Old-Fashioned Regulatory Approach Simply Isn’t Working for Modern Combo Products
Mark Mansour, Partner, Bryan Cave, LLP
FDA and Congress have launched a full court press to address the issue of food, drug and device safety (the food safety bill is moving as we speak). We have seen this past week a flurry of letters, articles and pronouncements about the need for enhanced safety measures for devices.
No one, certainly no one among the responsible industry community, can criticize the objective. At the same time, anyone who understands FDA and the system we have will tell you without hesitation that one of the casualties of the full court press toward safety will be any hope of a short or even medium term solution to the steadily worsening delays in approvals. While this issue plagues all sectors of the pre-market process at FDA, one can make a reasonable argument that the worst potential issue is the logjam at the Office of Combination Products.
As readers well know, combination (or “combo”) products are combinations of FDA regulated products (drugs, devices, biologics). FDA established the Office of Combination Products to streamline approvals. What has happened is that the office — understaffed, under funded and now under its third or fourth head — is hopelessly behind.
Meanwhile, new products clog the pipeline, many of which are nanoscale therapies and other emerging technologies that have inestimable life-saving potential. They are unlikely ever to see the light of day absent some commitment by Congress and the Agency to ensure not only that the Agency can do its enforcement work, but its equally important work approving new, innovative products that have the potential to change lives. The office handles applications passably well in that they make it into the pipeline. Where they go, how manufacturers interact with agency officials and most important, the development of clear, predictable policies for pathway management and conduct of clinical trials is virtually non-existent.
Absent predictability, communication and timely consideration, manufacturers will shy away from wasting good money (especially in these times) letting their intellectual property sit for indeterminate periods in a regulatory and public policy black hole. There is, indeed, a growing perception (accurate or not, it is out there) that manufacturers and government work more effectively in the EU toward approval of safer, innovative products, and they do it faster and at less expense.
The worsening delays and administrative confusion that characterizes the regulation of combination products is a microcosm of a much-broader problem. All of the attention focused on safety is to be expected and lauded. That said, the problem is much bigger than anyone seems willing to admit. The hearings and proposals before Congress today are band-aids. The real problem is a regulatory system that is designed to address mid-20th century technology, designed for the benefit of a population that was much smaller, in an era during which innovations such as we see today were unthinkable. The system has been patched over, amended, buffed, clear coated, stripped and polished. That was fine for a while.
The world in which we live, however, demands something much more sophisticated, better funded and more robustly staffed than the one we have today. And although no one ever is inclined to discuss it, everybody privately agrees that no thinking person would today design the regulatory system with which we live. It is an artifact, and the sooner all stakeholders sit down and think through what a replacement should look like, the better. If we are to engineer health reform, we might want to think about reforming the regulatory system that oversees the products that constitute the nucleus of that system.
Now that would be real change.
