laid bare fractures in the pharmaceutical production industry and while the fixes will not be easy, they most certainly are viable and urgently required. In this post, we will examine the most critical issues in the drug manufacturing sector as well as the substantive benefits available to manufacturers and patients alike by bringing drug production back to the United States.

How We Got Here

In the 1970s and 1980s, tax incentives and benefits led to the relocation of significant drug manufacturing from the United States to places like Puerto Rico and Europe. As the twentieth century drew to a close, manufacturers realized even greater cost savings by moving production to India and China.

In many cases, a new medicine or narcotic requires billions of dollars of investment before a single unit comes to market. As a result, it is incumbent on pharmaceutical companies to maximize profits not just to recoup prior investments but also to justify future investments in new medical and scientific research.

However, new biologics and complex drugs make offshore manufacturing both dangerous and difficult. The economic conditions of the late twentieth century that pushed manufacturing to other countries may still exist, but the requirements necessary for high-quality manufacturing and production have changed considerably.

Challenges in Offshore Manufacturing of Pharmaceuticals

Quality control in other countries rarely, if ever, meets the same exacting standards of the United States Food and Drug Administration. Generic versions of important drugs produced in faraway factories away from the watchful eye of the FDA come with quality variations that render treatments less reliable than originally designed. Different factories using different stocks of ingredients that originate from different locations are a recipe for pharmaceutical inconsistency and eventual ineffectiveness.  Additionally, the FDA requires a lengthy approval process for the importation of generic drugs manufactured outside of the United States, a regulation that interrupts supply in times of need and even the Mayo Clinic is on record opposing.

Offshoring also leads to a disconnect between where drugs are physically located and where drugs are needed by patients.  While a global health event like the COVID-19 pandemic was sure to influence the global pharmaceutical supply chain, the actual effects were impossible to predict. Disruptions in the supply of drugs to the United States started almost as soon as the epidemic broke out in the Wuhan province of China. Prescription drugs like Losartan, used to treat hypertension, were found in short supply as speculation that the drug could help combat COVID-19 made its way to the media. Of the 40 drugs necessary to actually treat COVID-19 patients, more than half experienced shortages in 2020 as doctors and frontline personnel fearlessly worked to treat patients around the country.

Benefits of Domestic Pharmaceutical Production

Health and Wellness

The health benefits of repatriating drug manufacturing to the United States are hard to overstate. First and foremost, access and availability of critical medications would improve as onerous import requirements and transit times would disappear almost entirely. Simply avoiding drug shortages whether during a pandemic or during calmer times would lead to more patients receiving the medications they need when they need them.

Access to medications without interruption is key to a healthy society.  Even more, in times of crisis having domestic production and supply of necessary drugs reduce American reliance on international customs officials, companies, factories, and governing bodies. Protecting the citizenry with access to needed medicine isn’t a political issue but rather an inarguable benefit that should be available to the population.

Job Creation

As with most any part of the manufacturing industry, bringing factories and distribution channels back to the United States would create thousands of jobs. Repositioning the USA as a global leader in drug production would also increase the gross domestic product and help balance foreign trade by repatriating many of the investments currently being made into an offshore workforce and offshore factories.

In addition to adding high-quality jobs to the economy, training and management of a domestic workforce at factories and facilities will lead to improved quality and consistency in the production of the drugs themselves. Pharmaceutical companies can assure that supplies continue to meet exacting quality standards to remain effective for patients by directly controlling not just the supply chain but also the actual workers managing production

Product Safety and Quality

By bringing manufacturing back to the United States, the most stringent regulatory body on earth for pharmaceuticals, the FDA, will be able to spot-check factories and ensure that product quality and integrity are not sacrificed. Make no mistake, higher product quality is not just about drug efficacy but also about drug safety. Higher standards of quality will eliminate potential contamination, further protecting those that need the drugs to stay healthy.

Improving quality and access to the medications and prescriptions Americans need has never been more important. During a time of crisis, it is critical that health professionals and patients have the pharmaceuticals necessary to bring them back to good health. By bringing drug production back to the United States, this issue of supply and demand can be greatly mitigated and controlled. Additionally, manufacturing in the United States means improved quality and safety controls as well as an increase in domestic jobs.

The Path to Domestic Pharmaceutical Manufacturing

While it is understandable that overseas production helps provide the necessary business model to invest in new drugs, there is a responsible balance that pharmaceutical companies must account for now more than ever. Domestic drug production does not necessarily invalidate that business model. Rather, producing drugs and medicine in the United States engenders business benefits that find their way to the bottom line in other ways. New jobs, higher quality, adequate quantities…each of these benefits of producing domestically has untold positive effects.