The Promising Pathway Act

[Richard]

Hi All,

 

I just heard of the The Promising Pathway Act. This bill establishes a provisional approval pathway for medicines intended for serious or life-threatening diseases. The period of the provisional approval is for two years and is potentially renewable.  The Food and Drug Administration (FDA) must establish a priority review system to evaluate completed provisional approval applications within 90 days of receipt. A provisional approval application may be approved if the FDA determines that (1) there is substantial evidence of safety for the drug; and (2) there is relevant early evidence of efficacy, based on adequate and well-controlled investigations.

 

https://www.congress.gov/bill/116th-congress/senate-bill/3872

 

 

Perhaps if contacting your state senate representatives, faster action may occur.

 

Richard

 

[Elizabeth Pacheco]

Waiting for approval of the drugs that we need such as Amylyx has proved to be extremely slow and frustrating. It seems that the FDA bureaucracy is a slow and painful grind. Painful for Als patient who simply must wait while their bodies weaken and degenerate. Yes we definitely need to nudge our congressmen and let them know that it’s time to wake up to our plight and get this bill signed.

 

[Richard]

I agree with you.  Unfortunately, trying to get the FDA and Congress to move any faster is like a nail competing against a hammer.

 

Though, the FDA and Congress are not the only ones to blame.  People directly involved with ALS foundations are also to blame.  As an example, several months ago the ALS Association was touting their success in their effort to work with the House of Representatives in passing the ALS Disability Insurance Access Act. Below is a quote from their email:

 

“Over the last four years, YOU have helped build the momentum and support for this bill. From a single sponsor when it was originally introduced in 2016…”

 

I couldn’t believe what I was reading.  I wouldn’t be very proud of the fact that it took 4 years to pass. Rather, I’d be embarrassed!

 

 

[Author]

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