In a post I put up last September, I asked “What Is Going On With The FDA??”
Thanks to a couple of articles I figured it out.
There’s a reason it takes so many years for the FDA to take action against “dangerous” drugs like children’s cold meds, Rocephin, and Haldol. These drugs have all been on the market for more than 15 years and in just the past six months, the FDA came to the conclusion that they were all a threat to American lives.
Enter the GAO.
In a New York Times article, government investigators have just reported that the FDA is woefully understaffed. The article stated that at the FDA’s current staffing level, it would take more than 13 years to check every foreign drug manufacturing plant, and more than 1900 years to check every foreign food manufacturing plant. No, I didn’t have a nervous twitch on the “0” key. The article states “one thousand nine hundred” years to check all the foreign food manufacturing plants. In fact, the FDA computer systems are so bad that they can’t even create a list of which plants have been inspected and which have not.
A Wall Street Journal article reported that the FDA can’t even keep up with inspection of domestic manufacturers of medical devices (like defibrillators and contact lenses).
A former lawyer for the agency stated that “This is a fundamentally broken agency, and it needs to be repaired.”
So it isn’t like Big Pharma is paying off the FDA to approve drugs while they are on patent and then put danger labels on them when they are off patent (and no longer earn the drug
cartels companies any money). It’s just that the FDA is so overworked that 15 years is about how long it takes until they can review a drug’s safety profile.
Doesn’t that make you feel better?
Hat Tip to ACEP‘s Emergency Medicine Today