Congress’ Next Steps On REMS Abuses: Will Improving FDA-FTC Communication Help?
US FDA has seen little success in ending gaming of the patent process by brand name manufacturers. One problem: the agency’s referrals to FTC on anti-competitive cases appear go into a black box.
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Other sponsors could be using tactics other than REMS abuse to game the system, US FDA Commissioner Scott Gottlieb says.
During bipartisan, but one-sided, hearing about US FDA’s limited authority to ensure generic drug makers can access restricted distribution reference products for bioequivalence testing, one lawmaker wants to know what FTC is doing about the issue.
It’s a classic example of an internal dispute between an FDA review team and agency leadership playing out at an advisory committee forum, except with the highest possible stakes.