Drugs

Canadian Drug Imports Won’t Help U.S.: Study

A Canadian Health Policy Institute (CHPI) study says the U.S. won’t be able to manage healthcare costs by importing prescription drugs from Canada. CHPI CEO Brett Skinner looked at 2023 Canadian and American sales volumes for the 27 prescription drugs listed for importation in proposals submitted by Colorado and Florida to FDA for approval, CHPI says. He reportedly found that U.S. demand would deplete the entire Canadian stock of the drugs within 57 days on average.

“American consumers outnumber Canadian consumers by a ratio of more than 8 to 1,” he says. “Manufacturers will not over-supply the Canadian market, and the Canadian government will ban exports to prevent shortages.” He also reported that state importation programs would not generate the consumer savings required for FDA approval because Canadian distributors will mark up the price of exported drugs to capture the difference.

“Manufacturer list prices for patented medicines are capped by Canada’s federal government, but the regulations apply only to sales to Canadian customers,” Skinner explained. “Caps on wholesale and pharmacy mark-ups apply only to sales reimbursed by public drug plans. There are no regulations on the prices of exported drugs.”

Skinner says the importation plan has the tacit endorsement of both major party presidential candidates.

The study is available here.

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