Drugs

Vermont Allows Canadian Drug Imports

Vermont has become the first state to approve legislation permitting a U.S. drug wholesaler to import drugs from a Canadian wholesaler. The law still has to be certified by HHS. The Trump administration has opposed such drug importation. The Hill reports that HHS secretary Alex Azar called the idea of importing drugs from another country “a gimmick.”

The idea also has been criticized by drug companies. Pharmaceutical Research and Manufacturers of America issued a statement saying that “lawmakers cannot guarantee the authenticity and safety of prescription medicines when they bypass the FDA approval process, and the Canadian government does not inspect or take responsibility for the legitimacy of prescription medicines shipped to the U.S. The burden of combating illicit drugs would fall on local law enforcement officials, who lack the capacity to inspect even a small percentage of increased counterfeit drugs, but who have witnessed their impact in communities across the state.”

The Hill reports that the Vermont law is built on model legislation from the National Academy for State Health Policy. Eight states reportedly have proposed similar legislation this year, and Vermont’s is the first to be signed into law.

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