Possible FDA Commissioner O’Neill: Return Medical Decisions to Patients and Doctors

President-elect Donald Trump may nominate Jim O’Neill as commissioner of the Food and Drug Administration. O’Neill, who has already worked to oversee FDA as principal associate deputy secretary for the department of Health and Human Services (making him third-in-charge at the $700 billion department), has been working as a health care investor at a Silicon Valley venture fund since leaving the federal government.

O’Neill has been receiving flak for a 2014 speech at the SENS Research Foundation’s Rejuvenation Biotechnology conference, in which he suggested that FDA should approve drugs once they pass phase II, or safety, trials. This would mean that patients could access drugs that they and their doctors think may work for them, with peace of mind thanks to FDA’s safety stamp (which, it should be noted, is something FDA already does).

While this idea, known as progressive or conditional approval, has struck pundits as excessively radical, it seems to be what both regulators at FDA and pharma insiders actually want. No less than former FDA commissioner Andrew von Eschenbach has argued that “after proof of concept and safety testing, the [new therapeutic] product could be approved for marketing with every eligible patient entered in a registry so the company and the FDA can establish efficacy through post-market studies.

FDA has long been criticized both for taking too long to approve drugs as well as refusing to approve drugs that other country’s regulatory bodies have already approved. For example, by FDA’s own numbers, perhaps 100,000 people died unnecessarily because FDA spent years saying that beta blockers, which had been approved in Europe, were too cardiotoxic for Americans.

If O’Neill is nominated and confirmed, doctors will have more leeway to prescribe drugs that they and their patients might want, from seemingly pedestrian ones such as sunscreens that actually work (according to European regulators) to personalized drugs designed for a specific genotype (FDA doesn’t know how to prove the efficacy of a drug that may only work on one person) to drugs with unclear markers of efficacy (such as drugs that may extend the health- or lifespan, another area FDA hasn’t figured out how to regulate).

However uncertain the future seems to be in light of the upcoming Trump administration with its array of drug warriors (such as the radically anti-marijuana attorney general nominee Jeff Sessions), patients as well as opponents of the war on drugs more generally should take heart from and support the nomination of Jim O’Neill for FDA commissioner.

No comments yet.

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s

%d bloggers like this: