Drugs

Progress Seen in 3 Drug Shortages

CDER deputy director for regulatory programs Douglas Throckmorton says IV fluid shortages that have existed since 2014 and were exacerbated by Hurricane Maria’s effect on Puerto Rican drug manufacturers in 2017 are finally easing. An agency news release says that “after much work and a great deal of collaboration with a wide range of stakeholders, these IV fluid shortages are beginning to improve.” He notes that Baxter Healthcare, which was particularly hard hit by the hurricane, is now producing at significantly higher levels, and several other companies are producing critically-needed saline.

The release also addresses the shortage of injectable opioid analgesics and EpiPens. A 2017 manufacturing-related shortage of injectable opioid analgesics was addressed in part by enlisting the support of other companies that make the products to help close the demand gap, Throckmorton says. He says that much of the shortage was caused by production delays due to changes and upgrades at a Pfizer facility in Kansas and recent issues related to manufacturing quality at the same facility.

“While Pfizer expects that delays will continue until 2019,” Throckmorton writes, “we are working with them to increase supplies before then.” He says FDA also is working with other companies that manufacture FDA-approved injectable analgesics to increase their production.

An EpiPen shortage was caused by multiple factors, including regional supply disruptions and manufacturer issues, Throckmorton says. Based on information from Mylan, he writes, FDA expects the issue to be short-term. FDA also reminds healthcare providers, pharmacists, and patients, that there are alternative epinephrine products that can be used safely and effectively.

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

Read more

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