In 2008, the FDA received reports of serious reactions, including fatalities, among patients undergoing dialysis treatments. An FDA-led investigation found that heparin, a drug used to treat kidney failure, contained a contaminated ingredient originally sourced from China, sparking congressional hearings and igniting nation-wide concern about drug regulations in foreign facilities. Weeks ago, a generic form of Xanax, a popular anti-anxiety medication, was recalled because it’s suspected to contain an unspecified “foreign substance”. While an investigation is still ongoing, both of these incidents, more than a decade apart, indicate that our growing dependency on China for drug manufacturing is having serious public health and national security consequences.
China is now the world’s largest supplier of active pharmaceutical ingredients (APIs), which are the key ingredients used in the production of a drug. The majority of APIs are produced abroad, meaning that for most Americans, their drug cabinets likely contain a medication with foreign-based APIs. China has been able to monopolize the market largely because their government plays an active role in maintaining low labor costs and turns a blind eye to regulations other countries adhere to. Because these APIs have the financial backing of the Chinese government, American pharmaceutical companies are unable to remain competitive and are forced to purchase APIs in China instead of producing their own.
Perhaps what makes this situation even more alarming is the lack of information the FDA receives on API’s from China. In order to assess the safety and national security risks associated with China’s API monopoly, we need clear information regarding the level of U.S. dependence on foreign-produced drugs, and we need a clear understanding of how resilient America’s manufacturing base is. Unfortunately, the FDA appears unable to answer either of these questions because they lack key information. If the FDA lacks the ability to make key determinations regarding American-manufactured pharmaceuticals, it makes threat assessment and our ability to rectify the problem all the more difficult. In order for Congress to address our dependence on foreign APIs, we must give the FDA the tools it needs to properly monitor and inspect foreign API facilities.
While this can help ensure our drug supply is safe, it doesn’t provide a long-term solution for limiting our dependence on China. It’s clear that more needs to be done to bring back API manufacturing to the U.S. The FDA recognizes this and has launched an advanced manufacturing initiative to stop the loss of manufacturing to China, improve drug quality, and reduce drug shortages. Advanced manufacturing can enable manufacturers to produce drugs at a much lower cost and with a lower environmental impact, and the FDA is working to reduce the regulatory hurdles by streamlining the application process and engaging with manufacturers as this process evolves.
By following the FDA’s advanced manufacturing initiative to employ the use of technology to improve and streamline production, the U.S. has a better chance of producing reliable and safe materials we can use to manufacture our own medications. The FDA’s initiative is a great start, but this is a long-term problem that requires long-term solutions. I look forward to working with my colleagues on the Energy and Commerce Committee to revitalize drug manufacturing here at home.
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