Life Sciences Legal Update

Recent Posts from Life Sciences Legal Update

• FDA Discusses Social Media Advertising Regulation for the Life Sciences Industry

  This post was written by Dana Blanton. On November 12 and 13, 2009, the FDA hosted public hearings to vet the potential need for regulation of prescription pharmaceutical and medical device marketing on social media…

• Health Care Facilities Targeted in Wage and Hour Lawsuits

  Across the country, plaintiffs’ attorneys are targeting health care facilities over their alleged failure to comply with meal break rules. These suits claim that employers have automatically deducted 30 to 60 minutes of time for…

• Health Reform Update: Focus On Prescription Drug Price Regulation

  While Congress continues to debate the “big picture” issues of broad-scale health care reform, pending bills in both the House of Representatives and Senate contain proposals to amend federal prescription drug price regulation programs such…

• Ten Data Security Questions Faced by Every Company

  Privacy and data security are hot topics for everyone doing business in today's rapidly developing climate, and no less for those in life science and health-related industries. With new federal statutes, new regulations from HHS…

• Another Postponement of FTC's Red Flags Rule

  On October 30, 2009 the Federal Trade Commission (FTC) issued a News Release announcing that it is granting industries under the FTC's jurisdiction an additional 7 months (i.e., until June 1, 2010) to develop and…

• HHS Rule Implements HITECH Act Changes to HIPAA Enforcement

  On Friday, October 30, 2009, the U.S. Department of Health and Human Services ("HHS") published an interim final rule and request for comments that implements certain HIPAA enforcement changes made pursuant to the HITECH Act. Consistent…

• Sebelius Issues Section 1135 Waiver

  This post was written by Kevin Madagan and Paul Sheives. On October 24, 2009, President Obama signed a proclamation declaring the 2009 H1N1 influenza pandemic a National Emergency to facilitate the nations ability to respond…

• Third Circuit Holds That MDL Judges Can't Reverse Pre-Transfer Orders Absent Extraordinary Circumstances

  This post written by Eric Buhr. In a precedential decision issued Thursday, In Re: Pharmacy Benefit Managers Antitrust Litigation (MDL 1782), the U.S. Court of Appeals for the Third Circuit reinstated a district court order compelling…

• New HHS Regulations Impose Federal Security Breach Notification Requirements

  The recently enacted Health Information Technology for Economic and Clinical Health (“HITECH”) Act, which amends various aspects of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), including the associated Privacy and Security Rules,…

• U.S. Department of Homeland Security Mandates Use of E-Verify for All Employees Performing Work on Government Contracts

  This post was written by Irene M. Recio and Lorraine M. Campos. E-Verify is a free internet-based program operated by the U.S. Department of Homeland Security, U.S. Citizenship and Immigration Services ("CIS") to allow employers…