Regulatory and Washington

ATLANTA — This year's triumvirate influenza vaccine was less effective in seniors as compared to the general population, according to the Centers for Disease Control and Prevention's "Morbidity and Mortality Weekly Report" published Friday. Overall effectiveness of the vaccine was 56%, similar to an earlier interim estimate of 62%. 

The adjusted, age-stratified vaccine effectiveness point estimates were 58% for children, 46% for adults younger than 50, 50% for men and women between the ages of 50 years and 64 years and 9% for seniors. 

WASHINGTON — Patients around the country "strongly" oppose laws that have been proposed to change popular OTC drugs to prescription-only, according to a new survey.

The survey, conducted online by Harris Interactive on behalf of the Asthma and Allergy Foundation of America, polled 2,020 adults in January who had asthma, allergies, cold, cough or flu in the past 12 months and who had purchased OTC drugs for at least one condition during that time.

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.

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.

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."

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.