Shire's Citizen Petitions Too Old For FTC Action; Door Left Open For Amended Suit
Court tosses FTC complaint alleging Shire used the citizen petition process to maintain a monopoly on Vancocin, says agency did not show company was 'about to violate' the law.
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FDA Slams Citizen Petition: Harsh Language, FTC Referral Suggest Tougher Stance On ANDA Delay Tactics
While the FTC referral is not unique, this seems the first time US FDA has cited intent to delay generic approval as a ground for denying a citizen petition. With Califf's confirmation hearing suggesting some bipartisan consensus on the issue, FDA might soon find itself with new powers.
Legislation to prevent pay-for-delay deals, product hopping and sham citizen petitions, and to require the FTC to study the role of pharmacy benefit managers in the drug supply chain get unanimous committee vote. They may have a good shot at passage given recent actions by President Biden and the FTC, and bipartisan interest in drug pricing.
High court’s decision that FTC lacks authority to seek monetary recovery in litigation is boon for drug makers who have been subject to hefty payouts in reverse settlement and other cases brought by the commission.