Regulatory and Washington

ALEXANDRIA, Va. — The National Community Pharmacists Association on Thursday applauded the Kentucky Senate for voting to pass S.B. 107, a bill that will provide transparency regarding how pharmacy reimbursements are determined for multiple source generic drugs, and establish an appeals process when a dispute arises over those payment levels. 

ARLINGTON, Va. — Medicare and Medicaid are working with the private sector to create a roadmap for the future of healthcare delivery, and a congressional hearing was convened Thursday to ensure it does that.

The Senate Finance Committee hearing, titled "Delivery System Reform: Progress Report from CMS," included Sens. Max Baucus, D-Mont., and Orrin Hatch, R-Utah.

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.”

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.

WASHINGTON — Former surgeon general C. Everett Koop died Monday. He was 96.

Koop, who served as surgeon general from January 1982 to October 1989, was outspoken about the damaging health effects of smoking and also an early advocate of educating Americans about AIDS. In 1988, he released "Understanding AIDS," a U.S. Public Health Service brochure based on Centers for Disease Control and Prevention guidelines, which was sent to 107 million households.