Generics

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.

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.

CHICAGO An investigational drug made by Johnson & Johnson is more effective in reducing the risk of stroke in patients with a trial fibrillation than a widely available generic, the drug maker said Monday.

J&J announced results of the phase-3 “Rocket-AF” trial of rivaroxaban, saying results showed that a once-daily dose of the drug worked better than warfarin, the most commonly used drug for preventing stroke in AF patients. Rivaroxaban also was comparable in terms of safety.

NEW YORK — A ghost from 2008 soon could come back to haunt 2010.

According to published reports, the Food and Drug Administration may be considering adopting tougher standards for certain classes of generic drugs if it determines that some are not equivalent to their branded counterparts.

NEW YORK — Look for a big surge in brand-to-generic drug switches at the pharmacy counter over the next year.

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.

WHAT IT MEANS AND WHY IT'S IMPORTANT — Retail pharmacies scored a big victory in the Centers for Medicare and Medicaid Services rule, which puts the kibosh on pricing policies that would have severely affected retail pharmacies' ability to make money from generic drugs, and thus forced them to turn away Medicaid patients.

ALEXANDRIA, Va. The National Association of Chain Drug Stores and the National Community Pharmacists Association heralded the withdrawal of two provisions from the Medicaid program that would have had retail pharmacies selling generic drugs at a loss.