Drugs

Avorn Nixes Loosened Drug Communication

Harvard Medical School professor Jerry Avorn raises objections to the loosening of First Amendment controls on what drug manufacturers are permitted to say about their products. Writing in a Health Affairs blog post, he says the “real issue is whether we as a society feel that there is something special about human illness and its treatment that warrants a different legal status than promotional statements made about refrigerators.”

He notes that traditionally, communication about medications has been granted a privileged status different from that accorded to other forms of communications because consumers and even health professionals are not able to easily acquire all the information they need to make informed decisions. But, he says, “large teams of FDA scientists with expertise in pharmacology, clinical trials, epidemiology, statistics, and several other disciplines take six to 10 months to review the massive dossiers submitted by manufacturers to win drug approval. The idea that unfettered ‘commercial free speech’ would make it possible for prescribers to come up with equally useful determinations on their own is simply implausible.”

Avorn acknowledges that overtly fraudulent statements still will not be permitted if drug promotional claims are in a class of commercial speech protected by the First Amendment, but says that a study used in promotional materials could be inaccurate or misleading in many ways without being overtly fraudulent.

“As convinced as I am about this from the perspective of a clinician and drug researcher,” he concludes, “I fear that I will be on the losing side of this battle. The rampant forces of commercial free speech zealotry that are working in the service of corporate empowerment are likely to win this battle. Paradoxically, patients’ rights to the best possible care will be diminished in the process.”

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