Drugs

3 Ways Congress Can Cut Drug Shortages: Duke-Margolis

The Duke-Margolis Institute for Health Policy says there are three steps Congress could take to reduce chronic drug shortages. In a 2/5 letter to the House Ways and Means Committee, the institute says many drug shortages are caused by manufacturing quality issues. “Ultimately,” it says, “this poor performance in manufacturing reflects problems in healthcare purchasing and payment. Payers and providers lack insights into manufacturers’ supply chains and quality management practices and generally have not invested enough on their own into gaining further insights. Drug purchasers choose suppliers based primarily on price, not reliability.”

The letter says that many of the most important and effective policy solutions that can help to address the economic root causes of drug shortages are within the purview of this House committee and the Senate Finance Committee. It recommends consideration of these potential policy solutions:

enable demand-side reforms for reliability, including a “reliable drug supply payment adjustment” that would adjust Medicare payments to hospitals based on whether they engage in reliable drug purchasing practices when buying certain essential generic medicines;
improve quality management and supply chain practices; and
advance federal coordination.

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