House Approves `Right-To-Try` Bill; Does not advance in Senate

In a vote of 267-149 the House of Representatives handily approved the Right to Try Bill on March 21, 2018.

H.R. 5247 narrowed the scope of eligibility to patients in whom there is a "reasonable likelihood that death will occur within a matter of months" or a "disease or condition that would result in significant irreversible morbidity that is likely to lead to severely premature death".

The Bill requires the completion of phase 1 clinical trials, the drug is in active clinical development. This Bill also requires the public website posting of an annual summary of the provision of investigational drug via this mechanism, including number of requests, number approved, therapeutic area, and adverse events.

This comes on the heels of last week's failed vote using the special fast track procedure requiring two-thirds support. The standard simple majority rule was used for the vote on March 21.

At this time, requests for investigational drugs are managed under the mechanisms for Expanded Access. Early Access Care LLC (www.earlyaccesscare.com) provides consultative, functional and operational support to biopharmaceutical companies for Expanded Access and Compassionate Use. EAC provides end to end management of single-patient requests, as well as developing and implementing Expanded Access Protocols. Contact us (info@earlyaccesscare.com) for assistance in managing how the new Right to Try bill impacts the manner in which you respond to requests for expanded access.

Addendum:

1. On March 23 Wisconsin's Sen. Ron Johnson called for a unanimous consent vote on HR 5247. The bill did not advance.
2. On March 28, Wisconsin became the 39th state with a RTT law. Nine states currently have bills pending.