Branded

RARITAN, N.J. — The Food and Drug Administration has issued a complete response letter regarding a supplemental new drug application for a medication developed by Janssen Research and Development.

Faced with the possibility of a critical cutoff in funding for the Food and Drug Administration, Congress moved in late May to reauthorize the Prescription Drug User Fee Act that provides the bulk of the agency’s resources for new-drug review and approval. 


Drug Store News recently talked with COPD Foundation founder and president John Walsh about the organization’s new leadership. In March, the COPD Foundation took over leadership for Drive4COPD, which aims to screen people for chronic obstructive pulmonary disease, a collective term for emphysema and chronic bronchitis, which the group estimates to affect 24 million Americans who may have it but don’t know it.


DSN: What led the COPD Foundation to take over Drive4COPD?


The Food and Drug Administration has approved a branded acne drug made by Ranbaxy Labs, the drug maker said. Ranbaxy announced the FDA approval of Absorica (isotretinoin), a drug for treating severe recalcitrant nodular acne. The company expects to launch it in the United States in fourth quarter 2012 under an agreement with Canada-based Cipher Pharmaceuticals.


In 2008, an investigation by the Associated Press revealed that drinking water supplies in major cities and metropolitan regions across the country are riddled with pharmaceutical compounds. For 41 million Americans, it suggests water with something extra means more than just a slice of lemon, though the quantities of pharmaceutical compounds in the water are too small to constitute a medical dose, according to the report.


While the picture of a new Rx-to-OTC switch paradigm is being painted with a broad stroke brush, already there are two divergent pathways emerging around what that new paradigm landscape might look like. 


OTC manufacturers have been framing the new paradigm within the existing two-drug-class system, suggesting that the diagnostic tools that already are available in the marketplace significantly could help expand which medicines are considered appropriate in the OTC space.


Retail pharmacists, on the other hand, are advocating for the creation of a third class of drugs.


WASHINGTON — Legislation proposed in the House of Representatives would speed up Food and Drug Administration approval of knock-off versions of vaccines and other biologics while requiring the agency to conduct more inspections of drug factories overseas, according to published reports.

Specialty and biologically engineered medicines have been a boon to millions of Americans with life-threatening and life-altering conditions. But their lofty prices are squeezing patients and payers and spawning a growing legislative backlash that threatens insurers and employer-based health plans.

“The imperative to find cost-effective alternatives to biologics reflects the growing demand for these specialty drugs,” IMS Health noted. “Since their origins in the 1980s, biologics have prospered into a U.S. $138 billion market [in 2010].”