The US House of Representatives passed a federal “right-to-try” bill [March 21], leaving many Americans wondering what the move could mean for their health and that of their loved ones.
The central question, however, remains: Would a federal right-to-try bill help or hurt some of the country’s most fragile patients?
Right-to-try advocates argue that by bypassing FDA permission, patients can save even more time.
The right-to-try bill would be different from the FDA’s current expanded-access policies, as the current policies require patients to apply for access, [said Starlee Coleman, senior policy adviser at the Goldwater Institute a conservative public policy think tank based in Phoenix that supports right-to-try legislation]. “This law eliminates the application requirements to the FDA,” she said.
Supporters of right-to-try argue that the legislation is needed because most terminal patients are too sick to be selected to participate in clinical trials and it takes too long for promising treatments to be approved.
[Dr. Steven Joffe, professor in medical ethics and health policy at the University of Pennsylvania’s Perelman School of Medicine] argued that the right-to-try approach to providing access to unapproved drugs early in their development could put patients in harm’s way, as patients receiving the drug are often in very fragile health, doctors often lack the information needed to administer the drugs safely, and little may be known about their risks and benefits, he said.
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