Right To Try Conversation Should Be Redirected Toward Reimbursement Of Unapproved Drugs, Experts Say
King & Spalding Partner David Farber called for amending Medicare and Medicaid statutes so that unapproved treatments can be reimbursed for terminally ill patients who have exhausted all other options.
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Expanded Access Advocates Seek Reimbursement Mandate, Manufacturer Incentives From Congress
Next round of biomedical innovation legislation provides opportunity to require insurance reimbursement of investigational drugs and related medical services, as well as new incentives for small biotech companies to offer expanded access programs, stakeholders say.
Expanded Access Program Improving, But Sponsor Concerns Linger
Many stakeholders interviewed by the GAO find the US FDA's updated guidance on treatment of adverse event data gathered under expanded access to be helpful, but some continue to be concerned that the data will be used to negatively impact development programs.
Gottlieb: Lack Of Compromise On Right-To-Try Bill Is 'Interesting Lesson In Politics' For Stakeholders
In interview with the Pink Sheet, former US FDA commissioner Scott Gottlieb said that opposition to the modified House version of the right-to-try legislation ultimately led to the less favorable Senate bill becoming law.