The pharmaceutical industry is undergoing dramatic changes in its market and regulatory environments in the United States and abroad. While the Food and Drug Administration has been slow to finalize several key rulemakings, the industry is drawing more attention from Congress and the media, as issues such as the Trans-Pacific Partnership (TPP) and the opioid epidemic have come into the spotlight. These public debates are likely to guide legislative and regulatory agendas for the remainder of this year and throughout next year.
The impending presidential election also brings a high degree of uncertainty, as the Obama administration has been the primary driver of industry policy in recent years. As we reach the final stages of election fever, we’ve taken stock of four key drivers of uncertainty in the pharmaceutical market.
