When Trump Comes to FDA

(Analysis by Jim Dickinson) When President-elect Donald Trump turns his attention to FDA, he’ll likely face his comeuppance. As guardian of one-quarter of the Gross National Product, FDA is the agency closest to the daily wellbeing of the entire U.S. population (and indirectly to that of millions of others worldwide who unknowingly shelter under its scientific and regulatory aura). Such an agency is not to be trifled, which is not to suggest that it should be totally immune to a White House change-maker.

Trump’s first official awareness of FDA is likely to come from his selection for HHS secretary, six-term Atlanta-based congressman and orthopedic surgeon Tom Price, 62, who has displayed little interest in the agency other than to unsuccessfully vote against it being given regulatory control over tobacco products. Price’s first order of business will be to vanquish his primary target as a congressman ꟷ the Affordable Care Act, an objective that has the full backing of Trump as well as Price’s own conservative medical colleagues.

Second on Price’s agenda will likely be implementing the 21st Century Cures Act, which is more focused on such HHS agencies as NIH, CDC and the Centers for Medicare and Medicaid Services than on FDA. They, at least, have more claim on his attention as sources of fiscal profligacy than has FDA. Although Price was among the 392-26 majority that voted for the final version of the Cures act in the House, he voted against its first iteration in 2015, complaining that it set “an unacceptable precedent – particularly at a time when so much of our federal budget is already on auto-pilot, increasingly difficult to control and a significant risk to America’s fiscal well-being.”

Although his record says he is more attuned to economics than to medical product innovation and regulation, HHS’s implementation of this legislation will force some awareness of FDA on Price because of its provisions affecting reviews of new devices, drugs and combination products. His choice for the next FDA commissioner will be key to such programmatic and budgetary adaptations ꟷ and to gaining the acquiescence and support of FDA’s several House and Senate oversight committees.

Who might such a pick be? All prior commissioners for more than 50 years have had medical backgrounds, and as a medico himself Price might be expected to follow in that tradition. However, in December, Bloomberg News reported that Silicon Valley investor Jim O’Neil, managing director of one of billionaire Peter Thiel’s venture capital firms, was being considered by the Trump transition team to lead the agency. O’Neil, who previously served at HHS under President George W. Bush, has about as much medical background as Trump’s Secretary of State choice, Rex Tillerson, has government background ꟷ which is to say, none.

O’Neil has advocated for new radical approaches in allowing products on the market, Bloomberg noted. In a 2014 speech, he supported reforming FDA approval rules so that drugs could be given a “progressive approval,” where they are allowed on the market after demonstrating safety. “Let’s prove efficacy after they’ve been legalized,” he said at a conference called Rejuvenation Biotechnology.

In the speech, Bloomberg reported, O’Neill said that while he was at HHS he opposed FDA’s regulation of direct-to-consumer genomic testing services such as 23andMe. “In order to regulate in this space, FDA had to argue that an algorithm, a series of numbers that match up to things, is a medical device,” he said.

O’Neil was quoted by Bloomberg as saying, “I found that really astonishing — astonishing that someone could say it with a straight face, and astonishing that someone could claim the ability to shut down companies that were never touching a patient but only accurately matching algorithms.”

On12/23, the Wall Street Journal reported that Price has traded in drug company stocks while in Congress and sponsored legislation that benefits the companies. His stock trades His stock trades included Amgen Inc., Bristol Meyers Squibb Co., Eli Lilly & Co., Pfizer Inc. and Aetna Inc., the Journal reported, adding that these are expected to be a focus of his confirmation hearings.

All this might fit in very well with Trump’s famous departures from convention, strongly evident in his cabinet choices. Although he has been inconsistent in applying his campaign rhetoric about “draining the swap,” nominating somebody like O’Neill could signal an attempt to bring about major structural change at FDA.

That would be much easier said than done. The FDA foot soldier’s historic but rarely uttered philosophy, most recently alluded to by CDER director Janet Woodcock, has been as one such trooper, the late Rudy Apodaca, put it during the Reagan transition: “Commissioners come and commissioners go, but we are always here.” Although she recently survived an unprecedented lower-ranks “science first” revolt in the eteplirsen approval uproar ꟷ evidence that bureaucratic resistance is permanent and deep, Woodcock’s version of this is “business as usual” ꟷ notwithstanding the transition.

Which is as should be. FDA’s mission is non-political, although some Administrations have thought otherwise, and have even been surreptitiously successful ꟷ as George W. Bush’s was in suppressing for a time the approval of the Plan B “morning after” pill for unrestricted over-the-counter sale. Since then, there have been other less-famous attempts at politics trumping (pun intended) science at FDA, the Menaflex device clearance and opioid approvals.

This syndrome, although still rare, began after Ronald Reagan’s 1980 landslide, which was accompanied by bellicose comments from his K Street supporters. I remember walking in on apolitical deputy commissioner Mark Novitch the morning after, as he stood staring glumly out his window across the dying treetops below. Half to himself, he muttered, “I just hope they don’t tear down everything we’ve built.”

They didn’t. It takes more than a same-party lock on both chambers of congress for any White House to make law and appointments stick. They have to be persuasive to the various majorities both on and off Capitol Hill.

For all its faults and limitations, a procedurally creaky FDA has shown a remarkable ability to survive all administrations and congresses, basically intact. Commissioners come and commissioners go, but down in the trenches, FDA’s essential work goes on, basically intact and unreachable by its political masters.