Wednesday, December 23, 2015

Another stupid political idea

I am fed up with all the presidential candidates already. I have no comment on many of the ideas they have raised, except for one.

Ted Cruz has decided that the FDA moves too slowly and proposes that if the FDA can't approve a drug fast enough, that Congress should step in and make the decision.

"The presidential aspirant from Texas, along with fellow Republican Senator Mike Lee of Utah, recently introduced a bill called the RESULT Act that would drastically overhaul the process for approving drugs and medical devices.

Under the proposed law, the FDA would have to approve “life-saving” products for which is there an unmet medical need if those drugs or devices have already been endorsed in “trusted, developed countries,” including European Union member states, Canada, Israel, Australia, and Japan. The agency would have only 30 days to make a decision. And Congress could override an FDA rejection with a majority vote." 

What do politicians know about safety and efficacy of medications? Nothing. And just because a drug has been approved for use overseas, doesn't mean it should automatically be approved here.

"If the bill becomes law, Americans will likely find themselves treated with medical products that were approved with varying, and quite possibly, lower standards elsewhere. In effect, his legislation stands to jeopardize — not improve — public health."
I agree with the principle here that the FDA moves slowly. But it is to our benefit that they do not rush to make decisions on drugs that could kill or cure you. We don't want decisions made fast. We want decisions made correctly, not politically or financially.

"To be sure, the FDA review process is not perfect. What is? But the agency is still considered the gold standard by which other regulators are measured. Rubberstamping an approval that was made in, say, Japan or Romania may speed access, but may not always ensure a medicine is safe or effective. Americans may want to ask themselves if they want to rely on regulators in other countries."

If the FDA moves too slowly, perhaps they should read more funding so they can have more staff and make decisions faster.

"Another problem with the bill is that the FDA would likely be hard-pressed to make decisions in 30 days. Given its workload, the agency would need more money to meet such a goal. Right now, companies pay fees to help cover review costs. Would industry pay higher fees? Would Congress appropriate more funds to cover shortfalls? Is it realistic to think an FDA review can be comprehensive that quickly?"

Think about it this way. We would then be putting our faith in drug approvals systems which are completely beyond our control. Congress would simply being agreeing with a process of which they know nothing.

"Perhaps the most troubling provision in the legislation is the notion that Congress should be permitted to override any FDA decision not to approve a product. Such a move would politicize the review process, especially as more patients and their families clamor for new treatments.

“You can just imagine the first time that Congress overrides an FDA decision and there are bodies in the street because of it,” said Robert Pollock, a former senior FDA official, who is now a senior advisor at Lachman Consultants. “It simply doesn’t make sense. Congress is not trained to do that work."

Okay, I'm done complaining on this, for now.

1 comment: said...

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