FDA Policy/General

Take Food Regulation from FDA: Researchers

Two George Mason University Mercatus Center researchers say FDA’s food regulation responsibilities should be given to the Agriculture Department or some other entity to focus FDA efforts just on regulating medical products. In an online opinion column for The Hill, the researchers suggest that FDA has failed dramatically in its efforts to cope with the Covid-19 public health emergency.

“Its regulations and inflexible procedures have prevented businesses and entrepreneurs from stepping in and providing critical supplies like hand sanitizer and facemasks,” the authors write. “Its highly restrictive virus testing processes have been a major barrier to the creation of new Covid-19 tests that could help detect outbreaks and save lives.”

The researchers say part of the problem may be that FDA is too big — in terms of bureaucracy if not budget. “When organizations grow,” they write, “they rely more on strict rules and procedures. Over time, this causes them to become less and less flexible and adaptable. The problem is compounded by the fact that FDA is charged with regulating both food and drugs, two drastically different things.”

The article suggests taking the best and most essential food safety responsibilities from FDA and consolidating them with the Agriculture Department. “Food safety experts can assess which regulations are needed from each agency, which ones are counterproductive, and how they should fit together,” the authors say. “Meanwhile, removing the food portion of FDA would allow the agency to clarify its mission and better focus on drugs.”

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