Read Brian Wallach's Testimony to Congress May 19, 2021

Everyone should read Brian Wallach's testimony to Congress.  His testimony, which you can read here, brilliantly advocates for more federal support for ALS research and clinical trials.  It condemns the FDA's abject failure to put treatments in line for patient care, worrying instead about the affect of these therapies on people with a fatal disease.  Everyone should urge their Congressional representatives to pass the legisliation dicussed by Brian and to pressure the FDA to make the necessary changes and grant the approvals for treatments for ALS.    Here is just some of what Brian said:

So I come to you today with two urgent asks. Ones that if you make real will change my and millions of others’ futures.

First, fund ARPA-H and include ALS among its’ core disease areas. During the 2020 campaign then-candidate Joe Biden promised ALS patient Ady Barkan that he would seek to create ARPA-H, modeled after DARPA, to solve issues relating to the diagnosis and treatment of disease. He also promised that ALS—along with cancer, diabetes and Alzheimer’s—would be among the first diseases it tackled.

Second, we need you to hold FDA accountable for failing ALS patients by denying any type of approval for two promising therapies this year.

I implore Congress to hold hearings on these denials to bring transparency and accountability to a process that has left the ALS community devastated.

In addition to hearings, I ask you to pass and fund 2 bipartisan bills to ensure this does not happen again. Over the last year, the fight against COVID-19 showed how much regulatory flexibility FDA has when it wants to use it. Since FDA appears unwilling to use it to give ALS patients a chance to live, we have worked with members of Congress to reform how FDA approaches diseases like ALS.

The first, ACT for ALS, is being reintroduced this week. It will, among other items, make a significant amount of funding available to establish expanded access programs. Programs that will make promising therapies available to ALS patients now while fueling additional research into a therapy’s safety and efficacy.

The second, The Promising Pathways Act, was reintroduced in the Senate last week. It will, among other things, allow for conditional approval of promising therapies after Phase II for life-threatening diseases like ALS. This would put us on par with Europe.

Today, the science needed to cure ALS is moving faster than ever and finally producing therapies that may be able to slow or stop this disease. This reality must be matched by a new regulatory approach that speeds promising therapies to patients. As I have outlined, despite programs aimed to do just that which have worked in other diseases, we do not have that approach for ALS today. It is our moral obligation to change this broken approach for all those facing ALS just as we did for HIV and cancer.