Regulatory and Washington

NEW YORK — While regulations for biosimilars work their way through the Food and Drug Administration, state governments are already looking at legislation concerning the substitution of biosimilars for their branded counterparts, according to a legal affairs blog focused on the FDA.

In a post Friday on FDA Law Blog, the official blog of the law firm Hyman, Phelps & McNamara, attorney Kurt Karst wrote that several states were laying the groundwork for such legislation, recalling state-level antisubstitution laws targeting generics that were adopted in the 1970s.

SCOTTSDALE, Ariz. — The Food Marketing Institute gave an outgoing executive one of its top awards at a supermarket industry conference, the group said Monday.

FMI gave VP government relations Anne McGhee Curry its Glen P. Woodard, Jr. Award for her work in public affairs over the last three decades. Curry will retire from FMI at the end of this month.

NEW YORK — The Food and Drug Administration is allowing Roche to tap its reserves of the flu drug Tamiflu, according to published reports.

Reuters reported that the Swiss drug maker would start selling its reserve stock of the adult formulation of the drug, whose chemical name is oseltamivir.

The FDA has reported spot shortages of the pediatric formulation of the drug, but has said pharmacists can break open the capsules and dissolve it in liquid to create a substitute. Meanwhile, a shortage of the adult formulation has appeared in Canada.

ATLANTA — The Centers for Disease Control and Prevention on Friday reported a slight drop in influenza-like illnesses across the country, but even so the season is still going strong. The proportion of outpatient visits for influenza-like illness for the week ended Jan. 12 was 4.6%, above the national baseline of 2.2%

WASHINGTON — The dietary supplement industry’s self-regulatory coalition, the SIDI Work Group, on Thursday announced the release of its voluntary Dietary Supplement Component Supplier Qualification Guideline — a document designed to assist the industry in supply chain integrity, which is a requirement for complying with current good manufacturing practices. 

SILVER SPRING, Md. — The Food and Drug Administraiton has approved a treatment for replacing clotting proteins in the blood for conditions in which patients have too little of them.

The FDA announced the approval of Octapharma's Octaplas, a sterile, frozen solution of pooled human plasma from multiple donors that has been treated with a solvent detergent process.

WASHINGTON — More than 5,000 medicines are under development, of which 70% are potentially the first of their class, according to a new report.

SILVER SPRING, Md. — The Food and Drug Administration on Wednesday approved Protein Sciences' Flublok, the first trivalent influenza vaccine made using an insect virus (baculovirus) expression system and recombinant DNA technology.