Regulatory and Washington

NEW YORK — Bills introduced in the legislatures of nearly a dozen states have pharmacy benefit managers and the generic drug industry fearing that the bills could lead to limits on doctors’ abilities to prescribe generics through e-prescribing.

The Pharmaceutical Care Management Association, the main lobby for PBMs, said the bills would prohibit doctors from seeing lower-cost drug options, including generics and preferred brands; would prevent the e-prescribing software from showing safety information; and would disallow lower-cost pharmacy options.

ST. LOUIS — The Food and Drug Administration has approved a painkiller delivered through a skin patch made by Mallinckrodt, the generic drug maker said Friday.

Mallinckrodt, part of Covidien, said the FDA approved its fentanyl transdermal system patch.

The patch is a generic version of Johnson & Johnson’s Duragesic. The drug, an opioid and Class II controlled substance, is used for managing persistent, moderate-to-severe pain that requires continuous opioid administration.

ALEXANDRIA, Va. — The National Community Pharmacists Association has expressed support of legislation that seeks to overturn two provisions in the Obama healthcare law that limit a patient’s choice in how to use consumer-directed health savings plans.

WASHINGTON — Recent restrictions imposed on flexible spending accounts appear to be the first piece of ObamaCare to be challenged by the new Congress.

Sen. Kay Bailey Hutchison, R-Texas, and Rep. Erik Paulsen, R-Minn., on Thursday respectively introduced The Patients’ Freedom to Choose Act, a bill that would repeal two provisions in the Obama healthcare law that limit a patient’s choice in how to use consumer-directed health savings plans, to the Senate and House of Representatives.

SILVER SPRING, Md. — The Food and Drug Administration will propose an amendment to the over-the-counter laxative monograph that sodium phosphate salts are not generally recognized as safe for bowel cleansing.

A request for public comments will be published in Friday’s Federal Register.

MORRISTOWN, N.J. — Actavis has received approval from the Food and Drug Administration to market a generic version of a popular gastroesophageal reflux disease treatment.

The generic drug maker said it would market pantoprazole sodium delayed-release tablets in the 20-mg and 40-mg strengths. The drug is the generic equivalent of Pfizer's Protonix, which had U.S. sales of approximately $1.6 billion for the 12 months ended Dec. 31, 2010, according to IMS Health.

Actavis said it would distribute the drug soon.

MORRISTOWN, N.J. — Over-the-counter generic versions of a line of products used to treat congestion do not infringe on the patents covering the branded versions, a federal court ruled Wednesday.

ALEXANDRIA, Va. — Companion legislation, which seeks to change a provision in the healthcare-reform law and permit Americans to use their flexible spending accounts and health savings accounts to buy over-the-counter medications without a prescription, has the support of the National Association of Chain Drug Stores.