Biologics

Vaccine Czar May Have Conflicts of Interest: Advocacy Groups

Two consumer advocacy groups — Public Citizen and Lower Drug Prices Now — say that Trump administration coronavirus “vaccine czar” Moncef Slaoui should be classified as a special government employee and thus subject to the conflict of interest code and disclosure requirements. A complaint filed with the HHS Inspector General and the Office of Government Ethics says Slaoui, who has been designated Operation Warp Speed chief scientist and co-leader, was brought in as a private contractor who is exempt from the conflict of interest and transparency requirements that apply to government employees.

“Slaoui is a venture capitalist in the pharmaceutical industry who personally stands to make a fortune from determining winners and losers in the race to develop a vaccine, yet he is exempt from ethics laws that prevent self-dealing,” says Public Citizen government affairs lobbyist Craig Holman. “It is deeply troubling that Trump appointed a pharmaceutical executive and private contractor to help award these massive and critical government contracts.”

In a news release, Public Citizen says that as Slaoui started in his position it became known that he was a major shareholder in Moderna, a company that received $483 million from federal agencies to develop a coronavirus vaccine. A surge in the company’s stock following reports of promising early results in a vaccine clinical trial increased his stock value by $2.4 million, it says. While he has since sold those holdings, the release says, it is not clear what other conflicts of interest remain in his portfolio since there is no requirement that he disclose them. It is known that he retains $10 million in GlaxoSmithKline stock and is a partner in Medicxi, which invests in biotech companies, some of which also are engaged in developing Covid-19 medicines.

“There is far too much at stake, in terms of both the public’s health and the scope of public expenditures in response to the pandemic, to allow any person, including Moncef Slaoui, to assume a leadership position in the war against the pandemic without complying to the conflict of interest code and disclosure requirements,” the complaint concludes.

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