Fair Remedy Or Illegal Penalty? FDA Disgorgement Authority Questioned
This article was originally published in The Gray Sheet
Executive Summary
Congress should examine whether FDA has the authority to seek disgorgement and restitution in enforcement actions, Hyman, Phelps & McNamara principal John Fleder said Sept. 22
You may also be interested in...
Abbott's AFP, CA 125 Cancer Tests Unaffected By Consent Decree
Abbott Laboratories' AFP and CA 125 diagnostic cancer tests are among the diagnostic products deemed "medically necessary" by FDA and will continue to be made available under the company's Nov. 2 consent decree with the agency.
California Bill To Age-Restrict Sales Of Diet Pills Further Along Than Other States’ Legislation
CA, MA and NJ legislatures remain in session with bills active proposing regulations similar to NY law effective 22 April requiring retailers, including online, to ask for proof of age when customers buying consumer health products containing ingredients labeled or promoted for weight loss and bodybuilding benefits appear younger than 18.
CRN Has Standing For Steep Hill To Climb Challenging New York's Age-Restricted Sales
Federal judge finds “misreading of the legislation” in CRN’s argument that state “restricts access based purely on what has been said about the product or its ingredients.” But standing to challenge “means that only CRN is positioned right now to go before the court on behalf of industry,” says CEO Steve Mister.