Drugs

SCOTUS Chevron Decision Harms the Public: Coalition

Public Citizen’s Coalition for Sensible Safeguards says the Supreme Court's 6/28 decision that overturned a 40-year-old legal precedent to gut the so-called “Chevron deference” will harm the public. “The court today, once again, sided with big corporations trying to weaken agencies’ ability to issue strong rules to protect the public,” a coalition statement says.

Under Chevron, courts were to acknowledge Congress’ decision to delegate policymaking authority to subject matters at federal agencies, like FDA, the statement says. “These experts, not judges, should make decisions about how best to implement a statute, in light of real-world experience,” it says.

Coalition executive director Rachel Weintraub says the public “expects our government to protect us from dangerous products, polluted air and water, unsafe workplaces, and fraudulent markets. This decision will harm all of us for as long as it stands.”

Public Citizen president Robert Weissman, who is the coalition’s co-chair, says the decision “is a gift to big corporations, making it easier for them to challenge rules to ensure clean air and water, safe workplaces and products, and fair commercial and financial practices. But the decision is no excuse for regulators to stop doing their jobs. They must continue to follow the law and uphold their missions to protect consumers, workers, and our environment.”

The coalition calls on Congress to enact Chevron deference into law by passing the Stop Corporate Capture Act (HR 1507). It describes the bill as a “comprehensive blueprint for modernizing, improving, and strengthening the regulatory system to better protect the public. It would ensure greater public input into regulatory decisions, promote scientific integrity, and restore our government’s ability to deliver results for workers, consumers, public health, and our environment.”

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