FDA in the News This Week with Changes to Disclosure, Raids and Warnings for Unapproved Stem Cell Treatments
This week on the Bio Blog, the FDA features prominently in the headlines as Commissioner Scott Gottlieb weighs the pros and cons of shorter drug side effect disclosures and leads the charge to protect consumers against unapproved stem cell treatments. A look at this plus the acquisition of Kite Pharma by Gilead and more.
Kite Pharmaceuticals developed a unique drug called Axi-Cel which uses a patient’s own genetically modified white blood cells to attack tumors. Early results using Axi-Cel on large B-cell lymphoma look promising. Now, Gilead has purchased Kite, and the debate is on as to what Axi-Cel might actually cost the consumers. Not surprisingly, the debate is now on as to what this new medication will cost. What is the cost of a human life? A look at the debate around the high cost of pharmaceuticals from the perspective of this one medication.
It’s the butt of late-night comedy – the list of drug side effects on-camera spokespeople have to reel off before the commercial ends. We’re all familiar with this spiel, but how many people actually listen to it? FDA commissioner Scott Gottlieb wants to limit the list of side effects companies are required to state in direct to consumer drug advertising. The agency is currently asking all stakeholders, including doctors and patients, for their feedback. Studies indicate that consumers remember shorter messages better.
Women diagnosed with breast cancer are choosing a double mastectomy instead of lumpectomy or single mastectomy, according to a report in the Annals of Surgery. In an age when surgeries are less invasive thanks to technology, why this change? This report looks at the complex interplay of financial, emotional, and practical considerations driving women to choose the more drastic option when confronting a breast cancer diagnosis.
Gilead Sciences Inc. is buying Santa Monica-based Kite Pharma Inc. for $11.9 billion. Gilead expects to maintain and even expand the Los Angeles-area complex where Kite is based, including a 100,000 square foot manufacturing facility in El Segundo. Gilead’s acquisition of Kite means it is expanding its portfolio of cancer-fighting drugs. Kite is on the verge of approval for a new treatment for non-Hodgkin’s lymphoma that uses a patient’s own immune cells to fight tumors.
The Centers for Medicare & Medicaid Services (CMS) released CY 2018, proposed Hospital Outpatient Prospect Payment System (OPPS) on July 13, 2017. The agency proposed changes to the 340B Drug Pricing Program.
Richard P. Mansour, MD, and Samip Master, MD, successfully used data from an electronic health record (EHR) and Microsoft SQL Server database management system to complete the Quality Oncology Practice Initiative (QOPI®) measure NHL 78a, which addresses Hepatitis B testing in patients with non-Hodgkin lymphoma. ASCO’s Quality Oncology Practice Initiative (QOPI®) is a voluntary and free ASCO member benefit program intended to assists practices with improving quality of care.
The FDA raided a San Diego-based stem cell treatment center, seizing vials of a live virus that was being mixed with stem cells and injected into cancer patients’ tumors. They also issued a warning letter to Florida-based U.S. Stem Cell Inc. for selling unapproved stem-cell treatments. These treatments were injected into patients’ spinal cords. The FDA appears to be cracking down on unapproved stem cell treatments.
Statement from FDA Commissioner Scott Gottlieb, M.D. on the FDA’s new policy steps and enforcement efforts to ensure proper oversight of stem cell therapies and regenerative medicine
A statement from FDA Commissioner Scott Gottlieb on the agency’s efforts to crack down on unapproved or unauthorized use of stem cell treatments. The agency is taking steps to protect patient safety in the area of stem cell treatments.
In last week’s BioBlog, 8/27/2017, the post title incorrectly referred to the 340B drug pricing program as ‘350B’. The post title has been corrected.