PHARMACY

Human Rights Campaign raises objections to Bush’s healthcare ‘conscious’ regulations

BY Alaric DeArment

WASHINGTON Regulations that would allow a healthcare professional to refuse to provide a service on the grounds of personal religious or moral beliefs have drawn criticism from a gay-rights organization.

The Human Rights Campaign criticized “provider conscience” regulations issued by the Department of Health and Human Services, saying they could be interpreted to allow healthcare professionals to deny some services to gay, lesbian and bisexual patients, such as HIV tests, also allowing them to not inform patients where else they could obtain services.

“These regulations sacrifice patients’ right to medical care, permitting providers to refuse to do their jobs when they choose,” HRC president Joe Solomonese said. “We ask the Bush administration: what happened to ‘first, do no harm?’ Denying patients legal, safe medical treatments for any reason is simply wrong, and violates the trust that all Americans, regardless of our sexual orientation or gender identity, place in our doctors, nurses, and pharmacists.”

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Biosimilars could save significant amounts in healthcare costs, report concludes

BY Alaric DeArment

ARLINGTON, Va. A report by the Congressional Budget Office on the potential savings that biosimilars could create has drawn a response from the Generic Pharmaceutical Association.

“As Congress grapples with both the economic and healthcare crises facing our nation, the CBO Budget Options Report is concrete evidence that bringing safe, effective and affordable biogenerics to patients can result in significant healthcare cost savings for the federal government,” GPhA president and chief executive officer Kathleen Jaeger said in a statement.

“Specifically, the CBO Budget Options Report states that establishing a pathway for the approval of biogenerics will result in a multi-billion dollar savings potential for the federal government.”

Currently, the law does not permit the Food and Drug Administration to approve biosimilars, sometimes called biogenerics.

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FDA approves Genzyme drug to support bone marrow transplant recovery

BY Alaric DeArment

ROCKVILLE, Md. The Food and Drug Administration has approved a drug by Genzyme that helps increase the number of blood stem cells for bone marrow transplantation in patients with certain forms of blood cancer, according to an FDA statement Thursday.

Mozobil (plerixafor) is for use with the growth factor granulocyte-colony stimulating factor for treatment of adults with multiple myeloma or non-Hodgkin’s lymphomas.

Before receiving high-dose chemotherapy or radiation therapy, patients with these forms of cancer sometimes undergo a procedure known as apheresis, in which blood stem cells are collected and stored for infusion after therapy.

Patients receive G-CSF to help release and collect stem cells from the bone marrow. When used with G-CSF, Mozobil boosts the number of stem cells released from the bone marrow into the blood stream.

“Collecting the millions of cells needed for a bone marrow transplant can take hours or days,” director of the FDA Center for Drug Evaluation and Research’s Office of Oncology Drug Products Richard Pazdur said in a statement. “Mobozil provides a new therapeutic option for patients with certain types of blood cancers by increasing the number of stem cells collected in a given time period to be reinfused after therapy.”

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