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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FTC May Go After Pharma Bundling, Rebates, Patent Processes With Reactivation of Section 5
Agency restores long dormant enforcement of section of FTC Act prohibiting businesses from using ‘unfair methods of competition,’ expanding types of corporate behavior subject to enforcement action.
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.
Bills To Speed Generic Entry Once Again Clear Senate Judiciary Committee
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.