Regulatory and Washington

SILVER SPRING, Md. — The Food and Drug Administration may require makers of antibacterial soaps to perform clinical trials to show their products are better at preventing infections and disease than ordinary soaps, part of a larger effort by the agency to ensure the safety and efficacy of antibacterial products and slow down the rise of antibiotic-resistant bacteria.

DEERFIELD, Ill. — In support of the more than 1.1 million people living with HIV in the United States, Walgreens on Monday announced its collaboration with the Centers for Disease Control and Prevention to develop and evaluate a model of HIV patient-centered care through a national project aimed at advancing clinical integration and medication therapy management. The program is another way Walgreens is extending its commitment to improve HIV prevention and treatment outcomes.

NEW YORK — Pharmacy benefit manager Express Scripts hopes to drive down the cost of new drugs to treat hepatitis C by pitting their manufacturers against each other, according to published reports.

Bloomberg News reported that ESI would pit companies like Gilead Sciences against others such as AbbVie when the new treatments become available in 2014 or 2015. The Food and Drug Administration announced last week the approval of Gilead's new drug, Sovaldi (sofosbuvir), which is designed to cut by three quarters the time needed for treatment.

ARLINGTON, Va. — The National Association of Chain Drug Stores underscored its commitment to improving the quality and affordability of the nation’s healthcare system and expressed concern about potential consequences of restricted pharmacy networks with the Patient Protection and Affordable Care Act exchange plans in a statement to the U.S. House of Representatives Oversight and Government Reform Committee. 

The committee held a hearing Friday titled, “Premiums, Provider Networks and the Health Care Law.”


ALLEGAN, Mich. — The Irish High Court has approved Perrigo's pending acquisition of Irish drug maker Elan, the companies said Friday.

NEW YORK — The National Advertising Division on Tuesday referred advertising claims made by Bremmen Clinical, for its Vysera-CLS weight-loss supplement, to the Federal Trade Commission for further review.

ALEXANDRIA, Va. — The National Community Pharmacists Association on Wednesday urged U.S. Senators on the Senate Finance Committee to support a proposal — scheduled for a vote as soon as Thursday — intended to expand coverage in the Medicare Part D prescription drug program of medication therapy management programs.

PRINCETON, N.J. — A panel of experts at the Food and Drug Administration has recommended approval for an experimental biotech drug under development by Bristol-Myers Squibb and AstraZeneca for a group of rare metabolic disorders.