Regulatory and Washington

NEW YORK — The National Advertising Division of the Council of Better Business Bureaus last week recommended that SPD Swiss Precision Diagnostics, manufacturer of the Clearblue Easy Digital home pregnancy test, modify its advertising to clarify to consumers that the test only delivers completely “certain” results on or after the day of a consumer’s expected menstrual period.

PHILADELPHIA — GlaxoSmithKline has changed prescribing information on the labeling for one of its Type 2 diabetes drugs to reflect new restrictions on the drug’s use, the drug maker said.

GSK said it revised the labeling for Avandia (rosiglitazone) to take into account the risks of heart attacks and heart failure in patients taking the drug.

The FDA moved to restrict access to Avandia last year and required GSK to create a risk evaluation and mitigation strategy for the drug.

WASHINGTON — The Department of Health and Human Services on Friday launched a new Web portal that very well could make niche marketing of pharmaceutical and over-the-counter medicines easier to execute.

The portal, called the Health Indicators Warehouse, represents a collection of health and healthcare indicators that can be parceled out by:

ALEXANDRIA, Va. — In a statement submitted to the House of Representatives Small Business Committee, the National Association of Chain Drug Stores further emphasized its support of legislation to repeal the 1099 business tax form reporting requirements. NACDS indicated that such requirements would force pharmacies to spend inordinate amounts of time and human resources on additional paperwork, leading to less time alloted to helping patients with their healthcare needs.

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.