Drugs

Texas Approves Drug Import Plan

Texas has approved legislation creating a Wholesale Prescription Drug Importation Program that would contract with Canadian drug wholesalers and suppliers to bring cheaper prescription drugs into the state. The plan would require HHS approval to be implemented. The Texas Tribune reports the program will not be fully designed until next year, much less approved by HHS and implemented.

The article says the legislation was approved with overwhelming bipartisan support. State budget analysts said the program would cost $20 million a year to administer, including hiring 25 people to run it. Other costs or benefits to the state cannot be determined yet, they said.

The Tribune says the bill was opposed by the drug industry, which said that a state-based program complicates streamlined federal processes by letting state officials or importers negotiate prices, pick drugs for the program, and take part in the security and labeling process. The industry representatives also said the program would threaten the security of the nation’s drug supply chain by sidestepping the federal government’s track-and-trace distribution system.

Other opponents reportedly argued that the program would be difficult to implement because Canada is experiencing a shortage of some medicines and likely would not be able to meet U.S. demand.

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