Comments on - Quick Guide to the FDA - TIME
June 24, 2009
Topic: Miller Curtis & Weisbrod Blog
Link to Time Article - Quick Guide to the FDA
The article from Time that's attached shows what a huge job the FDA has - both in terms of the products and foods they are expected to regulate, and in terms of the significant health impact it can have on people all around the USA. From medical devices to pharmaceutical drugs to foods, the FDA is expected to keep track of all dangers and labels and products and so on.
The reality is, however, that each of the manufacturers of these products bear an even greater role in safety. Our system is designed to be self-policing, meaning that the makers of the products and devices and pharmaceutical drugs are expected to self-report problems. That system is one that requires mutual trust and honesty from the companies. Unfortunately, that trust is often violated, as the article points out. Drug makers are not currently required to report ALL studies of their drugs - meaning, they can perform a study and, if they don't like the results, simply put the article on the shelf. Doctors and patients would never know about the study.
Likewise, medical device makers will often promote their devices for things never approved by the FDA. And, the FDA simply doesn't have enough people and resources to keep track of every device and all the statements and suggestions made.
The FDA's new director is promising to take a more active roll, and require much more transparency from the companies. Such transparency will help to eliminate dangerous devices and poorly researched drugs from harming people.
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