From time to time, news features on TV report a trend to “buy American”. The reports suggest that Americans are choosing items made in America over similar items made overseas. That’s admirable—right up there with “buy local”. But sometimes doing that to support our fellow citizens and to keep jobs within our borders may be easier said than done.
These news features made me think about our nation’s drug supply. What about those prescription products that we have in our medicine cabinets? Those pills, capsules and liquids we slosh down our gullets each morning, noon or night—where are they made? Certainly, they’re not made local, but are they even made on the North American continent?
We trust that any meds we consume are pure and safe, and as All-American as our favorite quarterback. But are they? As I pondered that question and the importance of prescription drugs in our modern world, I wondered if that trust was warranted or misplaced.
If the drug products are made on American soil, then we could assume that governmental oversight of the manufacturing facilities are in place. But what happens if the products are not made here? And how can we be sure that a drug product is safe to consume if it’s been made overseas? Who assures us of the quality of those drugs made offshore? Is it our government, the prescribing physician, the local pharmacy, or the distribution network that links the drug manufacturing houses to that pill bottle we pick up at the corner drugstore?
Statistics indicate that approximately 40% of all prescription drugs dispensed in the United States are made TOTALLY outside of the country, and 80% of all drugs dispensed in the U.S. have active ingredients (the main drug ingredient in the product) that ORIGINATE from sources OUTSIDE THE COUNTRY. Those are staggering statistics!
Why is there so much foreign drug manufacturing? American medical know-how and our scientists are surely the best in the world. But am I just lumping our trusted drug supply in with apple pie, ball games and hot dogs?
A reputable domestic drug manufacturer recently estimated that it costs about 25 percent more to manufacture generic drugs in the U.S. than overseas. As with most other things, it comes down to dollars and cents! That’s a sobering statistic, but it’s about much more than just pay differential or raw material costs.
With my past experience in pharmaceutical/herbal manufacturing, I know something about Good Manufacturing Practices. That’s the set of rules and procedures that manufacturing houses follow to assure the FDA and the public that the products they make are of expected quality and potency, and tests are made of the finished goods to confirm that. The FDA regulates that in several ways but conducting regular, periodic inspections tops the list for keeping everyone honest.
Reality begins to rear its ugly head when we link those percentages of drugs and active ingredients that are NOT made in the U.S. to the statistics of FDA oversight of foreign manufacturing houses. There are more than 3,700 foreign facilities that make finished drugs and/or active ingredients for the U.S. market, and the FDA admits to inspecting only about 11% of those facilities. By contrast, a U.S. drug manufacturing plant would be inspected about once every two years.
Such statistics could be a deadly combination moving toward a perfect storm of pharmaceutical disaster. And, when you read my first two novels, you’ll see what can happen when that combination turns sinister.
BUT there is good news! The FDA has been allocated additional funding for unannounced foreign inspections, and “surprise inspections” are a great way to keep everyone honest, even the antagonist characters in my novels.
The even better news is how the FDA controls the distribution of our nation’s drugs. Independent sources estimate that the U.S. drug supply is the safest in the world, with only about 1% of the drug supply not being consistent with what’s on the label. That means the drugs in your medicine cabinet have a 99% chance of being what you expect them to be.
The FDA, the DEA and other drug enforcement agencies at the state level monitor and regulate legitimate drug distribution throughout the process, from wholesale houses to local pharmacy inspections. And great care is taken by legitimate wholesale and retail operations to know the source of the medications flowing through their distribution pipeline. It’s good for their business reputation and great for our peace of mind. That’s why it’s so important to buy from reputable pharmacy establishments.
Thoughts? Comments? I’d love to hear them!
Hey James. Finally catching up with your latest post. Found your stats quite staggering, and I suspect not much different in my ‘neck of the woods’. Best option it seems is keep away from that stuff if at all possible. Thanks for another thoughtful post.
You might want to add generic drug manufacturers in the pot. Although governed by the same FDA rules, they are focused on producing a ‘bioequivalent’ product which is often of less quality. Also, some drugs have been found to contain little or no active ingredient, for reasons ranging from mistakes to outright fraud. It’s a dangerous world.
Wait till you read my 2nd book that will be published in the fall – talk about a dangerous world!!
This is kind of scary. Glad to know the FDA has been given additional funds to check out the foreign manufacturers more often. Thanks for the post, James.
You are welcome. Thanks for your comments!