Drugs

AMA Backs Some Canadian Drug Imports

The American Medical Association (AMA) 2018 interim meeting has adopted a report saying that letting Americans import prescription drugs in person from licensed Canadian brick-and-mortar pharmacies could improve cost-sharing levels and address a major barrier to medication adherence. An AMA statement says Canadians spend about half the $1,026 that Americans spend, per capita, on prescription drugs each year.

“Allowing for the in-person importation from licensed Canadian pharmacies is not a comprehensive long-term solution to addressing the problem of unaffordability of prescription drugs in the U.S.,” says an AMA Council on Medical Service report. “However, patients that face high and unaffordable costs for their prescription drugs need relief in the meantime.”

The association House of Delegates adopted policy to:

support in-person purchase and importation of Health Canada-approved prescription drugs from a licensed Canadian pharmacy “when product integrity can be assured, provided such drugs are for personal use and of a limited quantity”; and
advocate for increased funding for FDA to administer and enforce a program that allows in-person purchase and importation of prescription drugs from Canada if the integrity of products imported for personal use can be assured.

AMA policy opposes the personal importation of prescription drugs over the Internet until patient safety can be assured. It also opposes illegal importation of prescription drugs and drug counterfeiting.

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