Drugs

Reviews May Ease Drug Shortages: GAO

The Government Accountability Office (GAO) says that to help address drug shortages, FDA prioritized review of 383 drug applications and supplements between calendar years 2010 and 2015. Most were for generic sterile injectable drugs. “FDA’s approval of some of these submissions occurred before the shortage was resolved,” a new GAO report on drug shortages says. “Although the timing of FDA’s approval does not establish a causal link, it could indicate that FDA’s action helped address some shortages.”

The review found that while the number of new drug shortages has generally dropped since 2010, the number of ongoing shortages remained high. As part of FDA’s oversight of drug safety and quality, it generally issued an increasing number of GMP Warning Letters to sterile injectable drug establishments during the time period GAO reviewed. The percentage of inspections resulting in Warning Letters remained small, according to the report, even as the number of inspections increased.

Shortages of sterile injectable anti-infective and cardiovascular drugs in 2012-2014 were strongly associated with certain factors GAO examined, the watchdog agency says. Two factors — a decline in the number of suppliers and failure of at least one establishment making a drug to comply with manufacturing standards resulting in a Warning Letter — suggest that shortages may be triggered by supply disruptions, according to the report. A third factor, drugs with sales of a generic version, suggests that due to relatively low profit margins for generic drugs, manufacturers are less likely to increase production, making the market vulnerable to shortages.

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