CONDITIONAL APPROVAL BILL INTRODUCED TO US HOUSE AND SENATE

CONDITIONAL APPROVAL BILL INTRODUCED TO US HOUSE AND SENATE. Plan would dramatically reduce drug costs and time to market.

US Rep. Bruce Westerman and US Sen. Mike Braun have introduced legislation that would create an accelerated pathway for drug approval similar to systems adopted by Japan and China. While Japan and China allow sale of drugs for critical needs after a phase 1 trial, the Westerman/Braun bill requires a phase 1 and phase 2 trial, at which point the drug could be sold but require some collection of data for a post-sales phase 3.

I don’t know what the odds of passage are but I assume that this bill will be opposed by the enormous pharma-industrial complex that profits from the current regulatory system. Nevertheless, everything is proceeding as I have foreseen.

The demographic crisis of increasingly older and sicker populations combined with plummeting birth rates is already creating enormous economic problems in Asia. National debts are driven mostly by the need to borrow to pay for the cost of the aged.

Though less obvious in the US and Canada, the same forces are at work in the West, and will soon overcome the ability of the status quo to resist major change. The Big Question, of course, is whether it will happen soon enough to benefit older people who are on the cusp between 1.) suffering and dying of age-related diseases and 2.) benefiting from the anti-aging therapies in labs.

South Korea will probably implement conditional approval soon, making breakthrough drugs currently languishing in regulatory hell available sooner and more cheaply to an aged population that is now denied powerful regenerative therapies. My guess is that Canada will follow suit before the US, but that could change. One reason for my optimism is evident in the popularity of Right to Try (RtT) movement and law in the US.

RtT enjoyed massive popular support and was implemented despite serious opposition by big pharma. RtT gives patients with terminal conditions the right to use drugs that have gone through phase 1 safety trials but it does so on a case-by-case basis. This means that the costs are too high to allow mainstream RtT usage. The Westerman/Braun legislation would fix that problem, though it would require phase 2 data showing promise of effectiveness.

(Helpful reminder: You have a terminal condition even if the symptoms aren’t yet manifest.)

Why wouldn’t big pharma want conditional approval? Essentially, it is because startup biotechs can afford to run phase 2 trials. In most cases, however, startups are forced to give up most of the profits from their drug candidates to big pharma companies that have the resources to run phase 3s. The justification for this system is that it increases safety and reduces the sale of drugs that don’t work. This is true but it should be measured against the suffering and death caused by denying or delaying access to therapies in development.

Here’s Westerman’s editorial supporting the bill in The Hill.

Note. Another reason for my optimism is that there is increasing evidence that biological age can be at least temporarily reversed, allowing longer healthspans, the amount of time that we spend in a healthy non-diseased state. The best recent example is the Fahy human growth hormone trial.