Drugs

Bill Would Speed Generic Drug Access, Lower Costs

Reps. David McKinley (R-WV) and Peter Welch (D-VT) have introduced the Fair Access for Safe and Timely (FAST) Generics Act to “thwart manipulation of FDA’s drug safety regulations in order to block the production of generic alternatives to brand name medicines.” The two say the bill would increase consumer access to generic drugs, boost market competition, and save consumers money.” It aims to eliminate instances when branded drug companies block generic drug developer access to samples of the reference-listed products they need.

“The high cost of brand name drugs should never force patients to make painful financial decisions,” McKinley said it a statement. “Our bipartisan bill will allow more people to access generic alternatives by providing competition in the marketplace and removing unnecessary bureaucratic delays from the federal government.”

The statement says there currently are companies that “abuse FDA drug safety programs by withholding access to drug samples for generic manufacturers, resulting in anticompetitive practices and increased pharmaceutical costs.”

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