Federal Right-to-Try Legislation — Threatening the FDA’s Public Health Mission image

NEJM, January 10, 2018
Steven Joffe and Holly Fernandez Lynch (Academic Fellow Alumna and former Executive Director)


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From the article:

The Food and Drug Administration (FDA) is the gatekeeper of the country’s drugs and medical devices. Originally created to prevent the misleading of patients, it was later tasked with ensuring the safety of medical products. In 1962, Congress expanded the FDA’s mandate again, requiring it to determine that medical products are effective for their intended use and that their benefits outweigh their risks. Access to products that are not yet FDA-approved is typically restricted to participants in clinical trials. Consequently, some patients who might benefit from investigational drugs cannot obtain them.

Recognizing this problem, the 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.

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bioethics biotechnology fda health law policy medical safety pharmaceuticals public health regulation