FDA Policy/General

POGO Says HHS Gags Employees

The Project on Government Oversight (POGO) says an HHS 5/3 staff memo “gags employees from speaking with Congress and violates the Whistleblower Protection Enhancement Act of 2012.” The memo was released by Sen. Charles Grassley (R-IA) and Rep. Jason Chaffetz (R-UT). It says that any communication with members of Congress should not occur without prior consultation with the HHS Office of the Assistant Secretary for Legislation, including requests for calls, meetings, briefings, technical assistance, policy development, hearings, oversight, detailees, etc.

POGO says the memo fails to give HHS employees language required by the whistleblower protection act that mandates agencies include language in non-disclosure agreements and policies that inform employees that they have whistleblower rights. “Without this language,” it says, “federal employees may believe they cannot lawfully communicate with Congress as individuals and as whistleblowers.”

In February, Grassley, Chaffetz, and Rep Mark Meadows (R-NC) raised similar concerns about Trump administration communications to workers at the Environmental Protection Agency and the Agriculture Department.

“The Trump administration cannot unilaterally disregard laws protecting federal employees’ right to communicate with Congress,” says POGO director of investigations Nick Schwellenbach. “Agencies cannot lawfully muzzle employees to keep Congress in the dark on wrongdoing.”

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