Biologics

Law Professors Voice FDA Concerns

Three law professors from different U.S. universities are joining the chorus of those expressing concern that FDA is under too much political pressure to make positive decisions on products to help resolve the Covid-19 pandemic. In a piece distributed online to be used as an op-ed, the three say they have “examined the regulatory posture of FDA since the beginning of the outbreak [and] have studied how FDA’s decisions have varied within the external pressures that it has faced, comparing it to past emergency decision making by the agency. We believe that this episode (an emergency use authorization (EUA) for convalescent plasma that included misstatement of clinical data by FDA commissioner Stephen Hahn) is symptomatic of a larger problem, and we worry that FDA’s repeated departure from evidence-based standards and long-tested and proved procedures will soon translate into a poorly considered authorization of Covid-19 vaccines.”

The article says that a properly issued EUA is balanced by legal and scientific checks. The professors say the law directs the agency to assess whether a specific product considered for a EUA “may be effective” in light of the “totality of scientific evidence available.” FDA also must determine whether the product’s potential benefits outweigh the known and potential risks and that there is no adequate, approved, and available alternative.

The authors conclude that there should be absolutely no link between the 11/3 presidential election and the vaccine regulatory process. They say concerns have been voiced that there might be a push for a rushed authorization of a Covid-19 vaccine if President Trump needs a boost in the polls. The EUA of convalescent plasma and in particular the misrepresentation of data at the FDA level have fueled the concerns, they write.

The article also notes that vaccine EUAs can be problematic because the agency would have to make a risk/benefit assessment based on limited data. “Because of the nature of vaccines,” it says, “many experts have argued that this pathway is too risky for vaccines.”

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