Drugs

Durbin Urges FDA to Act More on Cancer Drug Shortage

Senator Dick Durbin (D-IL) is urging FDA to take immediate action to improve supply shortages of critical cancer drugs. In a 6/1 letter to FDA commissioner Robert Califf, Durbin cited shortages with two chemotherapy drugs — carboplatin and cisplatin — that are used in treating hundreds of thousands of cancer patients each year in the U.S. “Both of these drugs are facing a nationwide shortage due to a fragile supply chain, limited market competition, and following an inspection and the identification of quality issues at a single manufacturing facility in India,” Durbin wrote.

“The agency should use its authority to allow for the safe importation of these drugs from other countries, work with manufacturers to extend expiration dates — if safe and appropriate — on existing supplies of the drugs, regularly provide clear and timely updates to providers on expected timelines for additional supply, and ensure expedited inspections and reviews to assist in resolving this shortage.”

Additionally, Durbin’s letter raised the iissue of the drug shortages' negative affects on important medical research and ongoing clinical trials. “For example, last month, a major breakthrough out of Northwestern Medicine was achieved after researchers were able to open the blood-brain barrier to more effectively deliver chemotherapy to brain tumors,” he wrote. “This breakthrough holds great promise for the treatment of glioblastoma and other neurological diseases and conditions. However, one of the chemotherapy drugs used in this research was carboplatin, which is now facing a shortage. Imagine if the researchers involved in this effort had not been able to access carboplatin during the course of their work. The best-case scenario is that the breakthrough would have been delayed by months or years. The worst-case scenario is that the breakthrough never would have been achieved at all.”

UPDATED LATE 6/2:
FDA has granted Qilu Pharmaceutical Co., in coordination with Apotex, permission to temporarily import cisplatin injection 50 mg/50 mL (1 mg/mL) vials into the U.S. market to address the current drug shortage. The product is available via Apotex’s authorized distributors (see Dear Health Care Provider Letter).

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