Drugs

1st Amendment Court Losses ‘Threaten FDA Premarket Approval System’

Continued government losses in lower courts involving First Amendment-related off-label drug marketing cases raise the specter that FDA’s entire pre-market approval regime could be in jeopardy, according to University of Arizona law professor Christopher Robertson. Writing in an Arizona Legal Studies discussion paper, Robertson notes how the U.S. Supreme Court in recent years as “expanded the reach of the First Amendment in many domains – from video games and dog-crush videos to campaign finance and military honors. If the Supreme Court takes an off-label drug marketing case and embraces the same First Amendment logic that is percolating with scholars and in the lower courts, it would allow a drug maker to get FDA approval for any one use that it chose, but then market the drug for every other use, even where safety and efficacy are unknown.”

Robertson has examined First Amendment arguments about speech, truth, prior restraints, discrimination and other core doctrines and finds that if they were valid, they would not be limited to the off-label world. They would undermine FDA’s premarket approval system, he warns. “If the First Amendment protects a right to promote unproven uses, then it does so for their new and old drugs alike,” he writes. “Then, upstart drug makers will be able skip the FDA altogether, proceeding straight to market, just like the snake-oil salesmen that motivated the creation of the FDA in the first place.”

Robertson concludes that because the stakes are high, courts should tread carefully when addressing First Amendment issues because they are likely to “dismantle a key part of the modern regulatory state.”

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