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Welcome to Andy’s Take.
This week you may have heard on radio or TV, or read in the newspaper, about a controversial issue involving medication taken for asthma. Scientists and experts debated the risks and benefits of taking long-acting asthma drugs that are used by millions of patients throughout the world.
My Take is that this illustrates the dilemma faced every day when the FDA must make decisions about the medical products you use. Science can help to measure the risk and benefit of a certain drug, but the decision on whether it is appropriate for you to use it involves subjective judgment. To a scientist or medical expert looking at the issue, the risks may appear to be too high, but to a mother with an asthmatic child struggling to breath in the middle of the night, only the benefit seems to matter.
When approving a drug for market, our decision on where to draw the line is difficult, but the FDA cannot just debate -- it must decide. We do this through a laborious process. FDA acquires a myriad of complex data, analyzes it and assembles it into information about performance in a clinical setting, and translates it into knowledge of risk and benefit upon which we can make a sound regulatory decision. The process involves multiple disciplines and can be contentious and at times even require formal resolution of conflicting scientific opinions. Using the best science to inform debate among the best available experts -- both inside the agency and in our external advisory committees -- is the way FDA makes these challenging decisions. This occurs each and every day with every drug, every vaccine, and every medical device – literally thousands and thousands of products that your health depends on.
So, next time you pick up your prescription or get an over-the-counter medication or product from the drugstore, you can take comfort knowing that a disciplined and exhaustive effort was made to ensure the safety of the product you purchased – and that FDA experts had meticulously weighed its risks and benefits to protect and promote the health of you and your family to the best of their ability. All of us owe thanks to these dedicated public servants for accepting, and conscientiously carrying out this great responsibility.
Andy
Andrew C. von Eschenbach,
M.D.
Commissioner of Food and
Drugs
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