Thursday, December 8, 2016

Why Donald Trump's Putative FDA Pick Could Scare Pharma


Forbes Staff 

Yesterday, Bloomberg reported that Donald Trump is considering nominating venture capitalist and libertarian Jim O’Neill to head the Food and Drug Administration, and some in the pharmaceutical industry experienced an increasingly strong sense of nausea.

O’Neill, works at Mithril Capital, the firm founded by Paypal and Facebook backer Peter Thiel. That alone could normally serve to generate concerns about conflicts of interest with medical firms he helped to found. But O'Neill has also argued in the past that the lack of a functioning free market is the central fact that makes the current U.S. medical system overly expensive and wasteful. At a conference about creating new societies on ocean-rigged platforms, he argued that a better system would not involve government protections, that people should be able to pay others for organs used in transplants, and that the current system encourages bad health. “In a free market, you wouldn’t be forced to subsidize obesity,” he said in 2009.

But the quote that is causing the most unease is one about one of the FDA’s core missions: regulating drugs. In an August 2014 keynote at the Rejuvenation Biotechnology conference, O’Neill suggested: “We should reform FDA so there is approving drugs after their sponsors have demonstrated safety--and let people start using them, at their own risk, but not much risk of safety. Let’s prove efficacy after they’ve been legalized.

Former FDA Commissioner Charged In RICO Lawsuit

That quote betrays a lack of understanding of how drug approvals actually work, or a commitment to rolling back the clock 50 years.

Most drugs are not safe. Instead, their benefits outweigh their risks. For instance, Iclusig, a drug used to treat a type of blood cancer, causes blockages in veins and arteries that can be deadly. But it is approved because the benefit, for cancer patients who have been failed by other drugs, is big enough that risk is worth taking.

Continue Reading.

Thank You Mr Herper and Forbes. 

Most Drugs Are Not Safe?

Most Psychiatric Drugs Are Not Even Legal.
(there, fixed it for you)

US 18C95 Sec 1958: Murder For Hire  

Many biotech entrepreneurs are actually fans of a tough FDA. At the Forbes Healthcare Summit, pharmaceutical billionaire Leonard Schleifer, the founder and chief executive of Regeneron Pharmaceuticals, said that he was against “making it really easy to get your drug approved” at the Forbes Healthcare Summit last week, before news of that O’Neill was under consideration leaked.

Schleifer said that he couldn’t compete with companies like Pfizer or Eli Lilly, which have 10 to 100 times as many salespeople as Regeneron. But he can compete to get approved first, or to have a better drug that has more uses that the FDA allows it to advertise based on science.

“Having a high bar is a good thing, in my opinion, because it allows innovators to compete,” (???) Schleifer said.

PDUFA User Fee Archive

Hell of a ticket price to get into the Compete.

And one hell of an incentive to FDA to ALLOW unsafe, clinical trial rigged drugs to get and stay on the market.

Congressional Research Service: The Food And Drug Administration (FDA) Budget: Fact Sheet July 28, 2016

FDA Wants More Money, Claims They Are A 'Bargain'.

Crony Capitalism?

PDUFA must go.

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