An Article by Laura Jungels, VP of Managed Services at Clutch, entitled, “4 Trends Causing Anxiety in Pharmaland ” has been published in Corporate Counsel and featured as a leading story. An excerpt of the article can be found below.
4 Trends Causing Anxiety in Pharmaland
Laura Jungels, Corporate Counsel November 7, 2016
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.
- The Impact of Global Trade Creates Uncertainty
Despite growing opposition from presidential candidates and lawmakers, the Obama administration continues to advance TPP negotiations, which, under current terms, would extend data exclusivity to 12 years for biologics and apply patent linkage protections to biosimilars. These and other provisions could slow the emergence of new generics. Notably, however, presidential candidate Donald Trump has called for measures to increase the presence and competitiveness of international pharmaceuticals in the U.S. market.
The United Kingdom’s recent decision to leave the European Union is expected to upset European pharmaceutical regulation and supervision. The European Medicines Agency (EMA) is likely to relocate its headquarters in the U.K. and its Medicines and Healthcare Products Regulatory Agency (MHRA) is likely to lose its dominance.
- Growing Media Spotlight Results In Increased Supervision
In the United States, an increase in pharmaceutical industry awareness is likely to fast-track certain issues for supervision, investigation, legislation and rulemaking. Pharmaceutical price-gouging made it into congressional hearings and Hillary Clinton’s presidential platform after drawing considerable media and investigatory attention last year.
Additionally, the growing opioid epidemic has opened a legislative and regulatory discussion into pain management as well as the high pricing and limited availability of anti-overdose drugs such as Naloxone.
- Legislation Such as the CREATES Act Gains Traction
Other developing issues, already in the legislative process, promise to alter market and regulatory conditions in the coming years. The Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act would restrict tactics currently employed by branded pharmaceutical providers to delay generic competitors. The legislation is gaining traction in the Senate, which is also expected to take up the 21st Century Cures Act, already approved by the House of Representatives in September. This legislation would dramatically expand funding for the National Institutes of Health (NIH) and streamline the FDA’s approval process.
President Barack Obama’s Precision Medicine Initiative and the National Cancer Moonshot Initiative would also accelerate pharmaceutical innovation. Congress has recently taken aim at the Physician Payments Sunshine Act. The Protect Continuing Physician Education and Patient Care Act would reverse reporting requirements on pharmaceutical providers to disclose payments made to doctors to fund continuing medical education.
These legislative developments could open up industry competition and innovation, but would still represent a dramatic disruption of existing practices and policies.