FDA Policy/General

House Appropriators Approve $41 million Boost

A House appropriations subcommittee has approved by voice vote a bill that includes an additional $41 million for FDA in fiscal year 2021. The vote advances FDA’s budget totaling $3.212 billion in discretionary funding. Total funding for the agency, which includes user fees, is $5.99 billion. “Within this total, the committee provides targeted increases for medical product and food safety activities, including new initiatives to advance new influenza vaccine manufacturing technologies, support for a new, crosscutting activity enhancing food and medical product safety and includes funding to develop a framework for regulating CBD products,” a subcommittee release says.

Additionally, the spending bill includes funding to advance FDA’s efforts to respond to foodborne illness outbreaks and increase the safety and cybersecurity of medical devices, the subcommittee says. The bill also appropriates $70 million to accelerate medical product development as authorized in the 21st Century Cures Act.

During the mark-up, Rosa DeLauro (D-CT) took the opportunity to criticize FDA commissioner Stephen Hahn’s appearance on CNN Sunday (7/5) where he refused to refute president Trump’s false claim about the severity of the coronavirus. Over the holiday weekend, Trump claimed that 99% of cases were “totally harmless.” However, many health experts estimate that 20% of those diagnosed with Covid-19 progress to severe disease, including pneumonia and respiratory failure.

Asked to correct the president’s claim, Hahn told CNN, “I’m not going to get into who’s right and who’s wrong.” But this is exactly the mission of FDA, DeLauro said in opening remarks. “The mandate of the agency is to distinguish between right and wrong, especially as it relates to misleading claims about this virus,” she said at the hearing. “So, as we invest in the FDA’s mission, I look forward to working with others on the subcommittee and the full committee to make sure the agency provides the most accurate information to the public.”

Now that the subcommittee has approved the measure, the bill next heads to the full committee for markup.

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