Warning – Don't Confuse 'Made In USA' And 'Inspected By FDA' With Patriotism
By Rob Wright, Chief Editor, Life Science Leader
Follow Me On Twitter @RfwrightLSL
A big concern for the pharmaceutical industry is the willingness of insurance companies to continue to reimburse at a level significant enough for pharmaceutical and biotech companies to continue heavy investment into R&D, and thus drive U.S. medical innovation. You only need to look at how buying those cheap goods made in China and elsewhere has impacted the loss of U.S. manufacturing jobs and our ability to recover from the Great Recession. Recently however, American consumers have begun to realize the error of their ways, and have begun seeking products labeled “Made in the USA.” This year, Walmart (NYSE: WMT) announced its intention to boost sourcing of U.S. products by $50 billion. General Electric (NYSE: GE) is investing $1 billion through 2014 to revitalize its U.S. appliances business, creating more than 1,500 U.S. jobs. Imagine a similar scenario in the drug industry.
Drug Re-Importation Circumvents Citizen Safety
During recent U.S. presidential elections, the topic of the high cost of drugs tends to be a favorite amongst politicians. Some view prescription drug re-importation amendments as being a “common-sense” solution to the problem of “overinflated U.S. drug prices.” These individuals propose bringing drugs in from Canada and elsewhere, claiming they are exactly the same but cost less. This is a total fallacy. Drugs manufactured outside of the U.S. and sold outside of the U.S. have not necessarily been subjected to the same scrutiny (i.e. inspection by the FDA) as products sold for consumption by U.S. citizens. Thankfully, last summer, an amendment cosponsored by John McCain and Sherrod Brown failed to pass through the Senate, to the disappointment of those people less educated about the lower-quality pharmaceutical manufacturing standards of some countries. I am not saying we should only buy U.S.-manufactured drugs. However, I am saying that buying drugs that have been approved for distribution through legitimate channels by the FDA is very important. In fact, your life may depend upon it.
In an open letter to the public, John Castellani, president and CEO of PhRMA, asks if you have ever asked your doctor or pharmacist if your medicine is real or counterfeit? “Probably not, nor should you have to,” he writes. According to Castellani, American patients currently enjoy peace of mind knowing their prescription medicines are safe and effective. John Clark, VP and chief security officer for Pfizer, notes that the danger isn’t necessarily counterfeiters deliberately trying to poison a patient but something he views as being far scarier. “I've seen counterfeit versions of all types of medicines,” he wrote in a Huffington Post blog. “Counterfeiters have become more and more adept at manufacturing fake medicines that are increasingly realistic-looking – duping patients who think they're getting the real thing.” According to Clark, counterfeits typically do not contain the approved dose of the active pharmaceutical ingredient. This can deprive patients of the intended therapeutic benefit, resulting in what he describes in a video interview as a “slow, quiet death.”
FDA Equals Safety
The FDA is the oldest comprehensive consumer-protection agency in the U.S. and sets the standard by which other countries measure their quality of drug manufacturing. Legitimate foreign drug manufacturers interested in importing medicines legally to the United States must have their facilities pass FDA inspection. Passing laws which legalize drug re-importation not only enables counterfeit drug activity, but also incentivizes legitimate foreign-based drug manufacturers to not have to abide by FDA standards. Why do you think many drugs which American consumers want to re-import cost less? They are manufactured to lesser standards of quality. Don’t confuse “Made In USA” and “Inspected By FDA” with being patriotic. Both symbolize one thing – quality. However, “Inspected By FDA” also symbolizes safety.