Regulatory and Washington

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.

ATLANTA — The Centers for Disease Control and Prevention measured a steady rise in influenza — both in number of cases and severity — for the week ended Feb. 5.

There are 19 states that now are experiencing high levels of influenza-like illnesses as measured by outpatient visits — a measuring stick that provides a sense as to how severe the flu might be in a community but not how prevalent it is. The proportion of outpatient visits for ILI was 4.6%, which is above the national baseline of 2.5%.

SILVER SPRING, Md. —The Food and Drug Administration announced Friday the approval of Waltham, Mass.-based Thermo Fisher’s QMS Everolimus Immunoassay, a test that monitors the blood for levels of Novartis’ drug Zortress (everolimus).

Zortress is a drug used to prevent rejection of transplanted kidneys.

“QMS Everolimus is the first FDA-cleared test physicians can use to maintain appropriate levels of the immunosuppressant everolimus,” FDA Center for Devices and Radiological Health director Jeffrey Shuren said.

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.