Cures Act covers vaccines, ACIP, and more
A congressional fact of life is the dangerous “Christmas tree” bill, which passes with so much on it that many things don’t get the scrutiny they deserve.
Thus, the 21st Century Cures Act, signed into law by President Obama on December 13, 2016, is the equivalent of maybe 500 regular-sized pages that modify the US Food and Drug Administration (FDA) drug and device approval process, fund precision medicine and a cancer moon shot, and make numerous changes to Medicare, to name some examples.
In a subtitle on vaccines, the Cures Act calls for a report from the US Department of Health and Human Services on promoting innovation in vaccine development, and it updates the vaccine injury compensation system so that when a pregnant woman receives a covered vaccine, the child in utero will be considered covered by the system. It also has specific mandates for the Advisory Committee on Immunization Practices (ACIP) to, as appropriate, consider a vaccine at its next regularly scheduled meeting after the vaccine is licensed by the FDA. If ACIP does not make a recommendation, it must provide an update on its review.
The law mandates that the Centers for Disease Control and Prevention reviews the ACIP’s recommendation process, “including the identification of any areas for which flexibility . . . is necessary and the reason for flexibility,” and the extent to which the processes used by its work groups are consistent with the other work groups.
Walter A Orenstein, MD, former director of the US Immunization Program and now director of Vaccine Policy and Development at Emory University, Atlanta, Georgia, commented on the provisions, saying, “I think there clearly are some misunderstandings of what the processes are and how we try and make our immunization schedule as effective and safe as it could be.”
The Cures Act also contains major legislation to expand mental health work, including creating the position of assistant secretary for mental health and substance abuse. In addition, it mandates that the National Institutes of Health help create a research network on pediatric rare diseases or birth defects, and it continues the voucher program within the FDA that gives drug sponsors incentives to develop new drugs for rare pediatric diseases.