U.S. Passes 'Right to Try' Law Allowing Experimental Medical Treatments (chicagotribune.com)

schwit1 shared this article from the Washington Post: The House on Tuesday passed "right to try" legislation that would allow people with life-threatening illnesses to bypass the Food and Drug Administration to obtain experimental medications, ending a drawn-out battle over access to unapproved therapies. President Trump is expected to quickly sign the measure, which was praised by supporters as a lifeline for desperate patients but denounced by scores of medical and consumer groups as unnecessary and dangerous...

The FDA would be largely left out of the equation under the new legislation and would not oversee the right-to-try process. Drug manufacturers would have to report "adverse events" -- safety problems, including premature deaths -- only once a year. The agency also would be restricted in how it used such information when considering the experimental treatments for approval. Patients would be eligible for right-to-try if they had a "life-threatening illness" and had exhausted all available treatment options. The medication itself must have completed early-stage safety testing, called Phase 1 trials, and be in active development with the goal of FDA approval.
One Congressman opposing the bill argued that eliminating FDA oversight would "provide fly-by-night physicians and clinics the opportunity to peddle false hope and ineffective drugs to desperate patients," noting that the bill is opposed by over 100 patient advocacy and consumer groups.

Comments

Interesting balance

[raymorris]

This is a topic I've thought about before and I see two sides to it.

On the one hand, a person who is going to die of fatal illness should be allowed to try something that might save their life. "Proven safe and effective" is a good standard for headache medicine, but if you're almost certain die without it, "20% chance it might work" is worth a try.

On the other hand, we don't want people peddling snake oil taking advantage of desperate people.

The criteria in this law, fatal illness, a treatment that has already completed phase 1 trial, and is actively moving through the FDA approval process, sounds like a reasonable compromise between two opposing interests.

Re:Interesting balance

[SuricouRaven]

You have to be careful with laws. What it claims to do and what it actually does are not always the same thing. There's very little oversight in the law as written. There are also no safeguards against clinics who might use it as a legal justification to sell patients ineffective drugs at 'you'll die without it' prices.

I think the problem is that the bill was not motivated by acting in the interests of patients, but by people following the ideological position that all regulation is wrong and the government needs to just step aside and let industry solve all our problems.

Re:Interesting balance

[Registered Coward v2]

You have to be careful with laws.

Exactly. This really doesn't change anything as far as access to such treatment is concerned, as major drug manufacturers do not have to provide medicines and insurance companies do not have to pay for non-FDA approved treatments; especially since, per TFA, the FDA approves almost all expanded access requests. A legitimate drug company has a number of reasons to not let early stage drugs out into the market willy nilly, the least of which is teh potential for lawsuits if it tuns out they are prove to be unsafe. It does however, allow shady operators to function with minimum oversight and limits the FDA's ability to oversee or use results when determining if a drug is safe and effective. Legitimate companies I can see the real beneficiaries as shady operators who take advantage of desperate people with the money to pay for expensive and unproven treatments.

So what is the problem they're trying to solve?

[quantaman]

It sounds like a great idea, give patients a last chance they'd otherwise lack, but according to the article:

The measure, championed by Sen. Ron Johnson, R-Wis., is designed to give patients an alternative way to obtain drugs not approved by the FDA. Currently, there are two options for patients seeking experimental medications: enrolling in clinical trials if they are eligible or participating in the FDA's "expanded access" program. The agency has said that it approves almost all such requests to that program.

and

Critics also note that drug companies, not the FDA, are the main obstacle to seriously ill patients getting unapproved drugs outside clinical trials. Manufacturers sometimes don't have large enough supplies to provide drugs outside trials or don't want to risk a safety problem involving a drug that has not yet passed FDA muster.

It doesn't sound like anyone is denied effective treatment in the current system (unless they end up control in a clinical trial) so I'm not sure what the new bill is going to do other than potentially open the doors to snake oil sellers.

government power stroke

[datavirtue]

Struggling to pass common sense laws about things the government should not be involved in is just a protracted way to further cement government power over everything in your life. The debate is always focused on a tangent. The goal which is always accomplished is for everyone to look to government to bless everything.

If you are dying what right does anyone else on this planet have to say about what treatments you can try? Ethically, no one.

empathize with yourself and your family

[Karmashock]

if you or someone related to you were dying... would you want the government forbidding you trying something that might work?

Yes?
No?

A lot of things the government presumes to dictate are none of its business.

Except for marijuana.

[shess]

You can try some random crap made up by a guy in a lab coat if you think it will help ... unless it's marijuana. You can't try that, it's far too dangerous for you.

Or LSD, that's also been defined to not ever be useful for medical treatment under any circumstances. It's so not useful for medical treatment that you can't even research whether it might be useful.