One of the most basic expectations of government is the health and well-being of our nation. Yesterday, in a timely subcommittee hearing, I asked an Inspector General of Health and Human Services this question: “Are our drugs safe?”
The raging coronavirus has called attention to a much-overlooked problem. In the name of global profiteering, we’ve enabled the dangerous outsourcing of pharmaceutical production to foreign countries—a significant portion of it to the very place of origin of coronavirus in China.
Over 80% of active drug ingredients and 40% of finished drugs on the American market – from ibuprofen to reduce your fever to antibiotics to treat your infection – are produced outside the U.S. Even if we vigilantly inspect the domestic manufacturing process, we cannot possibly get a handle on drug safety when our drugs are sourced from over 150 countries, including China and India.
The Department of Health and Human Services (HHS) has a daunting task in managing the spending and performance of agencies so large they can be bigger than some countries. One of those agencies is the Food and Drug Administration (FDA). There is an inherent and unfair duality, however, in how FDA’s foreign and domestic inspections are carried out. FDA inspectors routinely conduct surprise inspections in the U.S. to ensure that drug companies are producing medicine in a safe, clean, and responsible manner. But when it comes to foreign inspections, the FDA customarily gives companies advance notice, often as much as 12 weeks, enabling drug suppliers plenty of time to clean up their acts. That is counter-productive, wrong, and creates an unlevel playing field for companies trying to manufacture drugs in the U.S.
Compounding these problems, FDA inspectors also face obstruction, coercion, and deception in foreign countries. In one case, a Chinese company reportedly imprisoned an inspector in a conference room for an hour as it tried to force her to destroy photographs she took of its facilities.
Inadequate monitoring of foreign production of medicine has dire consequences. In 2008, a tainted batch of the blood thinner heparin, made in China, killed over 100 people worldwide––including 81 in the U.S.––leading to the drug’s recall. In August 2018, the FDA issued an alert that a Chinese manufacturer of porcine thyroid, used to treat hypothyroidism (underactive thyroid), was recalled due to inconsistent quality.
At the hearing with the HHS inspector, I asked why so much drug production has moved overseas. I already knew the primary answer, of course––to capitalize on low wages and lax environmental, safety, and labor standards in those countries. My fuller intention was to probe whether or not U.S. law and regulatory structure may perversely encourage offshoring.
These troubling dynamics take on special urgency given the spread of coronavirus (COVID-19). The FDA has identified 20 drugs that exclusively source active pharmaceutical ingredients or finished drug products from China. The agency just issued an alert that at least one Chinese drug-maker has ceased production of a human drug due to coronavirus infection at a manufacturing site. Drugs with short expiration dates are particularly vulnerable to these supply-chain disruptions.
Solving these issues becomes easier when we can fully identify and inspect foreign sources of medicine. But with the bulk of our foreign drug supply originating from a country that suppressed news about the origins, severity, and timing of coronavirus––and to this day prevents our Centers for Disease Control and Prevention from accessing the actual virus––I am not optimistic.
We need clearer answers about how we oversee the foreign production of drugs and drug ingredients. We also need the right incentives to ensure that U.S. companies will produce more drugs and drug ingredients right here at home. If it’s Made in America, we can all feel much better about knowing it’s safe.
Congressman Jeff Fortenberry is the Ranking Member of the House Appropriations Subcommittee on Agriculture, Rural Development, and Food and Drug Administration (FDA) and a Member of the House Appropriations Subcommittee on State and Foreign Operations.