FDA Policy/General

FDA Leaders’ Financial Ties to Drug Industry Probed

A BMJ investigation says that while FDA says it takes conflicts of interest seriously, “financial entanglements with the drug industry are common among its leaders.” The article discusses current FDA commissioner Robert Califf and former commissioners Lester Crawford, Margaret Hamburg, and Scott Gottlieb.

It notes that when Califf was confirmed, he committed to selling his pharmaceutical stocks and severing financial relationships with biotech companies, including Verily Life Sciences, where he was a senior advisor.

The report indicates that Crawford was sentenced to three years of supervised probation and fined $89,377 for false reports about stocks that he and his wife owned in four FDA-regulated companies.

The Trump administration, the report says, rescinded on his last day in office a requirement that appointees sign an ethics pledge, committing not to lobby the agencies they worked in for five years after public service. Gottlieb, who led FDA for two years under Trump, was nominated to Pfizer’s board shortly after he left the administration.

The article devotes the greatest attention to Hamburg’s situation since she was allowed to hold financial interests in an exclusive hedge fund managed by her husband’s company. It says that a BMJ analysis found the hedge fund consistently invested in FDA-regulated companies during Hamburg’s tenure with the agency.

Public Citizen’s Craig Holman told BMJ that the Office of Governmental Ethics (OGE) should be strengthened. OGE is an independent agency that reviews the financial disclosures of senior executive branch nominees to identify potential conflicts of interest.

“Currently, the agency is small,” he said, “with around 70 employees and is focused on issuing advice, for example, about divestiture, with limited ability to enforce its recommendations.”

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