Right-To-Try is Practically Dead
[Thursday, September 12, 2019]

Last year when the federal Right to Try (RTT) Law was passed; it’s main purpose was to undermine FDA’s compassionate use program. A survey from GAO released this week shows the opposite. A year after becoming a federal law, the RTT is unpopular with manufacturers who prefer the FDA’s compassionate use program for providing investigational drugs. Most manufacturers surveyed by GAO expressed their concerns about providing investigational drugs outside FDA and IRB oversight as allowed by RTT, and have taken measures to practically push patients towards FDA’s compassionate use program. The main reason seems to be the fear of liability of providing products outside FDA’s oversight. Some manufacturers simply deny all RTT requests while those that, on paper, are willing to consider have created complicated processes to review and approve RTT requests, while easing FDA-compliant compassionate use requests. For RTT, the manufacturers that consider requests have formed independent review committees to review the requests and ask RTT requesters to seek IRB approval among other conditions. The RTT law does not require manufacturers to provide the requested investigational drug or biologic not does it restrict the providers from creating onerous processes. The result is an RTT law that is practically dead. The survey did not provide a count of how many RTT requests were honored but from the answers received it does not seem any patients were able to secure the requested investigational drug via RTT. On the other hand, the compassionate use program is active as always. Last year FDA had implemented several improvements in its compassionate use program intended to make it easier for patients and their physicians to use it making it further unnecessary to seek access to investigational products via RTT. The proponents of the RTT law had envisioned patients rapidly accessing investigational drugs without FDA oversight but they probably did not plan for the industry’s concerns. The RTT provides practically the same benefits as the compassionate use program without the FDA oversight and that is not acceptable to the industry. The industry prefers to work with FDA for its investigational products and RTT cannot provide that comfort. That said, the RTT law is only one year old. It may be too early to read its obituary. RTT offers a viable alternative to compassionate use, but requires the industry to be creative in implementing it. The proponents of the law need to educate the stakeholders of ways to use it so that the law that they helped create does not become worth less than the paper it is written on.