As Americans courageously grapple with an invisible killer known as COVID-19, there is a raging debate in our country about what we should or shouldn’t do regarding the infectious outbreak. Nonetheless, there is one issue that has been resolved. COVID-19 and its devastating consequences has proven beyond cavil for once and for all that allowing drug manufacturing in the United States to nearly disappear in just two decades was one of the most embarrassing, arrogant, and foolhardy ideas ever coming to fruition. We must correct this disastrous blunder immediately.
Currently, the United States is only able to produce 28% of the active pharmaceutical ingredients (APIs) necessary for domestic consumption. APIs are the biologically active ingredients that are turned into medicines such as capsules, tablets, or injections. We have no choice but to import 72% of our APIs from countries on other continents. Indeed, while it’s alarming that America hasn’t manufactured any penicillin in almost twenty years, what should concern us now is that according to the Food and Drug Administration, over 200 drugs are in short supply.
“Right now, we have virtually no capacity in the United States to make even basic drugs for treating coronavirus, or antibiotics for infections that may come with it, including bronchitis or pneumonia,” says Rosemary Gibson, a senior advisor with the Hastings Center Bioethics Research Institute in an interview with the Washington Times.
The COVID-19 plague that has reached our shores now makes it glaringly obvious that the United States must take drastic and urgent measures to resuscitate our drug manufacturing industry. It is a matter of national security. We cannot continue to rely on countries that are facing their own dramatic health crises to be able to supply us with vital lifesaving drugs when they’re not able to produce enough for their own people. Moreover, even before the global pandemic, we had plenty of reasons to be alarmed at the health risks posed to Americans by prescription drugs produced under shoddy conditions with poor or nonexistent quality control measures.
While the Federal Drug Administration (FDA) can show up virtually unannounced for inspection at any U.S. facility, overseas facilities often get notice of inspections months in advance. Nonetheless, FDA inspectors are dedicated professionals regardless of where inspections take place. For example, during one investigation they discovered an elaborate plan to falsify quality control records at an overseas factory making the generic version of cholesterol drug Lipitor.
In another even more sobering display of the dangerous consequences of relying almost exclusively on drugs made abroad, the FDA uncovered that a large company overseas producing 29 different drugs was manipulating data and found evidence of possible cross-contamination. As a result of the inspections, the FDA banned all 29 of those drugs but had to issue exemptions for 14 of those same materials because the United States had a shortage.
Similar failures in quality control for products such as Heparin and Valsartan led to the deaths of hundreds of people. A third of the batches of Heparin sold to hospitals were contaminated, some Valsartan samples contained carcinogens. A serious problem encountered by the FDA is that foreign bureaucracies are resistant to complying with inspection protocols. While there may or may not be sinister motivations behind these institutional barriers, they are putting Americans at risk.
A nonpartisan bill sponsored by Senators Marsha Blackburn (R- TN) and Bob Menendez (D- NJ) known as the “Securing America’s Medicine Cabinet Act” (SAM-C), S. 3432, increases the FDA’s Emerging Technology Program and provides $100 million to develop centers of excellence for advanced pharmaceutical manufacturing to help produce drugs in the United States, aiding in the creation of domestic drug manufacturing jobs.
The bill would also establish an advanced manufacturing technologies unit within the FDA to prioritize issues related to national security and critical drug shortages. While this bill is a step in the right direction much more needs to be done and it is not a panacea to America’s overreliance on drugs made abroad, but it is a bill that Congress needs to pass right now. T
The COVID-19 epidemic has provided a wake-up call to the Country that when it comes to basic lifesaving medications, we can no longer be at the mercy of events happening in countries thousands of miles away. The disruptions caused by this pandemic prove that we need to end our helpless reliance on foreign countries for basic medicine. Continuing the status quo puts all Americans in jeopardy.
