From Arent Fox LLP

On September 27, 2007, President George W. Bush signed into law the Food and Drug Administration Amendments Act of 2007, significantly amending the Food, Drug, and Cosmetic Act. The new Amendments will have far-reaching effects, though some of the more controversial aspects of the proposed legislation – for example, provisions involving so-called follow-on biologics - were eliminated during the extensive compromise negotiations that occurred over the past several months.

On September 27th, Representatives Anna Eshoo (D-CA) and Mike Rogers (R-MI) introduced legislation (HR Res 54) that would reverse a CMS decision limiting Medicare coverage for erythropoiesis stimulating agents (ESAs).  In July, CMS issued a "national coverage determination" announcing that Medicare would cover the use of ESAs to treat anemia caused by chemotherapy but not anemia caused by cancer.  Earlier this year, 235 House members signed a letter to CMS citing concern that the recent decision would force more cancer patients to receive blood transfusions if access to ESAs is limited which could lead to shortages in the country's blood supply.  CMS has said they will not revise their decision without additional evidence.

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In September 2007, NPAF announced the addition of four new Executive Board members including health care policy leaders and medical professionals.  All newly appointed members come to the board with a wealth of experience in the health care field where they have worked to understand the current policy landscape and the difficulties patients face in accessing care.

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On September 23rd, an editorial in the New York Times explored the issue of healthcare and its emergence as a key issue in the 2008 Presidential race.  Several Republican and Democratic candidates have released detailed healthcare reform proposals ranging from tax breaks, to subsidies, to universal coverage.  Despite all that has been said about healthcare reform in recent weeks and months, several issues have not been addressed.

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