The Hottest Topics for Health Attorneys in 2022’s Homestretch
Law360
Law360
Stacy Amin spoke to Law360 about the upcoming issues the healthcare and life sciences industries need to watch in the closing months of 2022.
Stacy noted that Senator Richard Burr, ranking member of the Senate health committee, has argued against the federal government’s fiscal budget, which includes billions of dollars in fees that fund FDA approvals and inspections for drugs and devices.
She said “one of the biggest sticking points” for Burr appears to be a rider that would essentially overrule the Eleventh Circuit’s controversial decision in Catalyst Pharmaceuticals v. Becerra. The decision dramatically widened market exclusivity for so-called orphan drugs that treat rare diseases.
“I understand his concern about tacking such an important piece of legislation onto the bill at the last minute,” Stacy said. “But I think his concern is misplaced in this instance. The Catalyst fix would clarify the interpretation of orphan exclusivity that Congress meant when it originally enacted the provision.”
“These are three huge industries that are largely unregulated today,” Stacy said. “It’s important that Congress get the balance right in regulating these industries, but if they don’t attach to the user fee [legislation], it might be years or decades before we see badly needed reforms.”
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