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ACA

Rise in Biosimilars Approvals Leads to Increased Litigation in US

Since the enactment of the Biologics Price Competition and Innovation Act (BPCIA), the Federal Drug Administration (FDA) has approved more than 20 biosimilar products, and, as the market has grown, litigation activity concerning biosimilars has increased rapidly. Signed into law as part of the Affordable Care Act on March 23, 2010, the BPCIA is codified …

  • November 14, 2019
  • Kara Pederson

Mitchell & Mitchell on Health Care and the Trump Agenda, Part 19: Continuing Impact of 2017 “Repeal and Replace” Efforts

This is Part 19 in an ongoing series regarding changes in health care that may take place—and actual changes that do take place—with the Trump administration. The likely implementation issues to be encountered for both potential and actual changes are described, based on detailed methods of analysis. The emphasis is on what these shifts mean …

  • October 10, 2017
  • Alex Cook

Mitchell & Mitchell on Health Care and the Trump Agenda, Part 13: An Opportunity for Attorneys to Help Shape Health Care Policy?

This is Part 13 in an ongoing series regarding changes in health care that may take place—and actual changes that do take place—with the Trump administration. The likely implementation issues to be encountered for both potential and actual changes are described, based on detailed methods of analysis. The emphasis is on what these shifts mean …

  • June 26, 2017
  • Alex Cook

Mitchell & Mitchell on Health Care and the Trump Agenda, Part 12: Flaws in CBO Studies Can Limit Policy Debates and Attorney Actions

This is Part 12 in an ongoing series regarding changes in health care that may take place—and actual changes that do take place—with the Trump administration. The likely implementation issues to be encountered for both potential and actual changes are described, based on detailed methods of analysis. The emphasis is on what these shifts mean …

  • June 14, 2017
  • Alex Cook