In a strong show of bipartisanship, Congress overwhelmingly passed the 21st Century Cures Act, which President Obama signed into law in December 2016.
With promises on transforming aspects of how the FDA regulates drugs and devices, all stakeholders are closely watching the outcomes from the Act. Here are 5 milestones that will define the early phases of implementation.
Within 90 days of the law being signed (i.e. by March 13, 2017) the secretary of the HHS had to:
- Establish a task force to provide guidance on the gaps in knowledge and research for safe and effective therapies for pregnant and lactating women.
- Publish a list of each type of class II device that no longer requires a report to prove safety and effectiveness in the Federal Register.
Within 180 days of the law being signed (i.e. by June 13, 2017):
- FDA Commissioner should develop a plan to issue draft and final guidance documents regarding the use and collection of patient experience data.
- NIH Director should convene a workshop to provide inputs on the inclusion of “appropriate age groups” in clinical research trials.
- HHS secretary must publish a list of reusable device types that are validated in terms of cleaning, sterilization and disinfection.
Given the size of the bill (~1000 pages), there are many more implementation milestones on issues ranging from Medicare, Medicaid to patient privacy protections which will kick in 18 months from signing.
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