RIGHT TO TRY - Signed Into Law. Will Help Terminally ill Americans Bypass FDA Restrictions.

May 30, 2018

Today, President Trump signed into law major legislation which enables those who are terminally ill, to LEGALLY try experimental drug treatments.

On January 30th, President Trump used part of his State of the Union address to press Congress to focus attention in 2018 on a new health priority -- the passage of "right to try" legislation. It passed, and the president signed it today.

Right to try legislation gives terminally ill patients the right to use experimental medications that have not yet been approved by the Food and Drug Administration.

President Trump's push for the passage of right to try nationally builds on the efforts of the libertarian-leaning Goldwater Institute, which has used the broad popularity of the policy to help achieve passage of similar legislation in 38 states, although the state legislation differs substantially from the version signed by the President today.

Excerpted from: www.cbsnews.com...

Only 22 Democrats voted 'YES' for this legislation: www.whitehouse.gov...

NYTimes says 'Right To Try' already exists...and doesn't work: www.nytimes.com...

IMO, this RIGHT TO TRY legislation will open the door to easier FDA approval of some medications, save lives, and other benefits that we haven't thought of yet. A "win-win", from a President who tries his best to keep his promises to the American people.


-CareWeMust

a reply to: carewemust

Does that mean that insurance will pay for it? Don't think so. Sounds good on paper - rich people won't be breaking the law - but not much good in practice for the constituency.

Oh, I forgot for a minute - Rich people are the only constituency.

a reply to: carewemust

IMO, this RIGHT TO TRY legislation will open the door to easier FDA approval of some medications, save lives, and other benefits that we haven't thought of yet.

Just one example of how your source contradicts your opinion. Did you read it?

Providing the drug to patients outside of clinical trials can also be disruptive to the approval process because it can lead to data on negative clinical outcomes outside the highly controlled trial setting. While new legislation prevents this data from being used unless it is deemed "critical to determining safety," bad outcomes might give the FDA pause and delay the approval of drugs that might otherwise be available sooner.

Beyond these issues, federal right to try legislation will have minimal impact on the availability of experimental drugs for patients. Not only have 38 states already passed similar legislation, but the FDA already has a program in place designed to provide patients with experimental medications.

The right to try legislation will score the president and members on both sides of the aisle in Congress points, but ultimately it will change little for terminally ill patients and their families.

a reply to: Phage

The negative slant is provided by CBS and the FDA.

I would not trust either for an honest opinion.

As usual, your anti-Trump stance is obvious. It is your right to have whatever opinion you choose.

P

a reply to: FyreByrd

How does this new law compare to California's ?

✍

originally posted by: FyreByrd
a reply to: carewemust

Does that mean that insurance will pay for it? Don't think so. Sounds good on paper - rich people won't be breaking the law - but not much good in practice for the constituency.

Oh, I forgot for a minute - Rich people are the only constituency.

There are non-FDA approved medications that don't cost a fortune. When you're dying, a lot of resources CAN come to assist you, in your quest to live longer.

a reply to: Phage


You're correct. There are pros and cons to everything. If you're terminally ill, having the RIGHT TO TRY is a good thing, from your perspective.

There IS an existing law called "Compassionate Use" that allows drugs to be used, not just for terminally ill patients but for those suffering chronic conditions not alleviated by conventional approved therapies. It's darn hard to get approved for it, though.
I took care of a vaccine-injured child that had 165 grand mal seizure a week and was allergic to valium and phenobarbital. He did take Dilantin which knocked his seizures down to only 165 a week but the standard treatment for an epileptic episode is valium and/or phenobarbital which he could not take. I worked with his family and Dr. for months, sending documentation to the appropriate agencies and arguing for approval for compassionate use drugs to no avail.
Hopefully this new legislation will ease the restrictions for patients like this and allow them some actual compassionate use of available medications.

a reply to: carewemust


I think this is a good thing.

It will broaden the discussion, it will make more people aware.


Overall, I see it as a positive.

a reply to: carewemust

You're correct. There are pros and cons to everything. If you're terminally ill, having the RIGHT TO TRY is a good thing, from your perspective.

Yes. If you can afford it. But, as has been pointed out, in most states you have already had that option.

But it won't help bring more effective drugs to the market faster. It will not bypass clinical trials.

a reply to: Phage

Caution! Personal opinion alert.
With the plethora of commercials advertising various medications for anything that ails you (some with truly unpleasant side effects or even contraindications for the recommended use), I believe we're seeing Beta trials in real time. I've not done any research (and don't know that anyone has) but I wonder how many of these drugs are later quietly removed from the market due to the lawsuits or unexpected outcomes? (Celebrex-later re-introduced) Worse, I wonder how many HAVE FDA approval and are still on the market despite the known hazards. Giardasil and flu vaccines spring to mind for the latter category.
I guess we'll have to take a wait-and-see attitude regarding how this will affect FDA approval of new drugs.

Expanded Access (Compassionate Use) Info.

If this law does nothing else, it will insure that we don't have armed police standing outside of a hospital keeping parents from taking their child elsewhere for treatment.

Any law that says people have the right to do something that doesn't hurt anyone, I'm all for it.

originally posted by: Phage
a reply to: carewemust

IMO, this RIGHT TO TRY legislation will open the door to easier FDA approval of some medications, save lives, and other benefits that we haven't thought of yet.

Just one example of how your source contradicts your opinion. Did you read it?

Providing the drug to patients outside of clinical trials can also be disruptive to the approval process because it can lead to data on negative clinical outcomes outside the highly controlled trial setting. While new legislation prevents this data from being used unless it is deemed "critical to determining safety," bad outcomes might give the FDA pause and delay the approval of drugs that might otherwise be available sooner.

Beyond these issues, federal right to try legislation will have minimal impact on the availability of experimental drugs for patients. Not only have 38 states already passed similar legislation, but the FDA already has a program in place designed to provide patients with experimental medications.

The right to try legislation will score the president and members on both sides of the aisle in Congress points, but ultimately it will change little for terminally ill patients and their families.

I would think the FDA and the AMA would do everything they can to block this !! Curing someone is a very bad business model.

a reply to: VictorVonDoom

If this law does nothing else, it will insure that we don't have armed police standing outside of a hospital keeping parents from taking their child elsewhere for treatment.

That's an interesting point, but the law seems to be silent on parents allowing such treatment for terminally ill children. It seems to apply only to the patient, presumably an adult patient. So the lawyers still have jobs.

“(a) Definitions.—For purposes of this section—

“(1) the term ‘eligible patient’ means a patient—

“(A) who has been diagnosed with a life-threatening disease or condition (as defined in section 312.81 of title 21, Code of Federal Regulations (or any successor regulations));

“(B) who has exhausted approved treatment options and is unable to participate in a clinical trial involving the eligible investigational drug, as certified by a physician, who—

“(i) is in good standing with the physician’s licensing organization or board; and

“(ii) will not be compensated directly by the manufacturer for so certifying; and

“(C) who has provided to the treating physician written informed consent regarding the eligible investigational drug, or, as applicable, on whose behalf a legally authorized representative of the patient has provided such consent;

It seems a parent would qualify under (C).

But, it's unfortunate that on the flip side, parents can legally withhold proven treatments for their children who could otherwise live. Things like blood transfusions. Devil's work.

a reply to: 727Sky

I would think the FDA and the AMA would do everything they can to block this !!

It's a little late for blocking it. It's the law of the land. And it has been so in most states for a while now.
Have you looked into what the positions of those organizations are?

a reply to: Phage

LOL,use the drug company's quotes and figures,do you think they would show anything different?got some swamp land to sell

a reply to: Oldtimer2

What?

a reply to: Phage

Good post. I saw this on the news yesterday and thought it was a great idea. I didn't realise it was already in practice. Now I think about it, it's looking more obvious that the field of medicine would be open to trialling experimental, novel treatments with the consent of terminally ill patients.

A friend was diagnosed with cancer and was one of a sample of a 100 on an experimental treatment. He was given three months to live and lasted just over two years. Just an anecdote to say it's an approach used in the UK too.

But, it's unfortunate that on the flip side, parents can legally withhold proven treatments for their children who could otherwise live. Things like blood transfusions. Devil's work.

Indeed. There's a social media myth that somehow parents are all balanced, informed, educated and sane. It's why we need checks and balances. Little Suzy won't survive skin cancer by chanting Jesus and writing letters to TV evangelists.

a reply to: Kandinsky

Now I think about it, it's looking more obvious that the field of medicine would be open to trialling experimental, novel treatments with the consent of terminally ill patients.

But the science part of medicine recognizes that, lacking controls, any results gained (or lost) will not add to the knowledge base. Each case (whatever the outcome) will be anecdotal. If the patient survives, for ever how long, there is no statistical basis to support the treatment. If the patient suffers terrible side effects, there is nothing to hinder the next patient from suffering the same.

a reply to: Phage

True, but success could still lead to clinical trials.

It's nice for people to imagine 'Eureka moments' from compassionate lab-coated pharmaceutical scientists. In reality, it isn't like that.