Ted Cruz Will Cure What Ails You. Or Not.

The Senator from Texas wants pharmaceutical companies and foreign governments to make your health decisions for you.

By Jim Knipfel

 

It may not have received the press coverage some of his other, more flashy (i.e. “insane and terrifying”) campaign proposals have, but Ted Cruz’ planned modifications to the FDA’s drug approval process are no less, well, insane and terrifying.

 

As is to be expected, Cruz put the happy populist face on his new proposal, pitching it to the sheep as a way of allowing Americans to get their hands on new life-saving drugs faster and easier, without having to worry about all that inevitable and ponderous FDA red tape. What it boils down to is this: if a new drug or medical device has been approved by some Western-friendly nation (Australia, Israel, Canada, Japan, or the EU), the FDA will then have 30 days to approve or deny it for use in the US once an application has been submitted. Should the FDA reject the drug, Congress would then have the right to step in and overrule that decision in order to make the drug available to anyone who wants it, no matter what those egghead scientists at the FDA say.

 

Okay, then. There’s no denying the FDA could use a spit shine, but let’s think about this one for a minute.

 

Given that Big Pharma always has the well-being of their customers in mind first and foremost when it comes to the safety of any newly-developed drug, they would never ever consider skipping around those hardasses at the FDA to instead initially submit a drug to a friendly foreign nation with a much more relaxed approval process. I mean, the very thought of doing whatever was necessary just to get the damn thing on the market anywhere, hoping to slip it into the States through the back door would be not only unethical, but patently absurd!

 

Despite having received over $100,000 in campaign contributions from pharmaceutical companies, Senator, and potentially President Cruz would never think of allowing that to influence his decision to shove a new drug through Congress to help out his friends, as that too would never be something any elected official would dream of doing.

 

Given the deep and complex working knowledge of scientific and medical issues exhibited time and again by our elected officials as they’ve debated climate change, stem cell research, evolution, and the like, they certainly have an equal if not better understanding of the intricacies of drug safety than the biochemists and medical researchers working for the FDA, In short, they would be  perfectly well-equipped to make reasoned and rational decisions on such matters (and much more efficiently than the agency’s scientists) after carefully considering all the presented data.

 

And even though in recent years the FDA has been approving more drugs more quickly than ever, it’s just best to have a backup plan, right? I mean, what if they reject a new drug a major pharmaceutical company really, really wants to get out on that lucrative US market? What, you’re gonna let a bunch of nervous Nellie scientists stand in the way of the US economy? So it’s all sounding pretty good so far,

 

But as pointed out by bioethicist Lisa Kearns in a recent piece in The Hill, in the 1950s the German-manufactured drug Thalidomide received quick approval for use in Western Europe as an anti-nausea medication for pregnant women and was widely prescribed, especially in Germany and England. In the States, however, that persnickety stick-in-the-mud the FDA, after a great deal of testing and research, concluded Thalidomide could likely result in serious birth defects and rejected the application. Can you imagine that? With

 

But we’ll just ignore that little insignificant blob of an historical glitch. I mean, we’re talking $100,000 in campaign contributions, here!

 

Published December 24th, 2015


Jim Knipfel is the author of Slackjaw, The Blow-Off, These Children Who Come at You With Knives, and several other books.