What We're Reading: FDA Orders e-Liquids Off the Shelves; Medicare Law on Scans Stalled; Vascepa Delays

August 9, 2019
AJMC Staff
AJMC Staff

The FDA ordered 4 companies to stop selling 44 of their flavored e-liquid and hookah tobacco products that lack the required approval for sale; CMS has yet to implement a 2014 law preventing unnecessary, expensive screening tests (magnetic resonance imaging, computed tomagraphy scans and other tests) that could harm patients and waste resources; Amarin, which is seeking FDA approval for an expansion of Vascepa labeling to include data that showed a 25% reduction in the risk of heart attacks and strokes, said the FDA has scheduled an advisory committee meeting for November 14.

FDA Orders 44 Flavored e-Liquid, Hookah Tobacco Products Off the Market

The FDA ordered 4 companies to stop selling 44 of their flavored e-liquid and hookah tobacco products that lack the required approval for sale, the agency said. The FDA said the products were launched after the effective date of a rule that extended FDA's authority to all tobacco products. Reuters reported the move comes against the backdrop of the FDA's efforts to curb the usage of the addictive substances among young adults.

2014 Law Aimed at Curbing Inappropriate Medical Imaging Yet to Take Effect

Amarin Says FDA to Convene Advisory Committee Meeting on Vascepa in November

CMS has yet to implement a 2014 law preventing unnecessary, expensive screening tests (magnetic resonance imaging, computed tomagraphy scans and other tests) that could harm patients and waste resources, NPR reported. The law requires that doctors consult clinical guidelines before Medicare will pay for many common medical scans. Although the law is slated to begin in January 2020, it will be a "testing" period, which means that Medicare will still pay for the scan even if guidelines are not consulted.

Amarin, which is seeking FDA approval for an expansion of Vascepa labeling to include data that showed a 25% reduction in the risk of heart attacks and strokes, said the FDA has scheduled an advisory committee meeting for November 14, Stat News reported. Last week, the company said it was “unlikely” that the agency would want a formal meeting for its fish oil-derived drug. The agency’s deadline for making an approval decision will also likely be extended into late December from September 28, the company said.