Regulatory and Washington

ALEXANDRIA, Va. — The National Association of Chain Drug Stores has announced that it will hold its fourth annual NACDS RxImpact Day on Capitol Hill on March 21 to 22 in Washington, D.C.

The event will bring pharmacists, pharmacy leaders, students and other pharmacy advocates to meet with lawmakers to discuss the value of community pharmacy in improving health and reducing healthcare costs across the board.

SILVER SPRING, Md. — Fake versions of a cancer drug made by Roche's U.S. unit have entered the United States, the Food and Drug Administration warned Wednesday.

The FDA advised healthcare professionals and patients that a counterfeit version of Genentech's Avastin (bevacizumab) had been distributed in the United States. The agency said the counterfeit versions carried Roche's logo instead of Genentech's and displayed batch numbers starting with B6010, B6011 or B86017.

FOSTER CITY, Calif. — The Food and Drug Administration is giving priority review to a drug made by Gilead Sciences that the company is investigating for the prevention of HIV.

Gilead said the FDA gave the special designation to its application for Truvada (emtricitabine and tenofovir disoproxil fumarate) for pre-exposure prophylaxis, or PrEP, to reduce the risk of HIV infection. The FDA originally approved Truvada for treating HIV infection in 2004, and it is currently the most prescribed antiretroviral drug in the United States.

NEW YORK — The National Advertising Division of the Council of Better Business Bureaus on Monday recommended that Barlow Herbal Specialties discontinue advertising its LDM-100 dietary supplement as a "plant or herb antibiotic."

In its advertising statement, Barlow agreed to discontinue the challenged claims. However, a video embedded on the company's website as of Feb. 14 touted LDM-100 as an "antiviral" and "antifungal" good for use during cold and flu season.

NEW YORK — The National Advertising Division of the Council of Better Business Bureaus on Monday reported Direct Digital, marketer of Instaflex, has supported certain advertising claims made in print and online.

Instaflex is formulated with 1,500 mg glucosamine sulfate, 500 mg methylsulfonylmethane, 250 mg ginger root extract and 4 mg hyaluronic acid. Direct Digital had claimed that Instaflex could relieve and comfort joints and increase flexibility, among other claims.

PITTSBURGH — Generic drug maker Mylan plans to challenge a court decision that requires it to pay almost $20 million to a drug company whose product it tried to market as a generic.

Sunovion Pharmaceuticals sued Mylan and several subsidiaries in the U.S. District Court for the District of Delaware when the latter sought to market a generic version of Sunovion's Xopenex (levalbuterol hydrochloride) inhalation solution, a drug for asthma and chronic obstructive pulmonary disease. The jury's verdict includes an $18 million award.

WASHINGTON — The National Consumers League, the National Association of Chain Drug Stores Foundation and the American Association of Colleges of Pharmacy have recognized five pharmacy schools for their public education efforts to help patients adhere to their medication routines.

Multibillion-dollar pharmacy benefit management companies are advertising aggressively to try to convince Congress and the Federal Trade Commission to approve a merger between Express Scripts and Medco Health Solutions (“PCMA launches advertising campaign,” Drug Store News, Jan. 17).