PHARMACY

Lobbying for FMAP extension: It makes sense

BY Jim Frederick

WHAT IT MEANS AND WHY IT’S IMPORTANT Chain and independent pharmacy retailers learned a long time ago that going to bat for disadvantaged consumers in the communities they serve often can make good economic sense, as well as make them good corporate citizens. Their current campaign to convince Congress to extend the temporary federal boost in medical assistance for lower-income Americans hit hard by a brutal recession is a perfect case in point.

(THE NEWS: Pharmacy groups seek federal medical assistance percentage extension. For the full story, click here)

Five national pharmacy and retail groups – the National Association of Chain Drug Stores, National Community Pharmacists Association, American Pharmacists Association, Food Marketing Institute and National Alliance of State Pharmacy Associations – have joined forces to plead with the Senate for continued indirect relief for those Americans. Their goal: to convince federal lawmakers to pass legislation that would extend the additional medical assistance funding now going to programs like Medicaid that provide a health safety net for the millions of long-term or recently unemployed or underemployed Americans and their dependents.

The program is called FMAP, for federal medical assistance percentage. Created under the American Recovery and Reinvestment Act, it opened a wider funding spigot for states staggered by the recession and the resulting loss of tax revenues, allowing them to continue providing their share of health benefits to lower-income people through such programs as Medicaid.

All well and good, considering the enormous burden the financial meltdown has put on tens of millions of Americans. But FMAP, as currently written, is set to expire at the end of calendar 2010. And it’s increasingly apparent that states will continue to reap the bitter harvest of this recession long after that expiration date as they struggle to make up drastic funding shortfalls.

Indeed, NACDS and the other pharmacy groups pushing for an extension of FMAP predict the state budgetary crisis will continue to plague state-administered medical assistance programs for at least two more years, “with state budget deficits approaching $180 billion.” Their answer, contained in a June 8 written plea to Senate majority leader Harry Reid, D-Nev., minority leader Mitch McConnell, R-Ky., and other top lawmakers, is straightforward: extend the program for another six months, through June 30, 2011.

It goes without saying that serving as a champion for hard-hit healthcare consumers is both an altruistic gesture and a solid way for pharmacy retailers to build long-term gratitude and loyalty among those consumers. But lobbying Congress for an extension of FMAP also makes good business sense. Pharmacy leaders are, in essence, assuring the economic viability and ongoing market support of those customers.

“We strongly believe,” the pharmacy groups told Reid and McConnell, “that extending the current FMAP increases, as part of the tax extenders legislation or as standalone legislation, is critical to serving the healthcare needs of some of our most vulnerable citizens, and to assist states grappling with enormous budget challenges.”

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PHARMACY

Roxane gets nod for generic herpes treatment

BY Alaric DeArment

COLUMBUS, Ohio The Food and Drug Administration has approved a generic version of a drug for herpes made by Roxane Labs, Roxane said Wednesday.

The FDA approved Roxane’s valacyclovir hydrochloride tablets in the 500-mg and 1-g strengths. The drug, which is a version of GlaxoSmithKline’s Valtrex, is used to treat genital herpes, cold sores and herpes zoster.

Valacyclovir hydrochloride tablets in the 500-mg and 1-g strengths had sales of $2.13 billion in 2009, according to IMS Health.

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GPhA responds to FTC’s attempt to quash ‘pay-for-delay’ deals

BY Alaric DeArment

WASHINGTON The Federal Trade Commission again is going after settlements between branded and generic drug companies that it calls anticompetitive, the agency said.

In testimony Wednesday before the Senate Judiciary Subcommittee on Antitrust, Competition Policy and Consumer Rights, FTC chairman Jon Leibowitz spoke of the FTC’s goal of eliminating the patent settlements, which it derides as “pay-for-delay” deals. “Years of experience have proven that competitive markets work better than anything else to bring consumers lower prices, greater innovation and more choices among products and services,” Leibowitz said.

In a typical patent settlement scenario, a generic drug company will challenge a brand company’s patent on a drug by filing a regulatory approval application for a generic version with the Food and Drug Administration containing a Paragraph IV certification. Provided for under the Hatch-Waxman Act of 1984, the law that created an abbreviated approval pathway for generic drugs, a Paragraph IV certification is a legal assertion that the patent is invalid, unenforceable or won’t be infringed by a generic version of the drug.

The brand drug company typically will respond with a patent infringement suit, and often, rather than going to trial, the two companies will reach a settlement whereby the generic drug company agrees to hold off launching its version in exchange for the brand company paying money or agreeing not to launch an “authorized generic,” essentially the branded drug sold under its generic name at a discount. But in most cases, the settlements allow the generic company to launch its version months, or even years, ahead of the patent expiration.

The Generic Pharmaceutical Association, an industry lobbying group that has long criticized the FTC on the issue of patent settlements, lashed out at Leibowitz’s testimony. “Following the testimony today by commissioner Leibowitz before a Senate judiciary subcommittee, GPhA feels compelled to set the record straight,” GPhA president and CEO Kathleen Jaeger said. “The fact is that it is patents, not settlements, that protect the brands from generic competition. Despite claims to the contrary, settlements actually help bring affordable generic medicines to market sooner, to the benefit of consumers and the healthcare system.”

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