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BioCommunique Article

How will drug pricing, the FDA’s new Commissioner, and the proposed single payer system in California bring forth challenges and opportunities?

2020: A Glimpse Into the Regulatory Landscape

  • 2020-01-17T20:54:00.000+0000
  • California
  • Author: Jimmy Jackson

2020 will inherit many industry challenges, and it will also bring new ones. From drug pricing to a new Food and Drug Administration (FDA) Commissioner, a wave of policies and reforms will impact California’s life sciences this year.

In late 2019, the House of Representative passed major drug pricing legislation imposing price controls on drugs marketed in the U.S. Because it was a partisan bill that gained very little Republican support, it remains unclear if both parties can collaborate on a comprehensive drug pricing package. However, we could see action on smaller bills that have gained bipartisan support – some of which passed on the House floor.

Drug pricing aside, a healthcare priority for Congress in 2020 will likely be surprise billing. Biocom will also be following the FDA with the confirmation of its new Commissioner, Dr. Stephen Hahn, who announced one of his first priorities will be implementing pathways for the importation of certain drugs originally intended for foreign markets. Other issues the FDA is prioritizing include using real-world data when approving new medicines, the opioid crisis and the upcoming reauthorization of the Prescription Drug User Fee Act (PDUFA).

In Sacramento, we will likely face similar challenges as Governor Gavin Newsom attempts to move California closer to a single payer system—including proposing that the state negotiate drug pricing on behalf of itself and other public and private payors, consider lowest available international pricing, and develop its own generic drug line. We also expect there may be state efforts to encourage foreign drug reimportation despite the public health risk. Finally, consumer privacy advocates will likely be active again, and Biocom will ensure their proposals include no unintended industry consequences.

In San Francisco, we continue to participate in conversations regarding a potential business tax overhaul in 2020. Biocom is also working with the City of South San Francisco on a proposal for a Community Facility District to fund transportation and transit improvements.

Biocom was strongly involved in 2019 when the Los Angeles County Board of Supervisors passed a Bioscience Overlay Zone, streamlining permitting processes for life science developments. Biocom assisted crafting the measure and will continue with its implementation, as well as potential similar zones in cities throughout Los Angeles County. In the City of Los Angeles, we are working with the Chamber on the implementation of Jobs and Economic Development Incentive (JEDI) Zones specific to life science.

Biocom is participating on the City of San Diego’s University Community Plan Update Committee, helping to dictate development of San Diego’s life science hub for the next 20 years. Biocom will also continue its leadership at the City of San Diego, pursuing land use changes to make it easier to build housing, reform the community planning process and examine changes to life science development projects—all of which Biocom will have a voice in.

As with anything, the year ahead brings a mixture of challenges and opportunities. But amidst the predictions, one thing remains clear: California’s life sciences remain stronger than ever.