Regulatory and Washington

WASHINGTON — A group representing the nation’s pharmacy benefit managers said Health and Human Services secretary Kathleen Sebelius should continue encouraging state Medicaid programs to explore affordable pharmacy solutions despite opposition from the independent drug store lobby.

CAMBRIDGE, Mass. — The Food and Drug Administration has given expedited review to a drug for preventing hemodialysis failure in patients with end-stage kidney disease.

The FDA granted fast-track review status to the cell-based therapy Vascugel, made by Pervasis Therapeutics. The FDA grants the status to accelerate review of treatments for serious and life-threatening conditions, particularly those that address serious, unmet medical conditions.

NEW YORK — The National Advertising Division of the Council of Better Business Bureaus on Tuesday referred advertising claims made by Iceberg Labs for its Immune Shield dietary supplement to the Federal Trade Commission and Food and Drug Administration for further review.

The advertising at issue was challenged before NAD, the advertising industry’s self-regulatory forum, by the Council for Responsible Nutrition.

LAKE FOREST, Ill. — The Food and Drug Administration has approved a generic cancer drug from Hospira.

The drug maker announced the approval of topotecan injection for treating small-cell lung cancer sensitive disease after first-line chemotherapy has failed.

The drug is a generic version of GlaxoSmithKline’s Hycamtin, which had sales of more than $140 million in 2010, according to Hospira.

ALEXANDRIA, Va. — Shortly after Health and Human Services secretary Kathleen Sebelius reached out to state governors about extending their Medicaid programs, the National Association of Chain Drug Stores sent a letter to Sebelius emphasizing the importance of expanding patient access to prescription drugs and pharmacy services to cut healthcare costs and improve patient outcomes.

NAPLES, Fla. — Pharmacy's role in the U.S. healthcare system has expanded dramatically over the past two years, thanks to several victories gained through pharmacy care and services.

Speaking at the National Association of Chain Drug Stores' Regional Chain Conference, NACDS board chairman and CVS Caremark president and COO Larry Merlo said that scientific research has further demonstrated how care and services provided by pharmacists and pharmacies have improved health outcomes of patients and cut costs for the healthcare system.

MUMBAI, India — The Food and Drug Administration has approved a generic Alzheimer’s disease treatment from Sun Pharmaceutical Industries.

Sun said Thursday that the FDA had approved its galantamine hydrobromide extended-release capsules in the 8-mg, 16-mg and 24-mg strengths.

The drug is a generic version of Johnson & Johnson’s Razadyne ER, which has annual sales of about $50 million, according to Sun.

WASHINGTON — The Consumer Healthcare Products Association on Friday named Vera Grill director of federal affairs, effective Feb. 8. In this capacity, Grill will coordinate and manage CHPA’s federal priorities, the association stated.

Grill comes to CHPA from the office of Rep. Charles Melancon, D-La., where she served as senior policy adviser. Prior to that, Grill worked as director of federal government relations at Pfizer.