Thread by @bsw5020

When the House and Senate formed ALS Caucuses at the request of advocates I was elated.

Those who represent us recognized that we needed to act now to end a 100% fatal, 160 year old disease.

That enough was enough. /1

The Caucuses have helped transform the fight—raising funding, awareness and helping pass SSDI reform.

I and the entire ALS community are grateful to these amazing champions.

But we need them more than ever right now to pass ACT for ALS. /2

Today more than 50% of ALS patients, including me, are excluded from being a part of ANY clinical trial.

This means we have no way to access promising therapies and are simply left to die.

I hope we can all agree that this is not right. /3

There is an existing @US_FDA pathway that could change this. It’s called expanded access.

It has been used with amazing success in cancer but almost never in ALS.

Why?

Because companies developing ALS therapies are mostly small and can’t afford to pay for expanded access. /4

ACT for ALS fixes this by providing funding for NIH research grants for FDA approved expanded access programs.

Say what?

ACT for ALS allows small companies to apply to NIH for funding for an expanded access program to treat patients excluded from clinical trials. /5

The applications have to explain how the company will use the expanded access program to help further research into the therapy.

Once NIH approves the program, FDA then has to review to make sure the expanded access program will not harm the clinical trial for the therapy. /6

So ACT for ALS allows for access to promising therapies for patients who otherwise are just left to die, facilitates more research and does not harm a single clinical trial.

But wait, that’s not it! It also creates a public-private partnership to attack all neuro diseases. /7

And it funds a grant program at FDA to speed all neuro research.

Supporting this bill should be literally the easiest thing for a member of Congress to do.

In fact of the 6,000 bills introduced in the House, ACT for ALS is 1 of 3 with more than 300 co-sponsors. /8

Yet there are dozens of members of the ALS Caucuses in the House and Senate who are not supporting ACT for ALS.

This. Is. Unacceptable.

These members are good people, who I respect, but if they aren’t supporting by Labor Day I will post a list with their names every day. /9

For the last year, as we progressed and too many died, we worked hand in hand with FDA, NIH, Congress and advocacy groups to craft this bill and answer every question.

It’s time to move this bill to votes. It’s time to give dying patients a chance to live. #ItsTime /end