Right-to-try law as stealth deregulation

[Isgrimnur]

Science Based Medicine

[T]he very concept behind right-to-try is designed not to help patients, but to give the appearance of helping terminally ill patients as it serves as the first step in cutting the FDA out of drug approval and regulation as much as possible. Consider: these laws, being state laws, have no teeth because drug approval is under federal jurisdiction. Sure, a state can say that patients have a right to experimental therapeutics, but unless the FDA agrees to say yes, no company with a drug in clinical trials for FDA approval is going to risk the wrath of the FDA by taking part in right-to-try.
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It’s much worse than that, however, because these laws are actively anti-patient, the claims of their supporters notwithstanding. The only requirements these laws have for testing of the drugs being “tried” are (1) that they have passed phase I clinical trials and (2) that they are still under development and undergoing further clinical trials. Anyone out there who is familiar with clinical trials knows that passing phase I is an incredibly low bar for safety. Phase I trials are “first in human” trials in which a small number of patients test the drug. Basically, the dose is escalated until unacceptable toxicity is encountered. The dose just below that is called the “maximum tolerated dose,” or MTD. The main purposes of phase I trials is thus to identify the highest dose that can be safely used and to identify the most severe adverse reactions and side effects. That’s it. Phase I trials are not designed to determine if a drug has any efficacy. Saying that a drug that’s passed phase I testing is safe, as I’ve heard many right-to-try advocates claim, is utter and complete bullshit. Phase I trials do not prove safety. They merely show that the drug is not too toxic to continue with efficacy testing.
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Another aspect of these bills is, as Jann Bellamy and I have described many times, how, compared to existing expanded access programs, they strip patient protections away from patients who access them. One way to see this is by comparing what happens when a patient accesses an experimental therapeutic under the FDA expanded access program to what happens when another patient accesses one under a right-to-try law. Under FDA expanded access, patients retain full protections under federal and state laws. They can sue for malpractice if there is any, and their care is still monitored by an institutional review board (IRB), with any adverse events recorded and considered by the FDA. Moreover, the FDA approves nearly all such requests (99%). In contrast, under right-to-try, there is no IRB oversight. It’s all between the company and the patient, a libertarian paradise!

The Trickett Wendler ... Right to Try Act has been on the president's desk since May 24th.

[Isgrimnur]

White House.gov

The FDA’s “compassionate use” application is complicated and time-consuming, resulting in only about 1,200 approved applications per year.

So rather than get them to fix the process or give them resources to fix it, they're just going to bypass it completely.

[LawBeefaroni]

White House.gov

The FDA’s “compassionate use” application is complicated and time-consuming, resulting in only about 1,200 approved applications per year.

So rather than get them to fix the process or give them resources to fix it, they're just going to bypass it completely.

The problem isn't that it's complicated and time consuming. The problem is that is hurts big pharma's bottom line. This is a way around FDA approval. Big money.