Trump’s pick for FDA chief causes concern

Jim O’Neill, a Silicon Valley investor who has advocated a radical reduction in FDA regulations, could be in line to take charge of the agency.

While the rumours haven’t yet been confirmed that the president-elect will put O’Neill forward for the role, numerous media reports have named him as being in the frame to be Commissioner of the FDA.

O’Neill is a managing director at Mithril Capital Management, and served in government as part of  the George W. Bush administration as principal associate deputy secretary at the Department of Health and Human Services (HHS).

Like so many of Donald Trump’s nominees for other senior government appointments, O’Neill would represent a huge break from convention, being relatively inexperienced in healthcare and, unlike previous FDA Commissioners, not a trained physician.

A speech O’Neill gave on the FDA and funding transformative innovation in 2014 has generated the greatest level of concern – as O’Neill expressed distrust in regulations and medical experts at the agency.

“As a libertarian, I was inclined to believe that the regulatory costs that the FDA impose kill a lot of people and provide a lot of harm to the economy, and I don’t deny that … but one thing that surprised me is that the actual human beings at the Food and Drug Administration like science; they like curing disease and they actually like approving drugs and devices and biologics.”

He also criticised the structure of the regulatory system, for  instance calling the FDA’s accountability to Congress “a miserable process”.

O’Neill said at his time at the HHS he had moved to block the FDA over-extending its regulatory reach, specifically in relation to the agency’s wish to scrutinise 23andMe’s consumer gene tests.

Nevertheless, the basic principles O’Neill set out have much in common with other efforts to accelerate approval in the US and Europe. He calls his approach ‘progressive approval’ – similar to the conditional approval systems now operating in the US and Europe.

O’Neill also name-checked the work of the UK-based Centre for the Advancement of Sustainable Medical Innovation (CASMI), which aims to develop new models of medical innovation.

O’Neill is currently employed by Silicon Valley billionaire Peter Theil, who is advising Trump on his administration appointments, and is understood to be pushing for O’Neill to be nominated for the FDA role.

The extent of O’Neill libertarianism is demonstrated most colourfully in his involvement in the Seasteading Institute, a Thiel-backed venture to create new societies at sea, away from existing governments.

Plans still undefined

The Trump plan for the FDA remains undefined. The website of his transition team merely stating that it aims to “reform the Food and Drug Administration, to put greater focus on the need of patients for new and innovative medical products” and advance healthcare research  efforts.

Shares in pharma and biotech rallied on the news of Trump’s election victory on 9 November, as investors were relieved that Hillary Clinton’s promised attack on pharma prices had been averted. However Trump has himself now declared that tackling drug prices is one of his aims.

Time magazine named Trump as its Person of the Year this week – not necessarily an endorsement – and in his interview with the magazine, the president-elect vowed to “bring down drug prices”.

However pharma and biotech companies have also expressed reservations about a weakening in the FDA’s regulatory oversight, as many believe this allows investment in the best science to win out over weaker R&D.

This week also saw the passing of the 21st Century Cures Act, which aims to further accelerate approval times, and loosen some of the demands on efficacy for experimental treatments.

The legislation has been supported by US industry bodies such as PhRMA and BIO, but many industry and FDA insiders have expressed concern about the changes, which they fear could result in ineffective or even unsafe medicines gaining approval.

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