A Tough Balancing Act for the FDA

Yesterday, The Wall St. Journal published an op-ed piece by the commissioner of the Food and Drug Administration Margaret Hamburg. As to be expected, it was an apologia for the beleaguered federal agency. It should come as no surprise that it was published in the Wall St. Journal rather than the NY Times. However, to be fair, the Journal has been balanced in its reporting of FDA shortcomings and controversies, especially concerning their 510(k) approval process for medical devices.
Commissioner Hamburg does not have an easy task in overseeing the FDA. On one hand, it’s critical for an appropriately expedient approval of drugs that benefit the consumer and may save lives. On the other hand, patient safety requires exacting scientific standards that are often at odds with the marketing and business plans of the large pharmaceutical and medical device companies. Of course, it would be tremendously helpful to the FDA if all pharmaceutical and medical device companies considered safety issues as vital to their own bottom line as the profits made from the sale of these products. There exists an inherent tension and at times, a conflict of interest within these companies. That tension and/or conflict exists between the scientific research divisions and the marketing divisions. Unfortunately, in some instances the marketing division influences and dominates the research. In these cases, it falls to the FDA to step in and ensure patient safety. Perhaps the best and most recent example of such tension can be found in the marketing and sale of the metal-on-metal hip replacements, some of which have failed-the DePuy ASR XL and DePuy Pinnacle hips are the most obvious instances of this. In light of this, the FDA has intervened and called for a thorough review of these metal-on-metal hip replacement devices. For some patients who’ve already suffered through revision surgeries, FDA action has come too late.