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Law360 quotes James C. Shehan in an article discussing the likelihood of an increase in litigation against U.S. Food & Drug Administration (FDA) policies should the Hon. Brett Kavanaugh of the U.S. Court of the Appeals for the District of Columbia Circuit be confirmed to the U.S. Supreme Court. Judge Kavanaugh has criticized the Supreme Court’s Chevron doctrine, which mandates judicial deference to reasonable administrative agency interpretations of ambiguous federal laws, as enabling agencies to “stretch the meaning of statutes.” Shehan predicts that a shift by the Court on Chevron will spark more lawsuits against the FDA. He notes that while Chevron may still inspire judicial deference in cases involving complex scientific matters, any lessening of deference more generally would diminish the FDA’s authority. (subscription required to access article)
Modern Healthcare quotes James C. Shehan, Head of Lowenstein’s FDA Regulatory Practice, on how the FDA’s new Medical Device Safety Action Plan will fill gaps in device regulation and may portend further FDA action in other areas.
Jim Shehan, Head of Lowenstein’s FDA Regulatory Practice, is quoted in Modern Healthcare regarding the security of medical devices pertaining to health systems, noting the lack of absolute security in the electronic world.
Jim Shehan comments in Law360 on the FDA’s 2017 enforcement statistics showing a continued drought of drug promotion enforcement.
Jim Shehan is quoted in Modern Healthcare regarding the FDA's final guidance on 3-D printed medical devices and how it will spur innovation.
In Law360, Jim Shehan opposes proposal from professors to reduce insurance coverage for accelerated approval drugs and cites good safety and effectiveness record of these products.
Jim Shehan comments in Reuters on Trump administration proposals for FDA deregulation.
Jim Shehan comments in Law360 on the deluge of bold policy statements made by the FDA during the final days of the Obama administration.