COVID Relief Package Missed Golden Opportunity to Mitigate Vital Public Health and Security Threat

Center for Security Policy Exclusive Analysis

The $1.9 trillion COVID relief package signed into law by President Biden on March 11, 2021 missed a golden opportunity to mitigate a public health and national security threat of epic proportions: China’s global chokehold on the critical inputs to produce thousands of generic drugs including those to treat seriously ill people with COVID.

Last year’s COVID spending bill, enacted during the peak of the pandemic as hospitalizations soared and doctors rationed drugs, also failed to shore up domestic production of vital medicines.

Even with China’s threat to withhold antibiotics from the American people during the pandemic, this wake-up call was not enough to ignite Congress to support America’s collapsing manufacturing infrastructure for antibiotics and other medicines necessary for survival.

Consequently, well-known risks are unabated. In the Strategic National Stockpile, 80 percent of the products depend on components made in China. In an emergency, the U.S. cannot replenish the stockpile on its own.

Meanwhile, as the U.S. dithers in shoring up domestic production, the safety risks of imported generic drugs from China have escalated exponentially. In February 2020, the FDA recalled all of its manufacturing facility inspectors from around the world to protect them from COVID. Inspections are fundamental to FDA’s mandate to protect the public.

For more than a year, the United States has been importing unregulated medicines from China and elsewhere and distributed to hospitals, the military, and the VA. This increases the risk of contaminated drugs or products with no medicine in them. The FDA rarely tests imported drugs.

A hearing on March 9, 2021 in the U.S. House of Representatives on FDA inspections chronicled the familiar failures that have plagued the agency for years. Regrettably, no one was there to tell Congress the truth that FDA’s future in China is bleak. FDA employees volunteer to conduct overseas inspections and the agency has had problems recruiting inspectors.

Imagine an FDA inspector who identifies safety violations that cause a Chinese company to lose millions of dollars in sales when the FDA bans its products from the U.S. The Chinese government is unlikely to grant any more visas to this FDA employee.

Adding to the problem, the recent humiliation of U.S. diplomats with anal COVID testing is another reason FDA staff may not want to volunteer to travel to China.

There is a potential bright spot in the COVID relief package just signed: $10 billion in federal funding for the Defense Production Act. It should be invoked to support domestic production of essential generic drugs and their key components, a priority acknowledged in the Administration’s Executive Order on America’s Supply Chains.

The Executive Order calls for a report on the risks to the supply chain for drugs and their key ingredients, and recommendations to mitigate the risks. Right now, enough is known about the problem and solutions to launch immediate action:

• use the Defense Production Act to restart U.S. manufacturing of generic antibiotics which are fundamental to medical care, public health preparedness, and biodefense.
• require all federal departments and agencies including the Department of Defense, Department of Health and Human Services, and the Veterans Health Administration to prioritize purchases of essential generic drugs, as defined by the FDA, from domestic manufacturers with preference to companies producing active pharmaceutical ingredients and their critical inputs in the United States.
• invest in advanced manufacturing of generic drugs using technology that lowers production costs and has a smaller environmental footprint.

The rationale for federal support for essential medicines production is that they are a strategic asset for the nation. Food and energy are treated as strategic assets because the country would cease to function without them. The same is true with medicines.

Also, U.S.-based manufacturers are not competing with Chinese companies. They are competing with the Chinese government, a race they cannot win without a long-term partnership with the federal government. This partnership is also needed to help curtail China’s infiltration into the nation’s civilian and military healthcare systems.

Millions of Americans, Democrat and Republican, rich and poor, bet their lives every day that the five-cent pill that can save their life is made according to the standards we have come to expect. This is not too much to ask. And the problem is eminently fixable.