I'm no fan of Ted Cruz (quite the opposite in fact), but I'm in favor of the idea he puts forth in the RESULT Act.
If a drug or technology is approved by the regulating authorities in certain other developed counties, this act ensures that it is automatically approved for use in the USA.
Let’s Revive America’s Culture of Cures and Innovation
The FDA denies approval to cures for diseases because of decades-old research standards that don’t make sense for today’s science.
I'm not sure that is a good idea.
What happens if that countries system is corrupt?
That's why it's only certain other countries. Â It's not just a willy-nilly every body gets in list.
If this legislation had been law in 1960, thousands of US children would have been born without arms and legs, as they were in European countries that approved use of Thalidomide for pregnant women.
+Mark Bothwell and if it had been law since 1960 thousands-to-millions would have not died, or not gotten ill, or had better lives with access to drugs that the FDA had not yet approved.
I can prove that my statement is correct. You cannot prove that your statement is correct.
Speaking as someone who has worked as a  consultant for the FDA to evaluate new drugs, and also worked as a consultant for companies seeking to obtain approval of drugs by the FDA, it is my opinion that the FDA uses the best available science to strike the right balance weighing risk versus possible benefit. Hundreds of drugs that seem promising in early trials prove to be worthless in follow-up testing, and many promising drugs have horrendous and sometimes life-threatening side effects.
As usual, when Cruz talks about scientific issues, he goes seriously wrong. For example, he suggests that we should be approving drugs that affect "biomarkers" of a disease, without waiting to see if the drugs actually have a beneficial effect on patients with the disease. That, in a word, is ridiculous. That approach would lead to marketing of many worthless drugs because the link of biomarkers to a disease is invariably based on an unproven hypothesis. The reliability of any particular biomarker cannot be known until it is shown that drugs affecting the biomarker also affect the disease symptoms, so approving drugs shown to affect biomarkers but not disease symptoms is a stupid risky bet.
+Mark Bothwell ah, so it benefits your pocket! Of course it's clean!!!
+Mark Bothwell I wasn't endorsing the specific details of this law…thus my usage of the term "idea behind" and highlighting how I don't approve of Cruz.
That being said, while I cannot prove my statement, that is merely because I do not have the studies and information in front of me. Â It is not, as you imply, an unprovable statement.
Look at all drugs approved in other countries that are not approved at all, or as early as the FDA. Â Also look at the reverse…drugs approved by the FDA and not approved, or more slowly approved by other drug regulatory agencies.
Then look at the benefits of those drugs and the number of patients denied access to them.
Arguing against this idea is arguing for the idea that the world is better served by many organizations doing the same work at varying levels of efficiency. Â There is an argument to be made in that direction, but its certainly not a slam dunk.
Automatic approval makes little sense – but fast-tracking certainly does.