• 888-778-6481

    FDA budget gets 5% bump in 2016 and ban on gene editing

    One of the biggest winners in the 2016 omnibus spending bill is the U.S. Food and Drug Administration (FDA). The bill provides the agency with about $2.72 billion, not including $1.96 billion in anticipated user fees collected from companies applying for FDA review. The number is just shy of the president’s $2.75 billion request, and represents an increase of nearly 5% over 2015 levels. The bump is “pretty darned good in this environment,” says Steven Grossman, deputy executive director of the Alliance for a Stronger FDA.
    The agency will also receive $2.4 million for its initial contribution to the new government-wide Precision Medicine Initiative aimed at ensuring the accuracy of genetic tests. The agency just launched precisionFDA, a web platform for diagnostics companies, researchers, and healthcare providers to validate genetic tests against reference materials and share their results.
    In line with the views of most biomedical researchers, lawmakers struck a note of caution about the implications of new gene editing techniques that make heritable changes to human embryos. The bill forbids FDA from using funds in the bill to evaluate—or even “acknowledge the receipt of”—submissions for therapies based on research that modifies embryos. Such research is not currently eligible for NIH funding, and is still years from producing therapies that regulators would have to green light before they could be tested in humans.