FDA Approves Padcev (enfortumab vedotin-ejfv) for Advanced Urothelial Cancer

Trump Administration Issues Proposed Rule on Importation of Prescription Drugs

The proposed rule applies to drugs that meet FDA labeling standards and impose no risk to health and safety. The import rule excludes controlled substances, biological products and intravenous drugs. (FDA's Safe Importation Action Plan.)

Comments on the NPRM are being accepted for 75 days after publication in the Federal Register and comments on the draft guidance are being accepted for 60 days after publication in the Federal Register.

Read the HHS press release.
Read Importation of Prescription Drugs Proposed Rule.
Read new draft guidance for industry.

FDA Approves Enzalutamide for Metastatic Castration-Sensitive Prostate Cancer

On Dec. 16, 2019, the U.S. Food and Drug Administration (FDA) approved enzalutamide (Xtandi, Astellas Pharma Inc.) for patients with metastatic castration-sensitive prostate cancer (mCSPC).

FDA previously approved enzalutamide for patients with castration-resistant prostate cancer.

Read the FDA announcement.

Posted 12/17/2019

Senate Confirms Dr. Stephen Hahn as U.S. FDA Commissioner

On Dec. 12, 2019, the U.S. Senate voted to confirm radiation oncology Stephen Hahn, MD, FASTRO, as the next Commissioner of the U.S. Food and Drug Administration (FDA).

Posted 12/12/2019  

FDA Approves Atezolizumab + Chemotherapy for Metastatic Non-Squamous NSCLC

FDA Approves Reblozyl for Anemia in Adults with Beta Thalassemia

REBLOZYL is not indicated for use as a substitute for RBC transfusions in patients who require immediate correction of anemia.

Beta thalassemia, also called “Cooley’s anemia,” is an inherited blood disorder that reduces the production of hemoglobin, an iron-containing protein in red blood cells that carries oxygen to cells throughout the body. In people with beta thalassemia, low levels of hemoglobin lead to a lack of oxygen in many parts of the body and anemia, which can cause pale skin, weakness, fatigue and more serious complications. Supportive treatment for people with beta thalassemia often consists of lifelong regimens of chronic blood transfusions for survival and treatment for iron overload due to the transfusions. People with beta thalassemia are also at an increased risk of developing abnormal blood clots.

Read the FDA announcement.

Posted 11/25/2019

FDA Approves New Treatment Option for CLL Under International Collaboration

CMS Issues Rules on Price Transparency for Hospitals and Health Insurance Issuers

On Nov. 15, the Centers for Medicare & Medicaid Services (CMS) issued two rules that aim to increase price transparency and increase competition among all hospitals, group health plans, and health insurance issuers in the individual and group markets. The agency finalized the calendar year (CY) 2020 Outpatient Prospective Payment System (OPPS) & Ambulatory Surgical Center (ASC) Price Transparency Requirements for Hospitals to Make Standard Charges Public rule, and issued the Transparency in Coverage Proposed Rule. Both rules (final and proposed) require that pricing information be made publicly available.

The final "Price Transparency Requirements for Hospitals to Make Standard Charges Public" rule will require hospitals to make their standard charges public in two ways starting in January 1, 2021:

• Comprehensive Machine-Readable File: Hospitals will be required to make public all hospital standard charges (including the gross charges, payer-specific negotiated charges, the amount the hospital is willing to accept in cash from a patient, and the minimum and maximum negotiated charges) for all items and services on the Internet in a single data file that can be read by other computer systems. The file must include additional information such as common billing or accounting codes used by the hospital (such as Healthcare Common Procedure Coding System (HCPCS) codes) and a description of the item or service to provide common elements for consumers to compare standard charges from hospital to hospital.
• Display of Shoppable Services in a Consumer-Friendly Manner: Hospitals will be required to make public payer-specific negotiated charges, the amount the hospital is willing to accept in cash from a patient for an item or service, and the minimum and maximum negotiated charges for 300 common "shoppable services" in a consumer-friendly way and update the information at least annually.

CMS fact sheet on final rule.
Access final rule.

CMS states that the proposed "Transparency in Coverage" rule is issued in response to an Executive Order dated June 24, 2019. The Department of Health and Human Services, the Department of Labor, and the Department of the Treasury are collectively issuing the proposed rule. As written, the rule would require that most employer-based group health plan and health insurance issuers provide up-front disclosure of price and cost-sharing information to participants, beneficiaries, and enrollees. 

If finalized, the "Transparency in Coverage" proposed rule would require health plans to:

• Provide consumers with real-time, personalized access to cost-sharing information, including an estimate of their cost-sharing liability for all covered healthcare items and services, through an online tool that most group health plans and health insurance issuers would be required to make available to all of their members, and in paper form, at the consumer’s request. This would allow consumers to shop and compare costs between specific providers before receiving care.

Disclose on a public website their negotiated rates for in-network providers and allowed amounts paid for out-of-network providers. Making this information available to the public is intended to drive innovation, support informed, price-conscious decision-making, and promote competition in the healthcare industry.  

Access a CMS fact sheet on the proposed rule.
Access the proposed rule.

More details are available in the HHS press release.

FDA Grants Accelerated Approval to Zanubrutinib for Mantle Cell Lymphoma

FDA Office of Hematology Oncology Products, Now Called Office of Oncologic Diseases

On November 5, the U.S. Food and Drug Administration (FDA) announced that the FDA's office responsible for reviewing applications for new and existing cancer therapies has reorganized and been renamed as part of modernization plans approved in September 2019.

The Center for Drug Evaluation and Research (CDER) Office of Hematology and Oncology Products (OHOP) has been reorganized and renamed the Office of Oncologic Diseases (OOD).

Richard Pazdur, M.D., who joined the FDA in 1999 as director for the Division of Drug Oncology Products and became the OHOP Director in 2005, is the acting director of OOD.

Read FDA press release.

Posted 11/06/2019