Something huge is going to be happening soon at the U.S. Food and Drug Administration (FDA). There’s lot’s of chatter about it. From a “Coming Political Hurricane” to a “Libertarian Take-over,” it is all anticipation about the transition of government.
Most of it seems to be directed at drug approvals and medical devices, not food. Many weeks ago, the Trump campaign did post a “food police” page on its website that was apparently some type of food freedom creed, but it was quickly taken down.
The chatter about drugs and medical devices is increasing, not going away. In fact, it will likely increase this week as FDA Commissioner Dr. Robert Califf steps down and is temporarily replaced by Dr. Stephen Ostroff , who last June replaced Mike Taylor as deputy commissioner for food and veterinary medicine. He now fills in as acting commissioner.
That Dr. Califf, one of the nation’s most renown cardiologists, won’t see his first anniversary as FDA Commissioner, when he was willing to continue, shows just how much FDA is changing. FDA has long been led by reknown scientists and medical doctors. All those degrees are not going to mean as much.
That’s because the only prospective candidates for FDA Commissioner are from the world of venture capital, a sector that plays a big role in drug development. Trump is said to be looking for new thinking to change government from Silicon Valley billionaire Peter Thiel. He’s been calling for bold action.
Thiel owns Mithril Capital Management, where Jim O’Neill is managing director and an apparent candidate for FDA Commissioner.
Another is Balaji Srinivasan, a partner in the venture capital firm Andreessen Horowitz. Both met with Trump as recently as last week. A third possibility is former FDA deputy commissioner Dr. Scott Gottlieb, now a resident fellow at the American Enterprise Institute.
Where this may be going is a “Back to the Future’ move. Dr. Andrew von Eschenbach, President George W. Bush’s second FDA Commissioner, came up with the progressive system to speed drug approvals. It eliminates the costly stage 2 and 3 drug trials that often require promising drugs to be sold before they are approved. Progressive approvals are used for some drugs in japan, but the idea was killed here by Big Pharma.
There are several steps that must occur before any of this plays out. First, the Senate will have to complete action on Rep. Tom Price’s confirmation as Secretary of Health and Human Services. Next, Trump will have to nominate the next FDA Commissioner, who will then be subjected to the kind of examination that the cabinet appointments have gone through. How the Senators feel about quicker approvals is certain to be tested. Are they going to be faster approvals, which are popular with some patients, or are they going to remain in the comfort of Big Pharm.’s pocket? Oh yes, it will get played with such harsh portrayals.
Only after the new FDA Commissioner takes command will the ponderous process of any changes actually begin. Until then, there’s sure to be more speculation. The likelihood is that any turmoil that lies ahead for FDA won’t have food at the front and center.
It should instead be able to get about using the Food Safety Modernization Act, preventing foodborne illnesses, and ignoring the noise that may be coming from other parts of the agency.