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Why Don’t Drug Shortages Happen in Other Countries?
The FDA maintains that price controls aren’t the problem and that its system for inspecting and certifying production facilities hasn’t changed. Rather, it’s the companies’ manufacturing issues that account for the majority of the drug shortfalls, the FDA says.
Because most generics are older drugs that have been around for many years, they tend to be made in older facilities that have not kept up with the latest standards, making them more vulnerable to violations of FDA requirements.
The Generic Pharmaceutical Association (GPhA), however, says that in recent years, inspections have become harder to pass.
“From the industry’s perspective, the FDA has been much more aggressive in their inspection formats over the past two to four years,” says David Gaugh, senior vice president for regulatory sciences at GPhA, who has had experience at a generic manufacturer.
WASHINGTON -- A growing shortage of medications for a host of illnesses -- from cancer to cystic fibrosis to cardiac arrest -- has hospitals scrambling for substitutes to avoid patient harm, and sometimes even delaying treatment.
"It's just a matter of time now before we call for a drug that we need to save a patient's life and we find out there isn't any," says Dr. Eric Lavonas of the American College of Emergency Physicians.
Some experts pointedly note that pricier brand-name drugs seldom are in short supply. The Food and Drug Administration agrees that the overarching problem is that fewer and fewer manufacturers produce these older, cheaper generic drugs, especially the harder-to-make injectable ones.