Drugs

Lawmakers Consider Easing Off-label Promotion: Report

Congress and state legislatures may be where new efforts are made to ease FDA restrictions on off-label promotion of drugs, according to an open-source PLOS Medicine report by Harvard Medical School’s Michael Sinha and Arnold Kesselheim. They cite the 2012 case U.S. v. Caronia in which a divided 2^nd Circuit Court of Appeals extended protection for “commercial speech” under the First Amendment to off-label marketing statements made by a drug company sales representative. The court said that manufacturers could engage in off-label promotion if it was “truthful and non-misleading,” a standard that the authors say is “far less rigorous than FDA’s current standards for determining a drug’s efficacy and safety for a particular indication.”

Since Caronia applies only within the 2^nd Circuit, the article says, FDA has continued to enforce its existing rules on manufacturer promotion, although it has added additional company safe harbors.

“In the meantime,” the authors say, “state and federal legislators have seized on the Caronia decision to propose statutory changes that would give wide latitude to manufacturers engaging in off-label promotion.” They review changes under the 21^st Century Cures Act and in a law approved in Arizona, as well as measures introduced in the U.S. House of Representatives to extend the permitted range of off-label promotion.

“Buoyed by a narrow victory in one appeals court,” Sinha and Kesselheim conclude, “advocates have turned to state and federal legislatures to unravel current FDA rules relating to off-label promotion. But these rules are essential for the ability of FDA to fulfill its public health mission by defining what uses of drugs have benefits that outweigh their risks versus those that lack sufficient evidence to warrant such use. These distinctions are crucial for individual physicians, who do not have the time or expertise to perform the same critical data evaluation conducted by the scores of highly trained scientists at FDA, and for patients, who could be exposed to more non-evidence-based and potentially dangerous off-label uses of high-cost 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