Regulatory and Washington

ALEXANDRIA, Va. — The National Community Pharmacists Association on Wednesday submitted a statement for the record to the U.S. House Energy and Commerce Health Subcommittee for its hearing on “Fostering Innovation to Fight Waste, Fraud and Abuse in Health Care.” NCPA’s statement called for pharmacy audits to focus on true waste, fraud and abuse as opposed to clerical errors, and for policymakers to examine mail-order waste in federal health programs. 

The battle over "pay for delay" continues to heat up, and its resolution likely won't come until the nation's highest court decides on the legality of the practice.

ALEXANDRIA, Va. — The National Community Pharmacists Association on Wednesday commended a bipartisan push for the Government Accountability Office to review the impact on patients of sharp reductions in reimbursement for diabetes test supplies provided by community pharmacies to Medicare beneficiaries. 

NEW YORK — The Electronic Retailing Self-Regulation Program on Monday recommended that Lunada Biomedical discontinue weight-loss and other claims made for Amberen, a dietary supplement marketed to menopausal women. ERSP found, however, the company could support claims related to hot flashes, irritability, sleeplessness and “low libido.”

NEW YORK — A state Senate committee in Tennessee is looking into the possibility of allowing supermarkets to sell wine, according to published reports.

The Memphis, Tenn., Commercial Appeal reported that the proposed law would be subject to approval in local referendums.

Supporters of the bill cited convenience, while opponents — including liquor store owners — said it would be detrimental to public health, safety and the economy, criticizing the legislation as driven by "big national chains" and harmful to locally owned businesses.

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug for postmenopausal women who experience pain during sex.

The agency announced the approval of Shionogi's Osphena (ospemifene) for women with moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy due to menopause associated with declining levels of estrogen hormones.

LANSING, Mich. — The federal government has recognized the state of Michigan as a national leader in electronic prescribing, a group of health organizations in the state said.

The Michigan Health Information Network said that the Office of the National Coordinator for health information technology had commended it, recognizing that 94% of pharmacies in the state are equipped for e-prescribing.

NEW YORK — Drug maker Ranbaxy Labs has started producing the ingredients for a cholesterol drug while working with the Food and Drug Administration to fix manufacturing issues that led to the recall in November 2012 of several batches of the drug.

The Indian drug maker said it had initiated corrective and preventive actions, or CAPA, as it prepared to resume supplies of generic atorvastatin calcium tablets to the U.S. market. The drug is a generic version of Pfizer's Lipitor, and Ranbaxy became the first company to market a generic version in November 2011.