PharmacyChecker pays close attention and has performed considerable research related to where drugs are made. Most notably, by researching drug labels and contacting drug companies, we found that 71% of brand name drugs sold in the U.S. are foreign made, a number far higher than the 40% figure regurgitated by the FDA year after year. Americans care a lot about this issue. One of our more popular Ask PharmacyChecker posts is called “How can I determine where a drug is manufactured?” But here’s something different to chew on: Even drugs that our research categorized as manufactured in the U.S. are often not really very “American.” In fact, many are categorized as imported and considered to be foreign-made pharmaceuticals by U.S. Customs and Border Protection (CBP).
I care a lot about this issue because Americans, the media and policymakers are victim to so much deception when it comes to the topic of drug importation and safety. Now, amid the global battle with Covid-19, questions about and problems related to where drugs are made are of even greater interest because now it is a question of national security. Many are worried that the U.S. has proved itself to be too dependent on drug imports from China. Although I for one can’t stand China-bashing or any unnecessary nationalistic rhetoric, that doesn’t mean we should be as reliant as we are on China for critical products such as life-saving pharmaceuticals.
For most Americans, however, cost is the biggest problem. The drugs Americans buy at local pharmacies, such as Walgreens or CVS, are sometimes 10 times more expensive than elsewhere for drugs that were not made in the U.S. Yet the FDA and Big Pharma warn consumers not to import the same drug even though it’s much cheaper if they order it online from other countries. (Even those drugs that are made in the U.S. are sold outside the U.S. at much lower prices).
This week, as reported in the NY Times, the U.S. government announced a $354 million contract with Phlow Corporation, a new pharmaceutical company, that will manufacture pharmaceutical ingredients domestically. The immediate goal of this federal spending is to make sure the U.S. has the pharmaceutical ingredients it needs to make drugs that treat people with Covid-19. The longer-term goal: bring back drug manufacturing to America for greater national self-sufficiency.
How dependent are we on China and other countries?
According to the FDA, 80% of our active pharmaceutical ingredients are foreign-made. Often unintentionally, false reporting has stated that China makes 80% of our active pharmaceutical ingredients (APIs.)
This is not true.
Eric Boehm published an article in Reason called – I love this – “Why You Shouldn’t Trust Anyone Who Claims 80 Percent of America’s Drugs Come From China.“
A more accurate assessment is that China and India’s APIs make up a plurality of those used to make drugs sold in America. I’ve written more directly here about the ubiquitous, media-worn out statistic that “80% of active pharmaceutical ingredients that make up ‘American drugs’ are imported.” That figure was used by the FDA back in the 1990s.
But what does this all say about where our drugs really come from?
The API of Januvia is called sitagliptin. Our research shows that Januvia is made in the United Kingdom. How do we know? The Januvia package reads “Formulated in UK.” According to the FDA, that means it is a product imported from the UK where its finished form was manufactured. The Januvia package also states “Sitagliptin (active ingred.) made in Italy.” According to the CBP, which processes the importation of goods into the U.S., Januvia is made in Italy.
Check out: Ben England, Esq. “Customs And FDA At Odds On Pharmaceutical Labeling.”
So, what about a drug identified on the label as being made here? Say, Zetia. Zetia’s API is called ezetimibe. The manufacturer’s stock label reads “Formulated in USA.” But above that it reads: “Ezetimibe (active ingred.) made in Singapore.” According to the CBP, that drug is imported from Singapore.
Now, here’ the thing. These particular labels are very transparent. Drug manufacturers are not forced to disclose where the APIs of their drugs are made. But I have yet to find a brand name label that states “made in China” or “made in India.” There are many thousands of drugs approved for the U.S. market, so maybe some do disclose this information, but most do not.
Janumet, a dual compound drug (two drugs – APIs – in one pill), contains the same API as Januvia, sitagliptin, and another API, metformin. The label just reads “Made in UK.” But it does not state where the APIs come from. I have a hunch why. We know Merck and Co. (the drug company that makes Janumet and Januvia) gets its sitagliptin from Italy to make Januvia, and it probably uses that same API to make Janumet. But Metformin is an off patent, widely-manufactured generic drug. It’s sold in the U.S. and many other countries under the generic name, not surprisingly, metformin. Metformin’s API is called… metformin. There are dozens of companies making the finished prescription drug called metformin, companies which are located in multiple countries, but many are in India. You can find this information in FDA’s Orange Book: https://www.accessdata.fda.gov/scripts/cder/ob/search_product.cfm. But we just don’t have a clue where the APIs for these finished drugs are made.
Furthermore, my discussion above has just covered brand name drugs. I believe that generic drug APIs are more likely to be made in China or India, and not in countries with the best reputations for pharmaceutical manufacturing (such as Italy). Keep in mind, lucky for us, there are many Indian and Chinese companies that make world class APIs. The problem is that too many do not.
So, the bottom line here is that the specific countries of manufacture of the majority of APIs are mostly unknown to us. And those APIs are used to formulate “domestically-manufactured” medicines. Without getting too far into it, the Federal Trade Commission recognizes this and thus prohibits the claim “made in America” unless the entire product or “virtually” the entire product is made here. How many of our domestically manufactured medications meet this standard? Very few.
While not that much, there is, in fact, domestic manufacturing of APIs. And this new Phlow company, noted above, is going to expand domestic production. They will make actual “American drugs.” But, as it stands now, almost all of our pharmaceuticals are imported.