FDA: Between a rock and hard place

Oct/30/2007 06:09 Filed in: In The News
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It's not easy working for the FDA these days. Every time there is a new reported issue with a drug or medical device some congressman gets on his soap box and wants to know what the FDA knew and why they approved the product. The latest example is the lead in heart defibrillators produced by Medtronic. Although medical devices don't go through the same scrutiny as drugs congress wants to know who, what, when and where. If the FDA is indeed charged with the oversight of all medical products, including drugs and medical devices then Congress had better increase the agencies budget so that they can hire a LOT of people.



Combine science and politics and you have a recipe for disaster. The FDA is being asked to do more and more and yet their staffing levels are not adequate to do the job they need to do now. DDMAC is understaffed and still does not know how to tackle Internet advertising, search engines and product websites. Is it advertising or consumer education? Does fair balance need to accompany key words on Google?


Now in a page 1 story in today's Wall Street Journal some people in congress want to know how the FDA approved Medtronic's heart defibrillator and the leads that have recently been recalled. First let me state that this author works for Medtronic in the diabetes product category, but as I read the story in today's paper I was taken back by the alleged chain of events so let me ask the audience a hypothetical question: if a product, medical device or pharmaceutical, receives reports of problems should they immediately stop selling the product or gather data to determine the extent of the problem? This is where science meets politics. The scientific approach would be to collect data to determine the who, what, where and how and then recommend an action based upon the data. The political approach of course would be to "cease and diciest" from all sales immediately regardless of the impact on patients health.


So rather than work with the FDA and pharma and medical device companies those in congress choose to grab headlines and point fingers. Great for reelection but hardly a method for fixing a broken system. If the FDA is going to be scrutinized on everything they have approved then resources are going to be spent on past data instead of new data on existing drugs and those who have filed NDA's. Above all the FDA is going to need a budget increase to hire people so that resources can be allocated as needed to get new products to market and monitor those already on the market. Another issue, however, is how many people would want to work for a government agency? Scientists and medical professionals often get frustrated working in a government agency and frankly most could make more, a lot more in fact, working in the private sector.


We have come to a point in American politics where it is better to point fingers and pitch for headlines rather than give an agency the resources it truly needs to do a job that entails patient trust in new products. That's too bad, once again politics has taken center stage while patient safety awaits in the wings.
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