Regulatory and Washington

NEW YORK — One of the Food and Drug Administration's chief duties is ensuring the quality of food and drug products, and that was the focus of a keynote address delivered Friday morning by FDA commissioner Margaret Hamburg at the Generic Pharmaceutical Association's annual meeting.

In the address, viewed via webcast, Hamburg addressed issues ranging from quality to drug shortages to follow-on biologics, praising the generics industry's role in contributing more than $1 trillion in savings to the healthcare system over the past decade.

ARLINGTON, Va. — The head of a trade organization for retail pharmacies critiqued the conclusions of an op-ed published in the Wall Street Journal that cast doubt on some of the potential benefits of accountable care organizations.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new treatment for late-stage breast cancer, the agency said Friday.

The FDA announced the approval of Genentech's Kadcyla (ado-trastuzumab emtansine) for HER2-positive breast cancer that has spread to other parts of the body. HER2 is a protein involved in the growth of normal cells but found in increased amounts in some kinds of cancer cells, which contributes to cancer cell growth and survival. Genentech is the U.S. subsidiary of Swiss drug maker Roche.

NEW YORK — Overall Medicare prescription drug costs will go down in 2014, but the so-called "doughnut hole" coverage gap will get bigger, according to published reports.

Reuters reported that per-capita drug costs for Medicare Part D will drop from this year's $325 to $310 next year, and insurance premiums might go down as well.

KING OF PRUSSIA, Pa. — The Food and Drug Administration has approved a new vial size for a drug made by CSL Behring to treat a bleeding disorder and an immune disorder, the company said Thursday.

ORLANDO, Fla. — The Generic Pharmaceutical Association re-elected its chairman from last year and appointed a new board of directors for 2013 whose members run from A to Z — as in Amneal to Zydus.

"We are grateful for the vision and support of the 2012 board of directors, and we are excited to move ahead with our chairman and our 2013 board," GPhA president and CEO Ralph Neas said. "In a time of enormous change and growth for our industry, leadership is critical."

WOODCLIFF LAKE, N.J. — Valeant Pharmaceuticals has bought rights to a drug used to treat skin cancer from Eisai, the companies said Thursday.

Valeant has bought the rights to Targretin (bexarotene) capsules and gel from Eisai for $65 million upfront, plus additional payments based on certain milestones. Under the deal, Eisai has transferred its regulatory approval application to Valeant, which will assume responsibilities for all regulatory obligations associated with the product in the United States. Eisai will retain rights to the drug outside the United States.

OKLAHOMA CITY — Legislation that would require pharmacy benefit managers to seek licensure from the Oklahoma State Board of Pharmacy if they were to distribute medicines to Oklahoma residents was introduced on Tuesday, according to an Associated Press report.