Friday, January 12, 2018
The New England Journal of Medicine recently published an opinion article, Federal Right-to-Try Legislation — Threatening the FDA’s Public Health Mission. The second paragraph sets out the issues
[T]he FDA created “expanded access” pathways to give desperate patients without other options access to promising products before approval, while still providing oversight. The agency received more than 5000 requests under those pathways between 2010 and 2014.1 But in August 2017, the Senate passed the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act, which would sharply curtail the FDA’s oversight of access to investigational drugs for patients with life-threatening illnesses.2 Though popular with the public and supported by politicians from both parties, the legislation has been widely criticized by policy experts. In isolation, its impact would probably be limited, since the bill was substantially hollowed out to secure the necessary votes. Nonetheless, the motivation behind the proposed legislation threatens to weaken the FDA’s ability to pursue its public health mission.
The article discusses the bill, the concerns expressed and the countervailing arguments. The authors conclude "[a]re we prepared to abandon the FDA’s gatekeeping role in favor of unfettered patient autonomy and market forces, risking precisely the problems that prompted Congress to grant the FDA its present authority? The agency has made substantial progress in balancing the needs of desperate patients and the principle that all patients deserve evidence that the benefits of medical products justify their risks. We upset that balance, and diminish the FDA’s public health mission, at our peril."
A pdf of the article is available here.