A bipartisan bill aimed at helping terminally ill patients gain access to experimental medicines would leave intact the controversial role of the Food and Drug Administration, a notion that will likely upset backers of the so-called right-to-try movement.
The draft legislation, which is being developed with help from the FDA, also includes a provision that seeks to reassure anxious drug makers about making their treatments available, but to what extent this move makes the effort easier to forge a compromise is uncertain.
“Basically, this is being designed to make the existing program easier to accomplish and encourage more companies to provide experimental medicines and larger safety studies,” explained one source familiar with the effort, who stressed the continued political jockeying may alter the language and, possibly, the intent of the bill.
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Ah, an interesting point of view – “we don’t believe the government should have a role in that decision-making process once a drug is determined to be safe enough to give to people in human trials,” said Starlee Coleman, a spokeswoman for the Goldwater Institute” – but there is a true difference between safe enough for trials and ‘safe and effective.’
Trials do surprise, don’t they? I will demure from providing examples.