FDA Policy/General

Bill to Restrict Revolving Door When FDAers Depart

Senator J.D. Vance (R-OH) and House Representative Debbie Lesko (R-AZ) have introduced the Fixing Administrations Unethical Corrupt Influence Act (FAUCI Act) to prevent top federal health officials at FDA, CDC and NIH from cashing in on the industries they regulate after leaving their respective agencies.

“This legislation will shut the revolving door between big pharma and federal agencies tasked with protecting the American people,” Vance said in release. “It would go a long way in restoring trust in our government.” Lesko added: “My bill seeks to rebuild trust and transparency of this vital component of our nation, holding public servants to higher standards when they leave government.”

The bill would impose new ethics rules on federal employees at key health agencies, such as:

An eight-year prohibition on former top officials serving as board members or officers at drug, biologic product, or medical device companies after leaving government.
A ban on former federal employees who approved product applications from profiting from those products. Offenders could face a civil penalty of $250,000 and up to five years in prison.
Restrictions on patenting drugs, biologics or devices invented during or outside the course of an individual’s federal employment, and requirements for disclosure of ownership or interest in such patents within specified periods.
Disclosure requirements for government officials and their spouses for any ownership stakes in patents of covered products.

To view the full text of the FAUCI Act, click here.

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