Drugs

Most Drug Shortages are Manufacturing Related: FDA

The main causes of drug shortages continue to be manufacturing quality issues and manufacturing production delays, according to CDER Drug Shortage Staff team leader Emily Thakur. In an online post, Thakur talks about recent drug supply challenges, shares new FDA guidance, and offers solutions to resolve drug shortages.

“It is the drug manufacturers’ responsibility to provide FDA with certain information related to potential supply disruptions, and we work closely with manufacturers to prevent or reduce the impact of shortages that may result,” Thakur says. “The Coronavirus Aid, Relief, and Economic Security Act, or CARES Act, included authorities intended to enhance FDA’s ability to identify, prevent, and mitigate possible shortages of drugs by, among other things, enhancing our visibility into the drug and medical product supply chains.”

Specific authorities to assist FDA do this include notifying the agency about permanent discontinuances and interruptions in active pharmaceutical ingredient manufacturing; creating risk management plans in manufacturing facilities; and reporting the amount of listed drugs and biological products manufactured. An increase in demand can also lead to shortages, but unfortunately companies are not required to notify the agency about demand fluctuations, which makes the matter all the more difficult to preemptively address, Thakur says.

Additionally, Thakur notes that when the agency confirms a potential drug shortage, it posts relevant information on the Drug Shortages Web site. “We update the drug shortage list daily with new and resolved shortages, as well as additional information we receive from suppliers on their manufacturing capacity,” she says.

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