Do you swallow any pills in the morning? We would be surprised to learn that you don’t. Most Americans swallow a handful without even thinking. Let’s start with vitamins. Millions of people take B vitamins along with C and D. Then there are dietary supplements like turmeric (curcumin), calcium, magnesium, glucosamine, CoQ10 and probiotics. Many people take pain relievers (NSAIDs) like ibuprofen or naproxen along with acid-suppressing PPIs, blood pressure pills, diabetes drugs and cholesterol-lowering medicines. Do you have a clue where your pills are made?
Once Upon A Time:
There was a time when most prescription and over-the-counter drugs were made in the USA. That included both brand name and generic medications. The FDA made a concerted effort to inspect manufacturing facilities on a regular basis.
These visits were not announced in advance. That always made sense to us. No one would want a drug manufacturing company to know the inspectors were coming. That way FDA officials could see what was really going on in the facility. You would not want the local health department to notify restaurants in advance that they were planning to inspect the kitchens.
Where Your Pills Are Made Today:
Over the last two decades, the pharmaceutical industry has changed dramatically. Manufacturing of many medications has shifted overseas because it is cheaper to make medicines in China, India, Thailand, Slovakia or Brazil.
The Story of Aspirin:
A decade ago Gardiner Harris wrote a compelling article for the New York Times Magazine titled “The Safety Gap” (Oct. 31, 2008). His first paragraph tells the story of aspirin:
“In the belly of an industrial district south of Lyon, France, just past a sulfurous oil refinery and a synthetic vanilla plant, sits a run-down, eight-story factory that makes aspirin, the first pharmaceutical blockbuster. The Lyon factory is the last of its kind. No other major facility in Europe or the United States makes generic aspirin anymore. The market has been taken over by low-cost Chinese producers. Even Bayer, the German company that created aspirin in the 1890s and has fought for more than a century to distinguish its product as the most trustworthy one, now has backup supplies from China.”
Mr. Harris went on to point out in 2008 that “China now produces about two-thirds of all aspirin and is poised to become the world’s sole global supplier in the not-too-distant future.”
How would you know where your aspirin is made? Certainly not by looking on the label! What about acetaminophen, ibuprofen or naproxen. Do you have a clue where your vitamin D3 comes from or your vitamin C? Chances are you don’t. There is nothing on over-the-counter drugs or dietary supplements to tell you where your pills are made.
Where Was the FDA?
The FDA was slow to respond to the outsourcing of pharmaceuticals. It took years for the agency to figure out how it might assess foreign-based facilities. Countries like China and India require notice far in advance before an inspection can take place.
We’ve never understood why the FDA tolerates such limitations. If a country wants to export its pharmaceuticals to the USA, shouldn’t it have to play by the same rules as American-based manufacturers?
FDA Warning Letters: Form 483
Even with advanced notice, many foreign manufacturers have received warning letters from the FDA. The Food and Drug Administration labels such warnings a Form 483. What this letter typically means is that the company has violated an FDA rule. It might have to do with manufacturing or misinformation.
Companies that have received warnining letters from the FDA include Wockhardt, Ranbaxy, Dr. Reddy’s Laboratories, Aurobindo, Sun Pharmaceutical Industries and Fosun Pharma. In some cases the agency detected deviations from good manufacturing processes and kept some of their drug products from being sold in the US.
The Valsartan Debacle:
This summer, valsartan blood pressure pills were subject to a world-wide recall. The problem pharmaceuticals contained an active ingredient made by Zhejiang Huahai Pharmaceutical Company in Linhai, China. The company had changed its manufacturing process and as a consequence the medicine was contaminated with a probable carcinogen, NDMA. This problem had gone undetected for years.
More recently, a US subsidiary of an Indian company, Accord Healthcare, mislabeled bottles of blood pressure medication. The label said hydrochlorothiazide 12.5 mg. The pills actually contained spironolactone 25 mg. For some patients, this mistake could have been a life-threatening error. These two drugs have very different effects on the mineral potassium. Hydrochlorothiazide depletes the body of potassium, while spironolactone can raise potassium levels.
Readers Want to Know Where Your Pills Are Made:
One reader wrote:
“HCTZ was prescribed to lower my idiopathic high potassium level. I am beyond grateful for your column addressing the recall of Accord’s generic formula. I’m concerned that this medicine could be having the opposite effect of its intended one.”
Many people would appreciate knowing where their pills come from. One woman tried to do her homework:
“I take losartan. With the recall of valsartan, I wanted to see where my own drugs were manufactured. I happen to have two generics in my cabinet, one being a new refill.
“I called CVS. The pharmacist could only find the location of one of the drugs. It came from India, although it had a US drug company on it until you probed further. She could not find the origin of the other generic pill, but she gave me the phone number for the drug company. I called and they would not tell me where the drugs where manufactured. They said it was basically their secret.
“The drug companies do not have to make the country of origin public knowledge. I am appalled by this. It needs to change!”
Another reader expressed an opinion that many share:
“All drugs sold in the US should be labeled as to country of origin for all ingredients. We need Congress to pass a LAW to that effect ASAP!”
The People’s Pharmacy Perspective:
We believe that all pharmaceuticals and dietary supplements should have country of origin information on the label in print that anyone can read. We also recognize that this is complicated. The active pharmaceutical ingredient (API) in any pill is the most important component. But there are other ingredients as well. They include binders, fillers, coloring agents, etc. These are referred to as excipients or inactive ingredients.
A blood pressure API like lisinopril might be made in China. But the other inactive ingredients might come from Slovakia or Pakistan. The final pill could be manufactured in India. What should go on the label? We think there are two essential factors: Where did the active pharmaceutical ingredient (API) come from and where was the pill formulated? At most, that would be two countries. That’s not so difficult.
Chain pharmacies might decide that their customers would like to purchase vitamins, over-the-counter medications and prescription drugs made in a country where FDA inspections are unannounced.
What do you think? Share your own perspective on where your pills made. Do you think country of origin information should be included on vitamins, dietary supplements and pharmaceuticals?