Post-Election Analysis: Healthcare and Pharmaceutical/Medical Device Regulation

With the reelection of President Obama, the healthcare and Food and Drug Administration (FDA) regulatory agenda in the coming year is beginning to come into focus. In particular, although the future of the Affordable Care Act (ACA) framework is now assured, the complex task of implementation - and inevitable efforts to modify aspects of the law - lie ahead. FDA is faced with implementation of the FDA Safety and Innovation Act (FDASIA) and the biosimilars framework, as well as an intense focus on drug compounding. The following is an overview of critical issues and developments that we expect will be important for our clients in the coming year.