All posts by Sarah K. diFrancesca

Nevada Enacts Transparency Bill Targeting Diabetes Drug Price Increases, Sales Representatives, PBMs, Nonprofit Organizations

As we discussed last week, Nevada’s Governor has signed into law SB 539, which provides sweeping transparency legislation related to several aspects of the pharmaceutical industry. Nevada joins several other states in adopting legislation aimed at addressing pharmaceutical price increases and other recent industry concerns. Diabetes Drug Pricing Reports February […]

FDA Solicits Comments Regarding Two New Studies Related to Drug Promotion

The U.S. Food and Drug Administration (FDA) published two Federal Register notices today announcing its intent to study different aspects of drug promotion. In Docket No. FDA-2017-N-1315, the FDA solicited comments regarding its planned research titled, “Experimental Study on Risk Information Amount and Location in Direct-to-Consumer Print Ads.” The FDA explained that direct-to-consumer […]

OIG and HCCA Release Compliance Program Effectiveness Resource Guide

On March 27, 2017, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) and the Health Care Compliance Association (HCCA) released Measuring Compliance Program Effectiveness: A Resource Guide (Guide). The Guide is the joint work product of a group of 40 compliance professionals and OIG staff […]

Comments to Draft Chicago Pharmaceutical Sales Representative License Rules Due April 2, 2017

As previously discussed, pharmaceutical sales representatives that conduct business in the City of Chicago will need to be licensed as of July 1, 2017. The Commissioner of the Chicago Department of Public Health (CDPH) and the Commissioner of the Chicago Department of Business Affairs and Consumer Protection (BACP) recently released […]

FDA Delays “Intended Use” Final Rule until March 2018

Late last week, the U.S. Food and Drug Administration (FDA) announced that it was once again delaying implementation of the final rule issued January 9, 2017 related to amendments to its regulations regarding intended use (Final Rule). This implementation delay follows a Petition to Stay and for Reconsideration (Petition) filed February 8, […]

Enforcement Trend: Patient Assistance Programs

Multiple pharmaceutical companies have disclosed the receipt of subpoenas from various U.S. Attorney’s offices, including Massachusetts and the Southern District of New York, related to the companies’ patient assistance programs. Patient assistance programs also have been the subject of recent Congressional inquiries related generally to the increasing price of certain […]

OIG Issues Final Rule Re: Exclusion Authority

The Final Rule related to the Health and Human Services Office of Inspector General’s (OIG) exclusion authority pursuant to the Social Security Act (the Act), as amended by the Affordable Care Act (ACA) and the Medicare Prescription Drug, Improvement and Modernization Act of 2003 (MMA), was released last week. The Proposed […]