Jim O'Neill

I've caught a fair amount of flak over my opposition to so-called "right-to-try" laws. Right-to-try laws have proliferated throughout the US like so much kudzu over the last three and a half years, to the point where 37 states now have some version of these profoundly anti-patient laws on the books. At the federal level, three weeks ago the Senate passed a federal version of right-to-try, with the House scheduled to take up the bill when Congress returns from recess next week. Granted, it's watered down and therefore less horrible than the original version, which Senator Ron Johnson (R-WI_…

There is a belief that is very prevalent among policymakers right now, particularly Republican policymakers, that the key impediment to drug development is the Food and Drug Administration. According to this narrative, the FDA is an overly strict, overly bureaucratic, and rigid organization that is the main barrier keeping fantastic cures to all sorts of deadly and debilitating diseases from flowing to the people at a reasonable price. The basic idea, as I've discussed many times, is that, if only the FDA would get out of the way, universities and pharma would be free to open the floodgates…

I’ve seen it noted that our new President-Elect seems to be selecting his cabinet officers and directors of federal bureaucracies based on how much they oppose the mission of the department they are supposed to head. For instance, to head the Department of Health and Human Services, he picked an orthopedic surgeon who belongs to an organization utterly opposed to any role of the federal government in health care and who himself looks poised to dismantle as much of the Affordable Care Act as he can. For the Department of Energy, he picked Rick Perry, a man so dumb that when he was asked during…

Yesterday, I noted the passage of the 21st Century Cures Act, a Hobson’s choice of a bill for those of us who support increased biomedical research funding that basically said: You can have an increase in the NIH budget. You can have the Cancer Moonshot. You can have President Obama’s Precision Medicine Initiative and his brain mapping initiative. You can have additional funding to combat the opioid crisis. You can have all that, but only if you also accept a grab bag of longstanding pharmaceutical industry wishes, such as new pathways to approve drugs and devices with a lower standard of…