A little more than six months ago, we reviewed then-pending federal right-to-try legislation. Since then it’s become a shiny object, capable of distracting those governing the country from more important matters. One version, H.R. 5247, just passed the House of Representatives. Another version, S. 204, which we reviewed in our prior post, passed the Senate last August.
Setting aside from our general view that right-to-try legislation isn’t enough (if any) of an improvement over the FDA’s already operating compassionate use program to be worth the legislative bother, is this version any better than the last?
The answer is yes.
First of all, it’s more limited. The prior version applied to any “life threatening condition,” without requiring that the threat be imminent. The House-passed bill is not as overbroad. This new version applies only to conditions with “reasonable likelihood that death will occur within a matter of months.” That’s much more in line with how “right-to-try” has been pitched to the public – as a matter of last resort.
The other major gripe we had with the terms of the prior Senate bill – preemption of tort litigation – has also been addressed. Last time, any immunity for manufacturers participating in the program was predicated on “compliance,” which, as anyone paying attention knows, is easily pleaded around and thus hardly worth the paper it was printed on. The relevant language now eliminates that caveat:
No manufacturer or sponsor (or their agent or representative) of an investigational drug shall be liable for any alleged act or omission related to the provision of such drug to a single patient or small group of patients for treatment use in accordance with subsection (b) or (c) of section 561 or the provision of an eligible investigational drug to an eligible patient in accordance with this section, including, with respect to the provision of an investigational drug under section 561 or an eligible investigational drug under this section, the reporting of safety information, from clinical trials or any other source. . . .
(Emphasis added). This provision does several things, all of which improve upon the prior bill. First, it eliminates the compliance prerequisite to preemption. It’s now a flat “[n]o manufacturer . . . shall be liable.” Second, as the highlighted language, above, makes clear, the same immunity from tort will apply both to right-to-try and to participation in the FDA’s compassionate use program (FDCA §561(b-c), a/k/a 21 U.S.C. §360bbb(b-c)). That’s only fair, since there is no reason in the world for a manufacturer to be worse off, from a preemption perspective, for participating in an FDA-supervised program. Third, the statute makes clear that there can be no liability for purported failure to report adverse events.
The absolute prohibition on liability for non-participation, which we liked before, is if anything stronger in H.R. 5247. We certainly don’t want to see any resuscitation of the Abigail Alliance nuttiness.
The rest of the House-passed bill also looks pretty much the same, except for a provision governing adverse event reporting both for right-to-try and for compassionate use. As before (although the language might be somewhat different), H.R. 5247 includes an informed consent provision, general reporting requirements, incorporation of the regulatory provisions limiting charges for investigational drugs, a general prohibition (with a quite limited exception) on the FDA using adverse events to interfere with the approval process of eligible investigational drugs, and limitations on liability for participating health care providers. As to this last point, there are several exceptions for aggravated conduct, one of which is a state-law “intentional tort.” Given that a few states (Pennsylvania, we know) continue to treat informed consent actions as battery claims, that language may result in broader participant liability (and thus more reluctance to participate) than the bill’s drafters intend.
We remain skeptical about whether right-to-try statutes actually help anyone, as opposed to being political grandstanding. That said, from the perspective of attorneys representing pharmaceutical companies, this bill is about as good as it could be, and – to the extent that it extends preemption to the compassionate use program – it even marginally improves current law.