In his State of the Union Address Feb. 12, President Barack Obama called on Congress to avoid the harmful effects of the automatic budget cuts set to take place March 1. The sequester could result in a 5.1 percent cut to the budget of the National Institutes of Health.

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The U. S. Food and Drug Administration granted accelerated approval to pomalidomide (POMALYST® capsules, Celgene Corporation) for the treatment of patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and bortezomib, and have demonstrated disease progression on or within 60 days of completion of the last therapy. 

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The U.S. Food and Drug Administration is alerting health care professionals that an unapproved cancer medicine distributed by a U.S. company, Medical Device King (also known as Pharmalogical), is counterfeit. FDA lab tests have confirmed that at least one batch of a counterfeit version of Roche’s Altuzan distributed in the U.S. contains no active ingredient.

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The U.S. Food and Drug Administration approved doxorubicin hydrochloride liposome injection (Sun Pharma Global FZE), a generic version of DOXIL Injection (doxorubicin hydrochloride liposome; Janssen Products, L.P.) for the treatment of ovarian cancer in patients whose disease has progressed or recurred after platinum-based chemotherapy and for AIDS-related Kaposi's sarcoma after failure of prior systemic chemotherapy or intolerance to such therapy.

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The 113^th Congress is in full swing with committee assignments finalized for both the U.S. Senate (now comprised of 53 Democrats, 45 Republicans, and 2 Independents) and the U.S. House of Representatives (including 234 Republicans and 201 Democrats). Of particular interest to the oncology community are assignments to key committees that oversee federal healthcare programs and agencies.  “These committees play a crucial role in shaping the environment in which we care for patients with cancer,” said ASCO President Sandra M. Swain, MD, FACP. “We welcome the opportunity to work with newly elected members of Congress as well as lawmakers who have provided longstanding leadership in the healthcare arena.”

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On February 1, CMS announced a final rule implementing Section 6002 of the Affordable Care Act (the “National Physician Payment Transparency Program: Open Payments”). The final rule, commonly called the “Sunshine” rule, will make information publicly available about payments or other transfers of value from applicable manufacturers to physicians and teaching hospitals (“covered recipients”), and about physician (or immediate family members of a physician) ownership or investment interests in applicable manufacturers and group purchasing organizations (GPOs).

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Amid the many federal budget issues challenging all of medicine today, none is thornier, perhaps, than the sustainable growth rate (SGR) formula that perennially threatens Medicare patients’ access to critical health care and the viability of physician practices across the United States. In oncology, the turbulence and uncertainty caused by this issue has been acute.

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ASCO and the American College of Cardiology (ACC) sent a letter to President Barack Obama, urging him to prevent a triple-threat of devastating budget cuts threatened by sequestration.

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