FDA Enforcement Trends: What to Expect in the Next Three to Five Years


For those who follow FDA enforcement trends, 2015 has been a complicated year. On the one hand, the Amarin decision has challenged FDA’s historical regulation of medical product promotion, and the agency has adopted some flexibility regarding the development of mobile medical applications and laboratory developed tests (LDTs). On the other, the Department of Justice recently announced its renewed focus on assessing executive culpability for corporate violations, and a federal judge just handed down a substantial jail sentence for an FDA-related crime. In our view, this dichotomy is now more the rule than exception, and we expect FDA to continue its practice of enforcing the law energetically against certain actors while it simultaneously develops increasingly balanced positions on discrete health policy issues. We expect the next three to five years to be very active from an enforcement perspective and anticipate upward trends in the number of GMP regulatory enforcement actions, qui tams, track-and-trace violations, executives named as defendants, and oversight of post-market safety signals and related reporting issues (AERs and MDRs).
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FDA Expedited Access Pathway – Smoothing the Route to Market for Innovative Medical Devices


In April of 2015 the Food and Drug Administration (FDA) issued a final guidance document describing the Agency’s newest program for innovative therapies. The document, Guidance for Industry and Food and Drug Administration Staff: Expedited Access for Premarket Approval and De Novo Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions (“EAP Guidance”) describes a program intended to expedite the development, assessment and FDA review of innovative medical devices intended to treat life threatening or debilitating diseases.
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Put “Spring Cleaning” on Your Summer Compliance To-Do List


Summer can be the time of laid back, restful behavior, but it is also a perfect time to assess your half-year of progress and clean up what needs to be done for the remainder of 2015. While housekeeping can be a chore, breaking the tasks into small steps done on a regular basis can keep you on top of your cleaning game. With ever-closer FDA scrutiny and new guidelines in effect, the cost of drug development has never been higher. According to a recent study by the Tufts Center for the Study of Drug Development, the cost of new prescription medication development through market approval is $2.6 billion. Contract manufacturing organizations (CMO) can polish their activities in the following compliance areas to make sure they pass that white-glove test and keep costs to a minimum:
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