PHARMACY

President Obama releases new healthcare-reform proposal, NCPA responds

BY Allison Cerra

ALEXANDRIA, Va. An organization representing the nation’s independent pharmacies responded Monday to a new White House healthcare-reform proposal.

President Obama released his own detailed healthcare-reform proposal Monday, which would cost $950 billion over a 10-year period and addresses some of the main concerns of House leaders who are demanding more help for the middle class. The President’s proposal also “includes provisions to crack down on waste, fraud and abuse.” In response to this, the National Community Pharmacists Association’s EVP and CEO Bruce Roberts, commended President Obama and congressional members for improving the U.S. healthcare system and looks forward to continued collaboration with the government to aid community pharmacists in providing patients with better health outcomes at a lower cost.

While NCPA expressed their support of fighting waste, fraud and abuse in Medicare and Medicaid, the organization warned that government officials should “take care to avoid inadvertently restricting patients’ access to legitimate health services as they pursue initiatives such as Medicaid Prescription Drug Profiling. The problematic pharmacy accreditation requirement in Medicare’s durable medical equipment program is a prime example.”

Roberts added, “NCPA appreciates that the President’s proposal is offered as an addition to the Senate-passed health reform legislation. That bill includes a number of policies that community pharmacists support. Namely, an equitable fix to Medicaid’s average manufacturer price reimbursement formula for generic drugs; an exemption for most community pharmacies from Medicare’s onerous, costly accreditation requirements for sales of diabetes testing supplies and related goods; limited disclosure requirements for pharmacy benefit managers; and an expansion of medication therapy management programs.”

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Watson seeks FDA approval for depression generic

BY Alaric DeArment

MORRISTOWN, N.J. Watson Pharmaceuticals has filed a regulatory approval application with the Food and Drug Administration for a generic drug to treat depression, the generic drug maker announced Monday.

Watson filed an application for bupropion hydrobromide tablets in the 174-mg and 348-mg strengths through its subsidiary, Watson Labs Inc.-Florida. The drug is a generic version of Biovail’s Aplenzin ER, used to treat major depressive disorder.

Because Watson filed its application prior to the expiration of Biovail’s patents, Biovail filed suit against Watson Thursday in the U.S. District Court for the District of Delaware. Under the Hatch-Waxman Act of 1984, the suit places a stay of final FDA approval on Watson’s version of the drug for up to 30 months or until the two companies resolve the matter before the court.

Watson said it may be the first company to file for approval of a generic version of Aplenzin, which would allow it to compete directly with the branded version of the drug for six months following patent expiration, which will occur in 2026, according to FDA records.

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Rituxan gets nod of approval from FDA

BY Alaric DeArment

ROCKVILLE, Md. The Food and Drug Administration has approved a drug made by Roche subsidiary Genentech and Biogen Idec as a treatment for the most common type of adult leukemia, the agency announced Thursday.

The FDA approved Rituxan (rituximab) for patients with chronic lymphocytic leukemia who are beginning chemotherapy for the first time and for those who have not responded to other CLL drugs. The drug is already used to treat non-Hodgkin’s lymphoma and rheumatoid arthritis and is the third drug to win FDA approval as a treatment for CLL, after the October 2009 approval of GlaxoSmithKline’s and Genmab’s Arzerra (ofatumumab) and the March 2008 approval of Cephalon’s Treanda (bendamustine hydrochloride).

“Rituxan with chemotherapy can delay the need for additional treatment because it significantly extends the time people with CLL live without the disease worsening,” Roche and Genentech EVP global development and chief medical officer Hal Barron said in a statement. “This approval provides an important option and new hope to the many people with this incurable cancer.”

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