Providing for Congressional Disapproval Under Chapter 8 of Title United States Code, of the Rule Submitted By the Office of the Comptroller of Currency Relating to ``National Banks and Federal Savings Associations As Lenders''

Floor Speech

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Mr. BRAUN. Madam President, today I am proud to join my colleague Senator Coons in relaunching the bipartisan Senate ALS Caucus.

Currently, there are no effective treatments or cures available to stop or slow the disease, and we still do not know what really causes ALS.

More than 5,000 Americans are diagnosed each year. Yet there is no ALS survivor community. Individuals diagnosed with ALS and their loved ones rely on their elected officials to advocate on their behalf.

That is why the mission of the Senate ALS Caucus is to raise awareness about the difficulties faced by ALS patients and their families and to advance policies that improve their quality of life to advocate for meaningful research.

May also marks ALS Awareness Month. Last Congress, Senator Coons and I introduced and passed a resolution to designate May 2020 as ALS Awareness Month. This effort, like the ALS Caucus, will raise awareness about the impact of ALS on those who are diagnosed, their loved ones, and their caregivers.

I look forward to reintroducing again here in May 2021 the awareness month for ALS, and I hope my colleagues will help to pass this resolution again this year.

There is more to be done, though, in really battling ALS. Promising therapies that have demonstrated clinical safety and efficacy are on the horizon for those with ALS. Failure to approve those promising treatments means the difference between life and premature death for these patients, and, sadly, the paradigm of the past has been to not be erring on the side, when there is a promising treatment, to push it through the system. Sadly, it has been indicative of what happens often in this place, and that is that you belabor it, you stretch it out, and, in this case, it has a much different consequence

Patients with ALS have been very clear that they are willing to take a higher degree of risk to have access to these treatments at an earlier point in time.

In September 2019, the FDA issued new guidance on developing drugs for ALS, which touted regulatory flexibility when applying the standard of safety and efficacy to drugs or diseases with serious, unmet medical needs. FDA guidance has been an empty promise, and patients with ALS lack flexible regulatory pathways to promising treatments as a result.

Indicative, in a way, of what I mentioned earlier, where we seem to always be aware of those kinds of issues, we tell the Agencies that might be involved, and then there is that natural tendency toward inertia.

For example, Amylyx, a pharmaceutical company focused on developing ALS treatments, announced clinical trial results of a promising treatment that slowed the progression of the disease and increased survival by 6 months. It may not seem like a long time, but when you take into consideration from the point of diagnosis to the point of dying from ALS, that is a lot of time, and the benefit of the doubt, when you have a promising clinical trial, needs to be given to the patient so that they have some hope.

Europeans and Canadians have put a dynamic into place that would be quicker footed than our own FDA's. We need to take that as some guidance.

Unfortunately, the FDA has expressed the need for additional clinical trials before allowing patients to access these drugs in the United States. This means Americans with ALS will not receive access when they can see others in Canada and Europe being able to.

We need to get with it, and when you have the condition of no effective treatment and it is working in other places, we need to give the benefit of the doubt.

It is failing to use its flexibility, and we have just seen--and I witnessed, all of us did, with the coronavirus--FDA, CDC squabbling out of the gate about what to do with coronavirus.

Thank goodness we did do something that was going to change that dynamic. We would still be wrestling over a vaccine if it had been business as usual.

So it is clear here, for even a better reason, that nothing is out there that is working, promising things on the horizon. We need to do better. That is why I will be reintroducing the Promising Pathway Act, the legislative solution to give those struggling with life-threatening illnesses, like ALS, a fighting chance of access to timely, meaningful treatments, especially when they are overwhelmingly wanting it, willing to take the risk.

The Promising Pathway Act would require the FDA--require the FDA--to establish a rolling, realtime priority review to evaluate the progress and not make it subjective, the way it is now, to where they can do what they have been doing, and that is dragging their feet.

Under this pathway, provisional approval would be granted by the FDA to drugs demonstrating substantial evidence of safety and relevant evidence of positive therapeutic outcomes, like those demonstrated in Amylyx's clinical trials.

It is right here. We just need to do it, and you are going to be doing what ALS patients would prefer.

This also encourages further research and clinical trials in not only ALS, but this, of course, should apply to other diseases that are similar where we are still wrestling, in clinical trials, with the ability to get these across the finish line. But it does strengthen the FDA's postmarket surveillance, which is another important thing for patient safety, and grants access to promising treatments covered by insurance.

To my colleagues, it is time to roll up our sleeves and to work to advance policies that improve the quality of ALS patients. I encourage every Member to lean in on this, to be a part of it, so that we can help people that have no other hope.

It is up to us to speak for those who can no longer speak, to stand up for those who can no longer stand.

I am grateful to my colleagues on both sides of the aisle who are returning members of the ALS Caucus, and I welcome those who are new to the caucus this Congress.

As the ALS Caucus continues to grow its membership, our commitment to the mission of the ALS Caucus and the ALS community is strengthened along the way.

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