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Gottlieb's "Right To Try" Sentiment: Law Fails To Address Difficulties Faced By Drugmakers

Executive Summary

US FDA Commissioner suggests Congress may need to explore incentives for drugmakers to make investigational products available in the pre-approval phase. 

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Passive Adverse Event Approach Is Key Facet Of US FDA's Right-To-Try Rule

Sponsors will have little obligation to conduct due diligence of adverse events experienced with right-to-try drug use under a proposed FDA rule, leading critics to once again raise safety concerns with the pathway for accessing experimental medicines. The agency will not help patients or companies determine whether drugs qualify for right-to-try.

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.

Next Step After 'Right To Try'? Senate Hearing Includes Call To Reopen Orphan Drug Act

Trump Administration’s successful campaign to pass “Right to Try” legislation may be emboldening advocates to push for other policies that will loosen FDA regulatory requirements on rare disease drug development.

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