The rare disease advocacy group Haystack Project told Inside Health Policy that they are working with Senate and House lawmakers including the House Energy & Commerce Committee to develop new legislation to allow alternatives to randomized controlled trials (RCTs) for rare disease products. Haystack does not back existing legislation that would create a limited-term conditional approval pathway; instead, it’s arguing that FDA’s overarching “substantial evidence” standard should remain intact, but that action from Congress is needed to ensure alternative...