E&C reopens the Orphan Drug Act … sort of
The Energy & Commerce Committee will hold a hearing Wednesday on a slew of food and drug safety bills, but one bill stands out: the Fairness in Orphan Drug Exclusivity Act. The bill would crack down on the so-called “non-profitability” loophole that gives drug makers Orphan Drug status when they can prove they won’t recoup their costs.
That sounds very bad for drug makers, but it’s actually meant to deal with one drug maker in particular: Indivior, which has used the Orphan Drug Act to block lower cost competitors to its opioid-use disorder treatments. The change has even garnered the support of the National Organization for Rare Disorders, the group that has been the unabashed guardians of the Orphan Drug Act since its inception in 1983.
"We need to ensure that the incentives provided by the Orphan Drug Act are used to foster critically necessary drug development for rare diseases,” said Rachel Sher, group’s VP for policy and regulatory affairs, who added that the group supports the intent of the bill.
That sounds very bad for drug makers, but it’s actually meant to deal with one drug maker in particular: Indivior, which has used the Orphan Drug Act to block lower cost competitors to its opioid-use disorder treatments. The change has even garnered the support of the National Organization for Rare Disorders, the group that has been the unabashed guardians of the Orphan Drug Act since its inception in 1983.
"We need to ensure that the incentives provided by the Orphan Drug Act are used to foster critically necessary drug development for rare diseases,” said Rachel Sher, group’s VP for policy and regulatory affairs, who added that the group supports the intent of the bill.
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