FDA Policy/General

2 House Senior Democrats Challenge Trump Gag Orders

Two ranking Democrats on the House Energy and Commerce Committee and the Oversight and Government Reform Committee are pushing back on White House gag orders reportedly dictated to HHS and other departments. Reps. Frank Pallone, Jr. (D-NJ) and Elijah E. Cummings (D-MD) sent a letter 1/26 to White House counsel Donald McGahn II requesting that the Trump Administration “take immediate action to remedy gag orders on federal employees that appear to violate multiple federal laws, including the Whistleblower Protection Enhancement Act, which Congress passed unanimously in 2012 to protect federal employees who report waste, fraud, and abuse.”

“For more than a century, Congress has protected the rights of federal employees to communicate with Congress about waste, fraud, and abuse in the Executive Branch,” the ranking members wrote. “We urge you to immediately rescind all policies on employee communications that do not comply with the Whistleblower Protection Enhancement Act and other federal statutes... In addition, because of the magnitude of these problematic directives, we request that the president issue an official statement making clear to all federal employees that they have the right to communicate with Congress and that he and his Administration will not silence or retaliate against whistleblowers.”

The letter referenced multiple reports that the Trump Administration issued restrictions at several agencies on employee communications including, communications with Congress. For example, a memo issued at HHS on Trump’s first day in office reportedly prohibits employees from communicating with Congress, it noted.

The lawmakers letter also cited a memo issued 1/25 by the Office of Special Counsel, which is charged with protecting whistleblower rights for federal employees, on its enforcement of the anti-gag order provision in the Whistleblower Protection Enhancement Act, under which agencies are prohibited from imposing “nondisclosure agreements and policies that fail to include required language that informs employees that their statutory right to blow the whistle supersedes the terms and conditions of the nondisclosure agreement or policy.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome