America is objectively dependent on China and India for its drug supply. Recent reports from the FDA anticipating shortages of “critical medical products” due to the coronavirus outbreak highlight some of the risks that our dependence on foreign countries for medical equipment pose, but they fail to capture the critical extent of the threat.
China and India are the exclusive supplier for critical ingredients for dozens of crucial pharmaceuticals, including antibiotics, diabetes and heart-disease drugs, and high-blood pressure medicine. Essentially all generic drugs — which account for at least 90 percent of the drugs dispensed from pharmacies — rely on active pharmaceutical ingredients originating in China or India and on raw ingredients from China.
Other commentators have already written on the enormous national security risk that our reliance on foreign countries for life-saving drugs poses. We have handed control of our health and livelihoods to an economic and geopolitical competitor. But recent reports that China and India are shutting down their production of America’s generic drug supply due to the coronavirus have turned this fear into a reality.
The 1973 oil crisis, triggered by OPEC’s oil embargo, provided the United States with an opportunity to reevaluate its energy policy. It highlighted vulnerabilities in the existing supply chain and spurred our government to attain energy independence. Likewise, our current experiences with the coronavirus provide us with an opportunity to reevaluate our pharmaceutical policies. We should similarly work to attain medical independence.
Current FDA pharmaceutical regulations seem rigged to help drug companies produce cheap and low-quality drugs in China and India. The regulations unfairly target domestic drug manufacturers with draconian inspection and penalty regimes while effectively providing advanced inspection notice — in the form of visa applications — to Asian manufacturers. Even with the advanced notice, these manufacturers exhibit egregious violations with wholesale incompetence and profit-driven maliciousness or frank indifference to the scientifically sacrosanct manufacturing, sanitary and quality control standards in the United States and Europe.
Most readers will be surprised to learn that the FDA does not currently perform its own independent testing of drugs imported from foreign countries to ensure that the drugs contains exactly what it is supposed to contain and nothing else. Pharmacy insurances (PBMs) are unwilling to pay for private independent efforts, meaning that a vast majority of drugs go untested. PBM’s are also highly financially motivated to only purchase the cheapest generic drugs for its insured clientele. Valisure, the only pharmacy that does test these drugs, has uncovered mislabeling and even cancer-causing contaminations of our critical medicine.
Current regulations do not provide American consumers with transparency about the source of their pharmaceutical products. The current required labeling on prescription drugs in the US does not disclose the name of the manufacturer or the country of origin. Crucial information about contract manufacturing relationships between the drug’s manufacturer and marketer are completely hidden from public view. Obviously, most consumers would have serious misgivings if they knew they were ingesting drugs from India and China, coronavirous notwithstanding.
We all want safe and affordable drugs — but the current regulatory environment is in need of substantial reform.
The FDA must end its double standard and hold drug companies and their Asian manufacturers accountable for their widespread mislabeling and contaminations of critical pharmaceutical products. This will require a reform of the manufacturing inspection programs to ensure that Asian facilities do not received an unfair advanced warning and that they are subject to the same inspection rates and penalties as domestic facilities.
The FDA must stop relying on self-reported analytics and purity data from manufacturers and start requiring random independent testing on pharmaceuticals. It must ensure that our drug supply is safe and that patients can be confident that the drugs they are taking contain exactly what they are supposed to and are not contaminated with impurities. This will require a pharmaceutical testing process of every drug coming out of America’s pharmacies.
The FDA must demand increased transparency on prescription bottles so that patients know where their drugs are coming from. President Trump is on the right track with his Buy American Executive Order, but we will still need labeling clarification on the stock and consumer prescription bottles on where reagents, active ingredients and final manufacturing actually take place. This information is not present or deceptively confusing as of now. The FDA and White House must force drug companies and pharmacies alike to publically disclose contract manufacturing relationships between the drug manufacturers and marketers. This will require increased disclosure regulations and requirements.
And most importantly, the FDA should prioritize ensuring that the United States has the requisite capability to produce its own raw materials and critical medical products. Medical independence is just as crucial for our national security and geopolitical autonomy as energy independence is.
In 2004, the last plant in the United States to manufacture the key ingredients for crucial antibiotics, including penicillin, closed. It is unconscionable that the United States can no longer independently produce penicillin, one of its greatest medical inventions. It is inexcusable that our elderly veterans — the very ones who fought for our freedoms in WWII and helped build this country to what it is today — are now reliant on a geopolitical rival for life-saving medicine. And it would be unforgivable for us to continue to gamble our health and security on the whim of a communist dictatorship.
Dr. David Gortler is a former FDA Official and is an FDA drug safety and FDA regulatory affairs expert. He was also the former FDA/health care policy adviser for the 2016 Ted Cruz presidential campaign.