Headaches

The FDA received funding to increase its workforce at the CDRH for 2012 and 2013. They have set aggressive goals to improve the turnaround times for 510K approval. They have instituted programs to retain their employees and to increase the reviewer to manager ratio. My colleagues and I were very excited to hear about it. These changes will make things better for the public and smoother for us, especially after these new employees are fully trained. Good news, right?

However, I happened to mention this to my husband. He believes in less government, less taxes. To him, my good news was bad news. What he heard was that there were more tax dollars involved. My simple statement opened up a torrent and a debate. He believes that the FDA should decrease their workforce by proving that products are safe, but not worry if they are effective. In this way they can cut their efforts and costs in half. So, basically he believes that if you take an aspirin, it is the FDA’s obligation to make sure that it won’t harm you. However, he doesn’t think that the FDA should invest any time evaluating if it truly gets rid of your headache. He thinks it is up to the manufacturer, doctors and consumers to feed data back to prove that the product is effective. It is an interesting viewpoint, but I have to disagree. And since this is my blog and not his, I get to have the last word – at least in print.

I think the current system that the FDA uses to monitor medical device manufacture is necessary. In an ideal world, manufacturers would be diligent and spend the money necessary to make sure that their devices are safe and effective. But I have seen the industry up close. I believe that corners would be cut if the FDA was not so rigorous. Early in my career I worked for a small company that would not have done the due diligence necessary to make a safe and effective product, if it wasn’t required by law. I, for one, want to know that my asprin is really effective at treating my headache - especially if the headache was caused by an opinionated accountant who espouses less government. I believe that our tax dollars are well spent by the addition of new reviewers at the CDRH. What do you think?