Researchers Explain How FDA Should Implement Right to Try Law
With the federal Right to Try Act now the law of the land, three academics are offering recommendations to FDA to try to help prevent the rise of unproven therapies and preserve the ability to collect critical information about investigational drugs, while enabling access.The three academics from the University of Pennsylvania, Georgia State University College of Law and Harvard Medical School explain in a JAMA viewpoint what the new law does and how it is similar to and different from FDA’s expanded access program.
FDA said in late May that it is convening an internal group to assess how to implement the new law.
Recommendations
In terms of what FDA should do, the academics lay out clear explanations in three categories: eligible patients, eligible drugs and reporting requirements.
For patients, the academics say that they “should be informed of the drug’s investigational status; anticipated risks and benefits; statutory limitations on the liability of a sponsor, manufacturer, prescriber, dispenser, and ‘other individual entity’; and the existence of Expanded Access as an alternative pathway to secure access to investigational products.”
The academics also call on FDA to further clarify what investigational drugs are eligible under Right to Try.
“FDA should clarify that (1) its regulatory definition requiring that a phase 1 study “permit the design of well-controlled, scientifically valid, Phase 2 studies” applies in this context and (2) active development means that the sponsor has submitted a phase 2 protocol to its Investigational New Drug (IND) application file,” they write.
And though not a requirement of the new law, the academics also call on FDA to monitor the development of investigational drugs used under it.
“FDA should also monitor the continuation of active development for the duration of use under this pathway. This approach could help ensure that Right to Try is not used as a preapproval marketing tool or a substitute for clinical study of drug safety and effectiveness,” they write.
JAMA Viewpoint