There are few jobs more important to keeping us safe and healthy than the commissioner of the Food and Drug Administration.
This is why I was really excited to learn that President Obama nominated Dr. Robert Califf as commissioner of the FDA.
Indeed, Dr. Robert Califf is a name you probably haven’t heard, unless your background is in clinical cardiology, academia or if you’ve kept your ear very low to the ground inside the Beltway.
And yet, the job he’s been nominated for is an absolutely crucial one for our nation’s health. And by health, I don’t just mean protection from Mexican cucumbers with Salmonella Poona (which, as an aside, happens to be a very pressing issue). I mean the long-term health of everyone in my (and your) family.
Our health as a nation (for future generations) is at stake, and Dr. Califf is who we need to ensure that medical discovery, product and device approval and safety surveillance is held to the high standards of a first-world country (as America purports to be). We want a guy who knows what he’s doing, and we get that in Dr. Califf.
Before joining the FDA in March 2015, Dr. Califf ran the Duke Clinical Research Institute — accepted as the largest and most substantial clinical trial center in the nation. Before that, he was a cardiologist with an interest in clinical research. He understands the industries he needs to regulate because he has worked closely with them, and more importantly, he understands the people his agency is charged with protecting: us patients.
I got to know Dr. Califf in early 2014, when I became a co-principal investigator of the CreakyJoints Patient Powered Research Network Arthritis Power. Dr. Califf was co-chair of the PCORnet Clinical Trials Task Force and, by default, mentor to those new to patient-centered research and trials.
It is through those PCORI interactions I witnessed first-hand his longstanding commitment to patient-centered research and his passion for helping others. With Dr. Califf leading the FDA, patients can be confident that their voices will be heard, and as importantly, patient-centered interests will be incorporated into the regulatory process.
Regulation of our health care universe is a blessing and a curse. Sure, the FDA has lots of red tape ( read a single guidance document, and you’ll understand the meaning of red tape), but it’s there for a very good reason: to protect us! Companies — and their zealous investors and sometimes reckless management or leadership — can’t be trusted to self-regulate. Examples of when companies went afoul of their responsibility in health care are way too numerous to list. I’ll spare you some of the horrifying specifics or the text of the many corporate integrity agreements signed with various federal agencies, including the Justice Department and Health and Human Services — by some of the largest and best known companies in healthcare. But any astute observer of history knows that for all the nay-saying and rhetorical abuse that government regulation takes, the result of it is for our collective benefit.
The FDA is turning a corner and evolving to meet the changing needs of our 21st century society while balancing those of the free market economy, industry, academia and the public. Subjects likely to hit Dr. Califf’s desk, and that of his agency, include fixes to an ailing clinical trial and device approval system, the proliferation and regulation of electronic cigarettes, the amazingly complicated subject of cannabis (medical marijuana) and successfully integrating health technology and data into our lives, just to name a few.
Dr. Califf at the helm of this agency ensures that sensibility, responsibility and patient-centricity will remain a priority when dealing with these and other issues.
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Why Robert Califf Deserves to be FDA Commissioner originally appeared on usnews.com