MADE IN AMERICA: What About Our Prescription Drugs?

From time to time, news features on TV report a trend to “buy American”. The reportsMH900177764 suggest that Americans are choosing items made in America over similar items made overseas. That’s admirable—right up there with the “buy local” slogans. But sometimes doing that to support our fellow citizens and to keep jobs within our borders may be easier said than done.

MH900321090These 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 governmentalMH900400871 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 the pay differential or raw material costs.

MH900321072With 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 made are of expected quality and potency, and that 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.

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.

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 andMH900431268 regulate legitimate drug distribution throughout the process—from the wholesalers 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!

About James J. Murray, Fiction Writer

With experience in both pharmaceutical manufacturing and clinical patient management, medications and their impact on one’s quality of life have been my expertise. My secret passion of murder and mayhem, however, is a whole other matter. I’ve always loved reading murder mysteries and thrillers, and longed to weave such tales of my own. Drawing on my clinical expertise as a pharmacist and my infatuation with the lethal effects of drugs, my tales of murder, mayhem and medicine will have you looking over your shoulder and suspicious of anything in your medicine cabinet.
This entry was posted in About James J. Murray, About Medications/Pharmacy, Are Generic Drugs Safe, Blog Writers, Blogging, FDA and On-Line Pharmacies, Generic Drug Manufacturing, Generic Drug Safety, Generic Drug Use, Generic Drugs, Generic Drugs in the US, Made In America, Medication Safety Issues, Offshore Manufacture of American Drugs, Our nation's drug supply, Pharmacy/Pharmaceuticals, Prescription Drug Safety, Prescription Fill Practices in the US and Canada, Prescription Trends, The American Drug Supply, The Pharmacy Profession, Where Are America's Prescription Drugs Made? and tagged , , , , , , , , , , , , , , , , , , , , . Bookmark the permalink.

8 Responses to MADE IN AMERICA: What About Our Prescription Drugs?

  1. Jim Burk says:

    James,
    This is a great overview and perspective on manufactured drugs, and the safe guards by the
    DEA and FDA, in the United States. Well written

  2. Arlee Bird says:

    There needs to be greater diligence about what is coming into this country from elsewhere. Sometimes I feel like the U.S. is selling it’s birthright in exchange for cheap burgers and fries.

    Arlee Bird
    A to Z Challenge Co-host
    Tossing It Out

  3. James, a thoughtful discussion of a topic important to all of us. Many thanks.

  4. Appreciate the comments, Jim, Jim and Arlee Bird. All the best to you guys.

  5. I find it hard to trust anything that comes from our government agencies. Money buys credibility. Sad for me to say this as I once was a trusting soul.

  6. Another awesome and important post. Keep up the good work, James!

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