Content about Pharmaceuticals policy

ALEXANDRIA, Va. — The Centers for Medicare and Medicaid Services has proposed a rule shortening the traditional 30-day drug cycle for long-term care centers to seven days when brand-name drugs are dispensed, prompting a supportive response from an organization representing independent pharmacies.

WALTHAM, Mass. — William Gibson, the science-fiction author who helped create the cyberpunk genre in the 1980s and paved the way for “The Matrix” movie franchise, once said, “The future is already here—it’s just not evenly distributed.”

He was correct. Emerging technologies, ranging from computers to mobile phones, historically have migrated from the theoretical to the inaccessible to the aristocratic to the indispensable and finally to the mundane.

ROCKVILLE, Md. — A backlog of more than 2,000 drug entities and devices is awaiting approval. That’s the situation facing the Food and Drug Administration and the generic pharmaceutical industry—and it’s the chief impetus behind the FDA’s push to impose user fees on generic drug makers seeking the agency’s review and approval for their brand-equivalent medicines.

LOUISVILLE, Ky. — Humana and Wal-Mart Stores on Monday announced that Mary Lee Reinscheld became the first Medicare beneficiary to sign up for the new Humana Walmart-Preferred Rx Plan at one of the Humana informational kiosks available in approximately 3,000 Walmart stores nationwide.

Reinscheld signed her Humana application at Walmart store No. 1170 here as the annual enrollment period for Medicare beneficiaries, including seniors and people with disabilities, got under way.

NEW YORK —The often wide gap between what consumers will pay out of pocket for a branded versus a generic drug is one big factor driving the continually rising demand curve for me-too medicines.

NEW YORK To express it in modern parlance, follow-on biologics will be a hot mess.

While speaking at the Reuters Health Summit, according to Reuters, Food and Drug Administration commissioner Margaret Hamburg didn’t put it quite that colorfully, but she had said the science will evolve, meaning a regulatory approval pathway never will be a truly done deal.

NEW YORK Government officials said problems have arisen with the Food and Drug Administration’s approval of a generic blood-thinning drug due to its previous relationship with the generic drug’s manufacturer, according to published reports.

MORRISTOWN, N.J. Sales for generic drug maker Watson Pharmaceuticals grew 33%, to $882.4 million, in third quarter 2010, according to an earnings report released Thursday.

The sales figure for the current quarter compared with $662.1 million in third quarter 2009. Profits were $105.9 million, compared with $90 million in third quarter 2009.

“Watson delivered another quarter of strong financial results and continued progress against our strategic objectives,” Watson president and CEO Paul Bisaro said.

SILVER SPRING, Md. The Food and Drug Administration has approved a generic treatment made by Lupin Pharmaceuticals for allergies, according to FDA records.

The drug is a generic version of Schering-Plough’s Clarinex.

Clarinex has annual sales of around $229 million, according to IMS Health data reported by several media in India, where Lupin is based.

ALEXANDRIA, Va. The National Association of Chain Drug Stores is urging federal health officials to adopt a simpler means of communicating drug safety and efficacy information to patients, and to clear the way for an approval pathway for generic versions of biologically engineered drugs.

NACDS made its priorities known in a letter Monday to Margaret Hamburg, commissioner of the Food and Drug Administration. The letter came from Kevin Nicholson, the group’s VP government affairs and public policy.