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FDA to require label changes for immunosuppressant drugs

BY Alaric DeArment

ROCKVILLE, Md. The Food and Drug Administration is requiring changes to the labeling of some drugs used to prevent rejection of kidney transplants.

The FDA announced Tuesday that it would require immunosuppressant drugs to update their labels following reports of opportunistic viral infections, including BK virus-associated nephropathy, which mostly affects kidney patients and can lead to kidney graft loss.

Affected drugs include Wyeth’s Rapamune (sirolimus), Novartis’s Myfortic (mycophenolic acid) and branded and generic versions of Novartis’s Sandimmune (cyclosporine) and Neoral (cyclosporine modified) and Roche’s Cellcept (mycophenolate mofetil).

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NCPA announces new FSA service

BY DSN STAFF

NEW YORK There are a number of conclusions you can glean from the NCPA’s announcement, which runs counter to a Senate proposal to remove over-the-counter medicines as reimbursable expenses under flexible spending accounts/health savings accounts as a way to help pay for healthcare reform.

 

For example, Finpago helped quantify the value of that FSA customer. If the average pharmacy sells more than $60,000 per year in OTC products under an FSA plan, then industry wide, that means retail pharmacy captures some  $3.3 billion in FSA-related sales per year.

 

 

Pair that sales figure with the fact that 14.8% of American households have an FSA account (National Center for Health Statistics) and you get 16.5 million families saving pre-tax income dollars on some $3.3 billion in sales across more than 55,000 retail pharmacy outlets. That’s a burgeoning market of some consequence. And it’s a health benefit that has been utilized at greater rates thanks both to the inclusion of OTCs and the convenience of FSA debit cards.

 

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Washington, Mo., government votes to move PSE products to Rx-only

BY Michael Johnsen

WASHINGTON, Mo. Retailers and suppliers are again facing disparate legislation around the sale of pseudoephedrine products as more state (and now local) governments consider switching PSE products to prescription-only from their current behind-the-counter status.

Local city council for Washington, Mo., in Franklin County last week voted that PSE products can only be sold by prescription within city limits by a vote of six in favor and two opposed.

The motion was passed following a brief presentation by Sgt. Jason Grellner, commander of the Franklin County Narcotics Enforcement Unit, and Andrew Zupan, a pediatrician in favor of the switch.

The state of California is considering similar legislation; Senate bill No. 484 passed through the Senate last month but failed to pass out of an Assembly Public Safety committee as amended on June 30, though the committee will be revisiting the piece of legislation.

According to published reports, the American Civil Liberties Union of Eastern Missouri is considering legal action if the city ordinance is not repealed. “It sets a dangerous precedent,” Tony Rothert, legal director for the Missouri chapter of the ACLU told the St. Louis Post-Dispatch on Monday. “Here it’s just allergies, but next time it could be something more, like birth control.”

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