As many patients on medications know, drugs come in a “brand name” or “generic” form. The brand name drug gets a patent by the pharmaceutical industry and has about 12 years to capitalize on its success. Many drugs do not make it to market. At the end of the patent come the lawsuits to keep it a “brand” name as long as possible. Once the patent expires, everyone gets access to the ingredients and can then begin to produce it as a “generic name.” The FDA states that as long as the active ingredient is “80-125%” of the brand name, it can be therapeutically equivalent. This is interesting, especially when some patients state, “The generic doesn’t work for me”… and that is a topic for another time.

This is where things become interesting. The majority of generic manufactures are produced overseas, and this results in us, as Americans, depending on nations such as India, Israel, and parts of Europe for our meds. Even more alarming is that the raw starter materials come from China, which then get sent to India and the other nations above. The drugs get mixed and produced in labs overseas before finally arriving in the United States. Moreover, some 83 percent of the top 100 prescribed generics are import-dependent. The most alarming statistic is that China accounts for 95 percent of imported Ibuprofen, 70 percent of acetaminophen, and 40-45 percent of penicillin-based antibiotics (such as Amoxicillin). China and India account for 85 percent of filings for new active pharmaceutical ingredients. 

In a study published last year by Ghijs and colleagues, the authors compiled data from 2012-2023 that evaluated all recall information by the FDA. They identified 330 drug recalls a year, which noted an increased trend. They also noted:

“The most frequent cause of these recalls was found to be impurities and contaminants (37 %), followed by control (28 %) and labeling/packaging (19 %) issues. Recalls of medicines causing serious health problems or death (class I), accounted for 14 % of the recall events.”

As a community pharmacist, I saw these recalls and the impacts they have had on our country firsthand. I have seen recalls affect simple daily blood pressure and diabetes medications. I have also seen recalls on our antibiotics. I have seen the scramble to secure these medications, and the time and effort to get doctors to switch to other therapeutics. I know we have security and safety standards in our country, but do we really believe the FDA sends quality assurance agents to India and China, and that the labs are thoroughly inspected?

Perhaps COVID showed us that we really don’t know what is happening abroad, and we are better off assuring proper R&D here in the States. If these tariffs ultimately are enacted, I think it’s time we stop relying on other countries to provide medications for Americans and bring the manufacturing home. It would ensure national security and make sure proper regulations are followed. 

President Trump has said he wants to cut red tape and allow manufacturing here. There is no reason why incentives can’t be given to generic companies to allow for the majority of drugs to be made here, which can then allow us to be an exporter. The health of Americans is a high priority for President Trump and newly confirmed Health and Human Services Secretary Robert F. Kennedy Jr. If serious, this is a sure way to ensure Americans remain healthy and ensure we know what we are truly ingesting.