Biologics

FDA/Moderna ‘Revolving Door’ Analyzed

A BMJ investigation by senior editor Peter Doshi explores the “revolving door” between FDA and its regulated industries as shown in the case of two senior CBER Office of Vaccine Research and Review officials who now work for Moderna. One of the officials, Doran Fink, had an active public government role in the development of the Covid-19 vaccines, including announcing in mid-2020 FDA’s expectations for any Covid vaccine the agency would consider authorizing and participating in the decision to license the Pfizer/BioNTech and Moderna vaccines, the report says.

Doshi says social media indicates that Fink finished at FDA at the end of 2020 and two months later was working for Moderna, heading the translational medicine and early clinical development program in infectious diseases. The article identifies the second FDAer Doshi says he found at Moderna as former CBER medical officer Jaya Goswami. She reportedly has been involved in Moderna’s efforts to bring to market an mRNA vaccine against respiratory syncytial virus.

Concern about a revolving door between government and the private sector has persisted for decades, he writes, with public confidence in the integrity of government decisions at issue.

The article quotes Public Citizen government affairs lobbyist Craig Holman saying that those in the public sector “are expected to serve the public interest” and there must be safeguards to ensure they do serve the public interest.

FDA press officer Jeremy Kahn told BMJ FDA has “more enhanced ethics restrictions than most other federal agencies. FDA takes seriously its obligation to help ensure that decisions made and actions taken, by the agency and its employees, are not, nor appear to be, tainted by any question of conflict of interest.”

However, Doshi writes that FDA keeps no records on where employees go after they leave government service, and does not require employees to undergo an approval or clearance process before taking an industry job.

Employees are required to adhere to post-government employment guidance restrictions that include a permanent ban on “switching sides,” the report says, defined as a lifetime ban on communicating to or appearing before the government on behalf of their new employer or anyone else regarding specific party matters in which they participated personally and substantially during their entire government service.

According to Public Citizen’s Holman, the revolving door “is particularly abusive in government agencies that have a huge flood of money going in. That’s a big problem with FDA, especially with the pandemic and Operation Warp Speed.” He says the agency could legally prohibit its employees from working for companies they had regulated and those entering the agency could be required to sign an ethics pledge saying they will not take any official actions that affect their former employers or clients.

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

Read more

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