Drugs

More States Want to Import Drugs: Bloomberg

New York is the latest state to publicly express interest in developing a program to import drugs from Canada. That’s the word in a Bloomberg Law “Deep Dive” into the issue of drug importation. “State leaders are reviving talk of importing prescription drugs from Canada, even as U.S. drugmakers and healthcare attorneys warn that logistical obstacles and looming tariffs might prevent lower prices for patients at pharmacies,” the report says.

In her January State of the State address, New York Gov. Kathy Hochul said she was exploring participation in the FDA pathway allowing states to import some drugs from Canada.

So far, FDA has only approved Florida’s program, but the state still has not opened its program. The article says that six other states have enacted laws allowing them to set up importation plans and legislation has been filed in New York, Illinois, and Mississippi.

Bloomberg Law quotes attorney Margaux Hall (Ropes & Gray) that, “I haven’t seen meaningful analysis of how this type of a program would actually lower out-of-pocket costs for a consumer at the pharmacy counter.”

The report says the possibility of a tariff against Canadian drugs could undermine any savings from imports. It also notes that FDA is excluding biologics from the list of drugs that can be imported. “If you layer on top of that potential real consumer concerns regarding the safety and efficacy of these products, there are questions regarding the extent to which the market would meaningfully respond,” Hall concluded.

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