Drugs

Senators Press FDA for Details on Addressing Chemotherapy Shortages

Two senior U.S. senators are seeking answers from FDA about its plans to address ongoing shortages of several critical chemotherapy drugs. In an 8/5 letter to FDA acting commissioner Kyle Diamantas, Sens. Rick Scott (R-FL) and Kirsten Gillibrand (D-NY) requested a briefing by 9/4 on the agency's efforts to ease shortages of ifosfamide, carboplatin, cisplatin and oxaliplatin.

The lawmakers said shortages of the widely used generic chemotherapy drugs have forced some health systems to ration supplies, delay treatments and prioritize certain patients as inventories dwindle. According to FDA, the shortages stem from a combination of manufacturing problems, shipping delays and decisions by some manufacturers to discontinue production.

"We must do everything we can to make sure no cancer patient goes without life-saving chemotherapy drugs," Gillibrand said in a statement. "However, addressing this crisis cannot come at the expense of patient safety or a secure supply chain."

The letter follows reports that HHS has said FDA is considering temporarily allowing imports of chemotherapy drugs from overseas manufacturers that do not normally supply the U.S. market. FDA used a similar strategy during shortages of carboplatin and cisplatin in 2023. The senators said temporary imports raise questions about manufacturing quality and regulatory oversight.

Among the information requested, Gillibrand and Scott asked FDA to identify the foreign manufacturers and facilities under consideration for temporary importation, disclose the countries where they are located, and indicate whether any have received FDA Form 483 inspection observations or been classified as Official Action Indicated (OAI) or Voluntary Action Indicated (VAI), particularly for the drugs in shortage.

The senators also requested details on FDA's quality assurance protocols for imported medicines, post-market monitoring plans for contamination or reduced potency, coordination between the agency's drug shortage staff and the Office of Inspections and Investigations, the potential impact on drug costs, and long-term efforts to strengthen the chemotherapy supply chain.

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