By Mark Land, AAHP president
September 1, 2017
I took a course several years ago titled Regulatory Intelligence. The first thing the professor said was, “This course is not designed to teach you how to spy on your competitors.” Then she gave us links to 15 news feeds from the U.S. Food and Drug Administration (FDA). Since then, I have read these 15 and maybe five or more others each day. It can drive you nuts. Then I found a feed from FDA called “Updates for Health Professionals.” The health professionals feed is published on Thursdays and summarizes the week’s news. If you have limited time, read the health professionals feed.
In the bigger picture at FDA, the President has nominated and confirmed Tom Price as Secretary of Health and Human Services and Scott Gottlieb as Commissioner of Food and Drugs. While I find Tom Price largely the political face of public health, Scott Gottlieb is another matter. Dr. Gottlieb has a history with FDA, serving as Acting Commissioner earlier in his career. He understands what is necessary to get things done there.
I recently heard Commissioner Gottlieb speak about his agenda at FDA. In short, he wants to advance the administration’s agenda at FDA but just not in the same way that President Trump has proclaimed. It is not practical to think we can just lay off a bunch of career FDAers and close the budget gap. Commissioner Gottlieb explains that it is a matter of reorganizing, reducing protectionism on the part of big pharma, and rewarding organizations and individuals for innovative health care products.
Gottlieb went on to mention that FDA must be willing to take some risks when it comes to certain medical devices, including wearable personal diagnostic and information-gathering devices like Fitbits, etc. What this means in practice is something similar to the OTC monograph system for low-risk devices. Reviewing by category rather than individual submissions means faster output for FDA and speeding up delivery of innovative products to users. In summary, Commissioner Gottlieb is all about working smarter, not more expensively.
Get in-the-know by customizing your news feed from FDA here.