Haystack Project

Observation #1: While NASEM confirmed Haystack’s long-held belief of “outsized impact” to rare disease patients from the?inextricable link between FDA processes, pricing and payer decisions,?nothing in the statute directed NASEM to conflate access, pricing, and payer decisions in the study Congress required of them. We oppose efforts to begin cost containment needed across the US health care system with children dying of rare diseases. https://lnkd.in/ekCjpdpm

CEO of Haystack Project, Kara Berasi, provides public comment at the Advancing Rare Disease Therapies Through an FDA Rare Disease Innovation Hub https://lnkd.in/g-Q3TQXN

Finishing up the week by highlighting another article surrounding our Capitol Hill event https://lnkd.in/eFyshN2m

Haystack Project, whose membership comprises rare and ultra-rare disease patient advocacy organizations, also raised concerns about the draft guidance’s language on waivers. ? “Several of Haystack Project’s member organizations expressed concerns with FDA’s stated intentions on DAP waivers and suggested that FDA implement a presumption that studies in populations with fewer than 2,000 patients would qualify for a waiver,” the group’s?comments?state. “The final guidance should also include details and examples illustrating its view on instances for which a DAP would be impracticable.” https://lnkd.in/e9Sug-np

Check this out! Haystack Project is featured as the 'Top Story' on Inside Health Policy today!

Haystack Project in the news!

Haystack Project in the news on the heels of a great event last week. If you weren't able to make it, stay tuned for the recording you can listen to on your commute/morning walk... https://lnkd.in/ebKxsKG9

An important event yesterday, but only the beginning. A new approval pathway for rare is critical. Thank you to all who attended and to those who have already contacted Haystack to join upcoming Roundtables. Look forward to hearing from more of you.

RSVP Link is LIVE: https://lnkd.in/eGMxej_F

This one you don’t want to miss!