Stacy Cline Amin spoke to Bloomberg Law for an article looking at how Robert Califf, in his return as commissioner of the Food and Drug Administration (FDA), will likely prioritize improving drug competition and boosting patient access to innovative treatments.
According to Stacy, the increased attention to the FDA's role in drug pricing marks a change from previous years.
"One of the things that has been interesting in this administration is seeing FDA wade into discussions that it has traditionally tried very hard to not be involved in, like patent law discussions," Stacy said. She added that the FDA has typically avoided discussions on drugmaker patent practices, such as filing patents for the sole purpose of weeding out competitors.
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