Right to Try Laws

agness · 02-04-2016, 05:09 PM

Hi all,

This past Tuesday I went down to Olympia, WA and gave testimony to my situation and why I want the Right to Try legislation passed in Washington State.

I heard back from the Senator this afternoon that the senate health committee voted in favor of SB 6550 -- perhaps even unanimously. It has to go for a vote before the full Senate and then the House health committee and full House for another vote before it might be signed into law. Still a ways to go now.

The current FDA Investigational New Drug program entails access via 1) clinical trials, 2) compassionate use, and then 3) expanded access (a sort of holy mary pass approach to dying patients). We all know that the clinical trial game doesn't work for all of us for any number of reasons -- age, distance, previous drugs we were on, type of disease, etc.

Compassionate use is even more of a nightmare, the FDA says that they will take no more than 30 days to review these applications but they estimate it will take 100 hours of uncompensated time on the part of the physician to make the case for accessing the medications outside of a trial. No wonder we are letting so many patients die and not get access to meds and treatments that might help them.

If you are in Washington State please write in support of this legislation. It really can mean the difference between life or death for so many patients.

Find your WA State reps here:
http://app.leg.wa.gov/districtfinder/

MaineRottweilers · 02-04-2016, 05:53 PM

I don't live in WA bu I want to say thank you for forging ahead in spite of all you have going on and working toward making it easier for everyone facing a life threatening health battle.

agness · 02-04-2016, 11:27 PM

http://apps.leg.wa.gov/billinfo/summ...2016&bill=6550

Find your Washington State reps here:
http://app.leg.wa.gov/districtfinder/

----------

If You Are in a State That Doesn't Yet Have Right to Try

Write to your state reps (house and senate) and tell why you think they need this law in your state.

Right to Try Laws are Already Happening

Point out that it has already passed in many other states and include the RAPS legislation link. They can easily get a hold of what the laws entail that way which helps move it more quickly. Point out that your state is behind this and the citizens deserve these rights.

RAPS - Right to Try Legislation Tracker
http://www.raps.org/Regulatory-Focus...slation-Tracke...

What About Liability?

Patients, oncology professionals, drug companies and limitation of liability are already things that are happening through the Investigational New Drug program. Drug manufacturers can decide whether it is a reasonable request as well. This just helps get access without getting caught up in clinical trial process that is oriented towards bringing drugs to market -- that is a strange realization but true, folks are being denied due to business-driven factors.

Who Would Pay?

The patient is responsible for treatment costs. Insurance companies don't pay for clinical trials or unapproved drugs right now and that wouldn't change. Drug companies can decide to charge less and insurance companies sometimes do pay peripheral costs. It needs to change but given the alternatives right now I would rather have the option than not. We will have to fight the clinical trial funding battle a different way.

Make it Personal

Give them a real sob story too - about a friend or loved one, or yourself. My friend who drove me to Olympia ran into someone yesterday while waiting for the school bus and the other woman immediately had a story about how her husband had died from brain cancer tens years ago and absolutely she was in support of it. You probably know many stories and they aren't all cancer-related as there are other conditions that also might benefit.

Why Right to Try?

Someone in the WA State House of Representatives framed it this way in the context of the laws in our state: if we allow patients the right to Death with Dignity they why can't we also give patients the right to try to save their lives?

Some Poignant and Timely Oncology Drug Stats

This is a really compelling article when you get to the middle and see the drug development pipeline stats:

"Across the pharmaceutical industry as a whole, the oncology pipeline is far larger than any other therapy area, with 6,484 products in active development across all oncology indications, reflecting this unmet need. Of these, some 2,084 are first-in-class, meaning that they act on a molecular target not targeted by any marketed product across the industry. Some 46% of pipeline oncology products with a disclosed molecular target are first-in-class, reflecting a very high level of innovation."

http://gbiresearch.com/media-center/...sites-ushers-i...

Look how many drugs -- over 2000 -- are the first of their kind and yet aren't available yet.

sarah · 02-05-2016, 10:36 AM

I will write to any friends who I know live in Washington in the hopes they will join in support and write their representative. I believe strongly that we should be able to do whatever we want to do in order to live. We can know the risks but we should have the right to chose.
good luck
sarah

agness · 02-27-2016, 07:36 AM

I was so shocked by what occurred that I didn't post an update.

After passing the WA State Senate Health committee unanimously the Right to Try legislation was blocked by Senator Andy Hill (R) who wouldn't even let it get heard on the Senate floor to be voted on. Senator Hill believes evidently that by giving terminal patients access to developing meds that a) no one will participate in clinical trials, and b) no one will take the chance in a trial of getting the placebo.

The WA medical association, the hospital association, the biotech industry and even a major health insurer in our state all tried to lobby in FAVOR or getting Right to Try in Washington. Senator Hill has clearly demonstrated a lack of leadership and getting caught up in a personal agenda over the needs of the people.

Senator Hill was able to participate in a clinical trial for inoperable lung cancer and was cured. I have checked with four HER2 specialists and with my leptomeningeal diagnosis I am ineligible, it is a stated exclusionary criteria for almost ALL trials. The only trials I might participate in are IT Herceptin which I am already receiving off-label, or through FDA Compassionate Use which several oncologists have dismissed as too lengthy and complicated paperwork-wise.

Right to Try legislation is dead for 2016 in Washnington and cannot be heard again until 2017. Ours was based on Colorado's laws with some modifications. Gov Briwn if California objected to their approved legislation but it was entirely different and was not restricted to terminal patients.

thinkpositive · 02-27-2016, 12:05 PM

Wow, it is unbelievable that Senator Hill was able to participate in a trial that saved his life but wasn't for the Right to Try. This doesn't make any sense. Disappointing news for sure.

sarah · 02-28-2016, 02:50 AM

sounds like next time Hill is up for election, he should be voted out. He doesn't like "by the people"! or "for the people"!

donocco · 02-28-2016, 12:10 PM

I tried to look up on the internet what was going on in the State of Washington and Right to try and Andy Hill. I found nothing. Its sad but I think they are starting to censor the internet.

I first realized this when I tried to get info on a drug called Movantik. This drug blocks opiate receptors in the intestine and is approved to treat Opiate induced constipation. One tiny little glitch. The FDA approval reads Movantik is approved for non cancer opiate induced constipation. In other words if the opiate induced constipation is in a cancer patient on say Morphine SR the insurance companies wont pay for the drug. To use Movantik in a cancer patient would be called "experimental" that favorite insurance catchword. Supposedly Movantik is being used in cancer patients in Europe.
I tried to find info on this. Once again-nothing on the internet. All the internet articles say the same thing- Movantik is FDA approved to treat non cancer induced opiate constipation- no argument no debate. You may as well make soap a drug and FDA approve it for non cancer uncleanliness.

They always say "Follow the money." Who makes money on actual Clinical trials with placebo etc. This could be why Andy Hill is opposed to right to try laws. Please forgive any misspellings.

Paul

phil · 03-03-2016, 06:11 PM

So Sen . Hill, one of the very few lucky enough to get into the tiny old fashioned trials , decides he knows what's best for the un - lucky who have to beg for a few compassionate use slots. I hope you Washington state residents remember this at Election time.

agness · 03-03-2016, 09:01 PM

Thanks to Senator Andy Hill Right to Try legislation is dead for this year. No, I don't know why one person has the audacity to block a vote on legislation in that manner, limiting the voice of the people. I think he thought it would pass and that's why he did it and he believed he wouldn't face political repercussions. He just got sworn in for another term last year so maybe 2020 pay attention to his ambitions.

So to regroup and think about other angles on this, the FDA in February 2015 announced that they had submitted a draft revised Expanded Access form; that plus they were shortening up the form review period to 30 days.

FDA blog: A big step to help the patients most in need (Feb. 4, 2015)
http://blogs.fda.gov/fdavoice/index....-most-in-need/

The travesty is that it took an FDA regulator's own wife dying of cancer for these revisions to happen.

F.D.A. Regulator, Widowed by Cancer, Helps Speed Drug Approval
http://mobile.nytimes.com/2016/01/03ś/us/politics/fda-regulator-widowed-by-cancer-helps-speed-drug-ap...

So I decided to contact the FDA to see about this revised firm and what the status of it is. Surely anything that improves the process and cuts down on the amount of time required of practitioners the better, right? I just heard again last week that it is too complicated the current form and process. Yeah, that's a great excuse - it takes too much time.

The FDA replied to my email today, just one day after I sent it in:

Thank you for writing to the Division of Drug Information, in the FDA's Center for Drug Evaluation and Research.

Our current process along with all necessary forms for Expanded Access (Compassionate Use) can be found here
http://www.fda.gov/NewsEvents/Public...m#How_To_Apply

Additionally, please refer to the

Individual Patient Expanded Access Applications: Form FDA 3926 (Draft Guidance for Industry).

As part of the rulemaking process on proposed rules, there is an opportunity for the public and other stakeholders to submit comments on the proposed rule by visiting the regulations.gov webpage here: http://www.regulations.gov/#!docketDetail;D=FDA-2015-D-0268, and click on “Comment Now.” You may submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Please make sure to reference the docket number for your comments.
When finalized, draft Form FDA 3926 is intended to provide a streamlined alternative for submitting an investigational new drug application (IND) under § 312.23for use in cases of individual patient expanded access.

Once the comment period and the review process is complete, the form and Final Guidance will be posted on the FDA website. It is unknown how long this process will take.

We appreciate you taking the time to contact us.

What to do? Submit comments? The only ones there earlier today were from last Spring. Spread the word to patient advocacy groups? Sure, put the pressure on the FDA. Contact the media? Sounds like a great addition to the Right to Try story.

Debate Over Right-to-Try Laws in the States - NPR
http://thedianerehmshow.org/shows/20...-in-the-states