January 21, 2019
Peter Pitts, former associate commissioner at the US FDA and president of the Center for Medicine in the Public Interest, discusses why the FDA pulled a large quantity of a blood pressure drugs off the market and why it is important to understand.
Hello, my name is Peter Pitts. I'm a former Associate Commissioner at the US FDA and I'm President of the Center for Medicine in the Public Interest.
You might have read or heard about blood pressure medicines being withdrawn from the market. Why is that important to understand in context?
When medicines in the US go off patent, generic competition enters into the equation. That's a wonderful thing. It introduces drugs that are of high quality, that are safe and effective, and approved the FDA, but that can cost upwards of 90% less than the innovator products.
Why are these drugs being taken off the market? Well, there are a couple of reasons. Firstly, sometimes when a competitor makes a generic product, there are problems in manufacturing. The result is that adverse events happen or that positive therapeutic outcomes don't happen as they're supposed to.
These types of situations are regularly monitored by the US FDA as part of their job in pharmacovigilance. When they come across these situations, they ask the manufacturers to withdraw their products from the market, fix the problem, enhance the quality, and put the drug back on the market.
This maintains both competition and quality, which is the dual seesaw, in effect, that allows Americans to benefit from generic drugs.
Rather than being concerned or upset when these drugs are being taken off the market, it's important to understand that it represents the FDA doing its job in collaboration with industry, to make sure that generic drugs remain high quality, safe and effective.
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