Tag: supreme
UPDATE: Second Circuit Rejects Government’s Off-Label Enforcement Approach
UPDATE TO EARLIER POST:
On Wednesday, January 23, Food and Drug Administration officials said the government will not appeal the decision in the United States v. Caronia, No. 09-5006-cr (2d Cir. Dec. 3, 2012). The FDA decided against asking the court to rehear the case, and will not appeal to the Supreme Court. The FDA stated that it “does not believe that the Caronia decision will significantly affect the agency’s enforcement of the drug misbranding provisions of the Food, Drug & Cosmetic Act.”
Read Jesse Witten’s recent post on this case here.
Drinker Biddle’s Health Government Relations Team Hosting: Health Care Reform & Supreme Court Review Webinar
From Capitol Health Record: By the end of June, it is expected the Supreme Court will rule on the constitutionality of the Patient Protection and Affordable Care Act. Join us to gain a better understanding of the four questions before the Court and the political, legislative and regulatory implications of the Court’s pending decisions. Our panel also will discuss the different possible outcomes of the Court’s deliberations and their respective political and policy ramifications. Regardless of where you work or who you represent, this presentation will provide important insight and analysis to help inform your business, association, legislative and/or regulatory planning.
Register now to participate in this webinar, featuring the DBR Health Government Relations team!
7th Circuit Finds Pharma Sales Reps are Exempt Employees on Eve of Anticipated Ruling from Supreme Court
In a significant opinion for the pharmaceutical industry, the U.S. Court of Appeals for the Seventh Circuit found this week that pharmaceutical sales representatives at Eli Lilly and Abbott Laboratories are exempt from overtime under the administrative employee exemption in the Fair Labor Standards Act (“FLSA”). That exemption applies to employees who 1) primarily perform nonmanual work directly related to the business of the employer, and 2) exercise discretion and independent judgment with respect to matters of significance to the business of the employer.
The Seventh Circuit, rejecting the position of the Department of Labor as amicus curiae, found that the administrative exemption applied because the substantial work of the sales representatives is to prepare for, make, and document their sales calls to physicians to persuade them to prescribe the companies’ products, and that they exercise “significant discretion in the manner and mode of delivery of … Read More »