Today, the Houston Chronicle ran the following Op Ed, which uses the word "lax" in describing FDA inspection, and suggests that the Agency is assuming an "honor code" for drug manufacturers, suggesting a trend in how people are viewing FDA. The word "underfunded" would have been a better choice, but it is true that the Agency can't inspect facilities outside the U.S. as frequently as it, ideally should.
What options are there? USP has launched an ingredient verification program, and a subsidiary in India to maintain standards for ingredients.
FDA needs to stop using pharmaceutical honor system
BY JOE GRAEDON and TERESA GRAEDON
King Features Syndicate
One of Ronald Reagan's most memorable quotes was "Trust but verify." He used this phrase dozens of times when speaking about U.S. relations with the Soviet Union.
In his farewell speech to the nation after two terms in office, President Reagan cautioned: "It's still trust but verify. It's still play, but cut the cards. It's still watch closely. And don't be afraid to see what you see."
We only wish the U.S. Food and Drug Administration would heed Ronald Reagan's advice. For far too long the FDA has relied on the honor system when it comes to pharmaceuticals. Nobody's "cutting the cards."
The agency trusts drug companies, wholesalers and drug distributors to be honest. The FDA does not verify that the bottles on pharmacy shelves contain the medications on the label.
In other areas where lives are at stake, there is a reliable verification system. If you build a house in America, the local municipality periodically sends a building inspector to make sure your contractor is following code regulations.
Although the FDA is supposed to send inspectors to check up on pharmaceutical manufacturing plants every couple of years, the agency does not routinely pull pills off pharmacy shelves to verify ingredients and potency. Based on what the agency has told us, officials examine only about 300 bottles a year. That's out of more than 3 billion dispensed, which boils down to one bottle per 10 million sold.
With such lax verification, it is not surprising that some greedy pill-pushers might try to get counterfeit medicines into the marketplace. There is no organized system in the United States to check for these black-market medicines.
We have heard from hundreds of readers who report that their generic drugs are not working as well as the brand name did. We worry that counterfeiters may have penetrated this marketplace.
A reader recently shared this: "For many years I took Vasotec, which kept my high blood pressure around 150/90. When a generic became available, I was given enalapril. I experienced a pounding in my head, which felt like it would explode. My heart felt like it was stuttering. My blood pressure was 210/110. I immediately went back to Vasotec and over the next few days the symptoms disappeared.
"Upon further investigation, I learned that the enalapril I was taking was manufactured in India. The Vasotec came from Canada."
Few Americans realize that many of the raw materials for their medicine come from India and China. A few weeks ago, the past head of China's FDA was arrested on charges that he had accepted bribes to approve counterfeit drugs. Corruption within that agency will require investigation of 170,000 production licenses issued during the past decade.
No one knows if that includes medicines sold in the U.S., whether brand or generic.
Anyone who has experienced a generic drug problem may report it on our Web site (www.peoplespharmacy.com). You will also find there our new book, Best Choices From The People's Pharmacy (Rodale Books), with an in-depth discussion of the generic-drug issue and guidelines on how to use such medicine safely. If the FDA isn't up to the task, consumers will have to trust but verify.