Regulatory and Washington

SILVER SPRING, Md. — The Food and Drug Administration on Friday released draft guidance that ultimately will provide the public with previously unknown information about the chemicals in tobacco products and help prevent misleading marketing about the risks associated with tobacco products, the agency said.

NEW YORK — A diabetes treatment made by Novo Nordisk is safe for pregnant women, according to a recent decision by the Food and Drug Administration.

Novo Nordisk said Monday the FDA had approved Levemir (insulin detemir [rDNA origin]) for a pregnancy category B classification, meaning that when used by pregnant women, the insulin did not increase the risk of harm to fetuses. The agency's decision was based on results of a clinical trial involving 310 women that compared Levemir to another insulin product.

The insulin is used to treat Type 1 and Type 2 diabetes.

ALEXANDRIA, Va. — The National Association of Chain Drug Stores and the National Community Pharmacists Association on Monday afternoon announced their intent to file an additional motion requesting that the judge direct Express Scripts and Medco to keep separate their assets pending review of the lawsuit and/or schedule an expedited review of the merits of a case the two associations filed in district court last week.

WASHINGTON — The controversial merger between Express Scripts and Medco was completed Monday morning, according to a press release issued by both Express Scripts and the Federal Trade Commission.

PARSIPPANY, N.J. — GlaxoSmithKline Consumer Healthcare strongly supported efforts to inform smokers of the impact tobacco use has on the body, as well as effective ways to quit, during a congressional briefing Friday that was sponsored by Reps. Frank Pallone, D-N.J., and Tim Murphy, R-Pa.

The briefing, entitled "Understanding Smoking Addiction and How to Accelerate Quitting," addressed how to improve the nation's policies and programs to help smokers become tobacco free.

ATLANTA — Mortality rates from all cancers combined continued to drop between 2004 and 2008 among men, women and children, according to the annual "Report to the Nation on the Status of Cancer, 1975-2008."

ALEXANDRIA, Va. — The National Community Pharmacists Association on Thursday submitted written comments to the U.S. House Judiciary Committee Subcommittee on Intellectual Property, Competition and the Internet hearing on H.R. 1946, the Preserving Our Hometown Independent Pharmacies Act, in support of the bill.

ALEXANDRIA, Va. — With as much as two-thirds of retail pharmacy operators' business tied up in the potential Express Scripts-Medco merger, the National Association of Chain Drug Stores, the National Community Pharmacists Association and nine retail pharmacy companies on Thursday filed a lawsuit challenging the merger.