Patients often demand experimental drugs that prove ineffective — report
A new paper by a team of FDA officials finds that only about 30% of drugs requested for expanded access go on to be approved by the agency.
“Expanded access provides just that: access. There is no guarantee that the product sought will be effective and/or safe, much less that it will be effective and/or safe for the particular patient,” the authors write.
Background
In recent years, the debate over patient access to unapproved drugs has risen to the national stage. So called “right-to-try” laws, also known as right-to-ask laws, seek to bypass FDA to provide access to unapproved drugs and have been enacted in 37 states. In August, the US Senate passed a bill that would expand right-to-try nationwide, though the House has yet to consider the bill.
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