Recently I saw an entertaining news feature about a family who was determined to fill their home with furniture and appliances made only in America. Once they had removed everything that WASN’T made in the United States, all that was left were a few odds and ends that fit neatly into a small camping tent. With a bit of Internet research, some time and a little old-fashioned determination, the good news is that the family finally was able to replace everything with items that were 100% “Made in America”.
That news report made me think about our nation’s drug supply. You know, those prescription products we have in our medicine cabinets? I’m talking about the pills, capsules and liquids we slosh down our gullets every morning, noon or night. Where do they come from? I’m guessing that the family I just mentioned never thought to look in their medicine cabinet for confirmation as to the source of any medications on hand.
We trust that the 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.
Who’s really responsible for the quality of those drugs? Is it only the manufacturing facility? Or is it our government, the prescribing physician, the local pharmacy, or the distribution network that’s the ultimate link between the drug manufacturer and that little pill bottle we pick up at the corner drugstore? I’ve done a bit of research and this is what I found.
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 so much foreign drug manufacturing? American medical know-how and our scientists are surely still the best in the world. But am I just lumping our trusted drug supply in with apple pie, ball games and hot dogs? Hmm?!
A reputable domestic drug manufacturer recently estimated that it costs about 25 percent more to manufacture generic drugs in the U.S. than overseas. It always seems to come down to dollars and cents, doesn’t it? That’s a sobering statistic, but the surprising part is that the comparison is about much more than just pay differential or raw material costs.
With my past history in pharmaceutical/herbal manufacturing, I know something about Good Manufacturing Practices. In the simplest sense, it’s a 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. (Remember I said that 80% of the drugs in our medicine cabinet may not really have a US pedigree) 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. However, the FDA has inspected only about 11% (as of 2009) of these facilities. By contrast, a U.S. drug manufacturing plant would be inspected about once every two years. Am I starting to scare you? I don’t mean to, but such statistics could be a deadly combination moving toward a perfect storm of pharmaceutical disaster.
However, there’s good news in all of this! Awareness of the FDA’s statistics regarding spotty oversight of foreign drug manufacturing has led to additional funding for unannounced inspections. As I’m sure you can imagine, these “surprise” inspections are a great way of keeping everyone honest.
And 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, and those are pretty good odds.
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 important not only for their business reputations but also for our peace of mind.
That’s why it’s so important to buy from reputable pharmacy establishments. Some of those online pharmacies? Maybe not so much oversight. I’m just saying!
Thoughts? Comments? I’d love to hear them!