Regulatory and Washington

NEW YORK — Pfizer is recalling a painkiller drug it acquired when it bought King Pharmaceuticals due to problems with a chemical used to deter drug abuse, according to a published report.

Reuters reported that Pfizer had recalled supplies of Embeda (morphine sulfate and naltrexone hydrochloride) because the chemical that prevents the drug from being ground up or dissolved by drug abusers — naltrexone — had deteriorated in samples of the drug that Pfizer had tested.

The drug has sales of less than $70 million per year, according to Reuters.

LITTLE ROCK, Ark. — SB 437, a bill passed Wednesday by the Arkansas House by a vote of 60-31, introduces a number of new issues to the debate on whether or not pseudoephedrine and similar ingredients should be sold behind the counter or by prescription only.

ALEXANDRIA, Va. — Commenting on a counterfeit pharmaceutical inter-agency working group report, the National Association of Chain Drug Stores stressed that it shares the goal of improving the public awareness of the risks posed from counterfeit drugs and unlawful online drug sellers, but expressed concern over the report's proposal to mandate a "track-and-trace" system in the United States, given the high cost it could pose for pharmacies.

NEW YORK — Drug makers Gilead Sciences and Roche are suing Indian drug maker Natco Pharma concerning a generic version of an influenza treatment, according to published reports.

Bloomberg reported that Gilead and Roche were accusing Natco of patent infringement due to its efforts to gain approval from the Food and Drug Administration for a generic version of Tamiflu (oseltamivir phosphate). Natco became the first company to file for approval of a generic version in February.

SILVER SPRING, Md. — The Food and Drug Administration on Wednesday announced that the only over-the-counter asthma inhaler sold in the United States no longer will be available as of Dec. 31 as part of an international agreement to stop the use of substances that damage the environment.

WASHINGTON — The National Retail Federation said legislation introduced Tuesday to delay swipe fee reform, which is scheduled to go into effect this summer, would block retailers from giving discounts to consumers who use debit cards and would cost merchants and the public more than $1 billion per month.

CAMBRIDGE, Mass. — A drug under investigation as a treatment for a rare genetic disorder that causes abnormally high triglyceride levels in the blood has received orphan-drug designation from the Food and Drug Administration.

WASHINGTON — Atico International USA issued a voluntary recall of 57,000 holiday rattle baby slippers amid a choking hazard, according to the Consumer Product Safety Commission.

The CPSC reported that the soft shoes with built-in rattles were imported from China by Atico International USA of Fort Lauderdale, Fla., and sold nationwide at Walgreens stores from October 2010 through January 2011 for about $5.