Drugs

4 Former FDA Heads Criticize Drug Importation

Four former FDA commissioners have penned an open letter to Congress urging the lawmakers to not allow the importation of drugs not approved by the agency as a means to make lower-cost therapies available to U.S. citizens. Signed by Robert M. Califf, Margaret B. Hamburg, Mark B. McClellan, and Andrew von Eschenbach, the letter warns that such importation would be a “complex and risky approach—one that the evidence shows will not achieve the aim, and that is likely to harm patients and consumers and compromise the carefully constructed system that guards the safety of our nation’s medical products.”

The former commissioners support the “closed” distribution system here in the U.S., saying that it “provides assurance that good manufacturing practices are used and that the increasingly complex supply chain, including shipment and storage, is carefully monitored to ensure the quality a concerns about access to and costs of prescription drugs, particularly innovative therapies with major benefits for people with serious diseases.” Allowing drug importation “would be very different from importation of consumer products like watches or clothing, where consumers can more easily discern quality and where there are no health consequences of fake products,” they say. “It could lead to a host of unintended consequences and undesirable effects, including serious harm stemming from the use of adulterated, substandard, or counterfeit drugs. It could also undermine American confidence in what has proven to be a highly successful system for assuring drug safety.”

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