Regulatory and Washington

ALEXANDRIA, Va. — Simplify, simplify.


ALEXANDRIA, Va., and WASHINGTON — The war of words between independent pharmacies and the pharmacy benefit management industry again is heating up. And again, the two groups are at odds over the question of how transparent — or opaque — the PBM industry’s business dealings with its clients are, and whether those business practices demand reform.

WASHINGTON — The Consumer Healthcare Products Association recently named GlaxoSmithKline veteran Janet Carter-Smith chair of the CHPA Retailer Liaison Steering Committee, effective Jan. 1.

Carter-Smith will be the third chair of this committee, succeeding David Howenstine, VP customer and industry development at Pfizer Consumer Healthcare, whose term ends at the end of the year.

ATLANTA — The Centers for Disease Control and Prevention has set aside the week of Dec. 5 to observe this season's National Influenza Vaccination Week. The week-long emphasis on flu vaccination was established to highlight the importance of continuing influenza vaccination, as well as foster greater use of flu vaccine after the holiday season into January and beyond.

SCHAUMBURG, Ill. — The Food and Drug Administration has approved a generic chemotherapy drug made by Sagent Pharmaceuticals, Sagent said Thursday.

The FDA approved topotecan hydrochloride for injection, a version of GlaxoSmithKline’s Hycamtin. The U.S. market for injectable topotecan was around $158 million in 2010, according to IMS Health.

CAPE GIRARDEAU, Mo. (Dec. 1) Gov. Jay Nixon, D-Mo., on Tuesday campaigned for a sweeping expansion of efforts to battle methamphetamine, including legislation that would make Missouri the third state in the nation to require a prescription for the cough-cold ingredient pseudoephedrine.

It’s not a new issue for the Show Me State — several local municipalities that fall between St. Louis and the Missouri capital of Jefferson City last year passed local ordinances that required prescriptions for PSE products.

WASHINGTON — The Senate on Tuesday afforded the Food and Drug Administration new powers in regulating food, according to published reports, with the passing of the FDA Food Safety Modernization Act by a vote of 73-25 (with two abstentions).

The legislation would grant the FDA new powers to recall foods and increase inspections.

ALLEGAN, Mich. — The Food and Drug Administration has granted market exclusivity for a generic version of a medication designed to treat indoor and outdoor allergies.

Perrigo said Monday that its licensor and supplier Synthon received regulatory approval for levocetirizine tablets, a generic version of UCB/Sepracor's Xyzal, which is marketed in the United States by Sanofi-Aventis.

The levocetirizine tablet is the only approved generic product having a label containing all indications, Perrigo said.