Key Treatment Shortages Impacting Care Of Those With Cancer

CIDRAP: Shortages Of 4 Drugs May Complicate Cancer Care
Amid shortages of three generic drugs widely used to treat common cancers in both adults and children, hospital officials worry that they may have to treat patients with less-effective medications or lower-than-recommended doses, Endpoints News reports. Injectable methotrexate, cisplatin, and fluorouracil are all in shortage, according to the American Society of Health-System Pharmacists (ASHP). Methotrexate comes in both oral and injectable forms, while the other two drugs are available only as injectables. (Van Beusekom, 3/16)

CBS News: Drug Used To Treat Advanced Prostate Cancer In Short Supply, Novartis Says
Pluvicto, a drug used to treat advanced prostate cancer, is in short supply, the Food and Drug Administration reported last week. Novartis, the pharmaceutical company that manufactures Pluvicto, outlined the causes behind the supply issues in a letter posted by the FDA last month. (Howard, 3/16)

In FDA and other administration news —

Stat: Califf Criticizes Insurers For Doing Too Little On Drug Research
FDA Commissioner Robert Califf wants private insurers to chip in on doing post-approval clinical research on drugs. It’s a new request from the agency chief, who’s long pushed to find new ways to test drugs. “I’m not aware of a major effort by the insurance plans to help people get studies done,” he said at America’s Health Insurance Plans conference on Thursday. “In fact, what I’m hearing from clinicians out there is just the opposite, that it’s very hard to do research in the current environment.” (Wilkerson, 3/16)

Stat: FDA To Ask For Expert Review Of Sarepta Gene Therapy For Duchenne
In a sudden about-face, the Food and Drug Administration will hold a meeting of outside experts to consider whether or not to approve Sarepta’s experimental gene therapy for Duchenne muscular dystrophy. The announcement Thursday comes just weeks after the company said the FDA had told it an advisory panel meeting to review the treatment, called SRP-9001, would not be necessary. The decision to review Sarepta’s gene therapy without input from outside experts surprised some analysts and patient advocates. (Mast and Feuerstein, 3/16)

Reuters: Alzheimer's Association Lobbies For Medicare Coverage Of Leqembi And Other Drugs
The Alzheimer's Association has deployed 1,000 people diagnosed with, or caring for someone with the disease, to meet with all 535 members of Congress across the United States and urge them to press Medicare for early access to a new class of drugs, beginning with lecanemab, that promise to slow the disease. The grassroots lobbying campaign, which has not been reported in detail, is being led by state-based chapters, according to interviews with four Association national and local officials. (Aboulenein, 3/16)

Also in pharmaceutical news —

Reuters: Pfizer To Replace Migraine Drug Packaging Over Child Safety Concerns 
Pfizer Inc said on Thursday it was working on a new child-proof packaging for its migraine drug, Nurtec ODT, after safety concerns led to a recall alert from the U.S. Consumer Product Safety Commission. Consumers should immediately secure the recalled product out of the sight and reach of children and contact Pfizer for a free child-resistant pouch to store it, the CPSC said. (3/16)

The New York Times: What To Know About The Recent Eye Drop Recalls 
Global Pharma, which makes EzriCare and Delsam Pharma’s eye drops, recalled both products in February. Last week, a Florida woman sued Global Pharma, claiming that an infection caused by the eye drops was so severe that doctors had to surgically remove one of her eyes. (Holpuch, 3/16)

Stat: Here's Why There Aren't Many Cheap, Generic Versions Of Inhalers
U.S. regulators approved dozens of inhalers to treat asthma and chronic obstructive pulmonary disease over a recent 15-year period, but a new study found that generic companies have only twice successfully pursued an established pathway to create lower-cost, rival products. (Silverman, 3/16)

Stat: Polio Cases Derived From New Oral Vaccine Reported For First Time
Experts have long understood that a new polio vaccine developed to try to minimize the risks associated with the oral polio vaccine made by Albert Sabin might also cause the problem it was created to sidestep. It’s now clear that theoretical risk is a real one. The Global Polio Eradication Initiative announced Thursday that six children in the Democratic Republic of the Congo and one in Burundi have been paralyzed by viruses from the new vaccine, which is referred to as novel oral polio vaccine, or nOPV2. (Branswell, 3/16)