Recent Legislation that Secured a 'Right to Try' Unapproved Drugs: Why the 'Fuss' Over a 'Fix' of What 'Ain’t Broke'?
William M. Zoffer, "Recent Legislation That Secured A 'Right to Try' Unapproved Drugs: Why The 'Fuss' Over A 'Fix' Of What 'Ain’t Broke',? 11 Wake Forest J.L. & Pol’y 119 (2020)
84 Pages Posted: 6 Jan 2020 Last revised: 14 Dec 2020
Date Written: August 31, 2020
The significance of the federal Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 and its state counterparts is widely misunderstood. The legislation is both more and less than it may seem at first blush. This much is clear: at the federal level, it opens a new pathway, alongside the existing FDA-regulated pathway, for making promising investigational drugs available to seriously ill patients who lack meaningful alternative treatment options (“treatment use”). This Article aims to elucidate the real import of these laws by examining them in the detailed historical context of how treatment use has been regulated before the laws’ advent, and how that regulation had repeatedly been challenged, unsuccessfully, in all three branches of government. The decades-long history of those prior challenges, all of which fundamentally targeted the FDA’s broad gatekeeping role in the modern drug regulatory paradigm, is excavated in considerable depth.
Straddling this more-less dichotomy, this Article demonstrates on the one hand why the promise of the new legislation is less than proponents’ bold claims of being life-saving and transformative. To this end, this Article contrasts the new and extant pathways in light of decision factors that matter to mainstream drug developers. Their willingness to participate along any pathway is rate-limiting. Building on this view, this Article canvasses public reports through mid-2020 of actual “right to try” patient experience in order to substantiate the expectation that it would be scant, and unconvincing of broader uptake to come.
On the more side of the dichotomy, this Article analyzes the broader ramifications of these bills, even beyond the potential to incentivize questionable fringe business models. In historical context, passage of the legislation is a celebrated “first” success in a long-running series of challenges to the FDA’s broad gatekeeping authority, in this specific context of treatment use. An undercurrent of aversion toward that authority has been persistent, and naturally flows to the sympathetic context of seriously ill patients. As a number of scholars and reporters have observed, proponents of “right to try” have a broader deregulatory agenda, and their ability to have achieved a first breakthrough in the treatment use context is the greater significance of the recent legislative campaign.
Keywords: right to try, right-to-try, expanded access, investigational drugs, FDA, treatment use, Right to Try Act of 2017
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