We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Wisconsin's senior drug coverage program could be extended two and a half years through a provision the state's U.S. senators included in a supplemental spending bill funding military operations in Iraq. Read More
Continuing medical education (CME) programs may not be independent from inappropriate influence from the pharmaceutical industry, Senate Finance Committee Chairman Max Baucus (D-Mont.) and Sen. Chuck Grassley (R-Iowa) said. Read More
The Centers for Medicare & Medicaid Services (CMS) is guilty of fostering a monopoly in the treatment of anemia and may also be placing the public in jeopardy through its policies, lawmakers say. Read More
Erythropoiesis-stimulating agents (ESAs) are widely used to treat patients with kidney disease and chemotherapy-induced anemia. Amgen's Aranesp and Epogen, along with Johnson & Johnson's Procrit, recorded combined sales of $9.7 billion in 2006. However, these firms have been under fire from Capitol Hill in recent months and have suffered through a round of negative publicity regarding the products. Late last year, representatives from the House Ways and Means Committee called for immediate changes to reimbursement policies for ESAs as witnesses testified that the Centers for Medicare & Medicaid Services' (CMS) current reimbursement policies promote dangerous overdosing of the drugs. In March, the FDA added a black box warning to labeling for ESAs that warns physicians to curb use of the products in patients with end-stage renal disease and chemotherapy-induced anemia. The safety issues will be discussed at the Oncologic Drug Products Advisory Committee meeting May 10, where the committee could weigh in on whether ESAs actually promote tumor growth and shorten the time to disease progression. Following the FDA announcement of the black box warning, the CMS said that it was reevaluating reimbursement policies for ESAs, in oncology and kidney dialysis settings. Because of their high cost, ESAs are in one of the classes of drugs cited by proponents of follow-on biologics. This issue of The Food & Drug Letter examines the challenges manufacturers face with these products.Read More
The FDA released a white paper saying it has the ability to approve follow-on biologics without extensive clinical trials, although some trials would be necessary for the follow-ons to replace original products. Read More
Congress will use new information from the Government Accountability Office (GAO) to decide which medical device companies will qualify as small businesses under the Medical Device User Fee and Modernization Act (MDUFMA). Read More
The Senate passed a measure easing restrictions on federal funding for embryonic stem cell research that President Bush has vowed to veto if it reaches his desk.
Two leading House lawmakers are investigating FDA Commissioner Andrew von Eschenbach’s recent testimony on Ketek over concerns that he may have “intentionally misled” a subcommittee about the drug’s approval process.
Medical device companies "overwhelmingly" accept AdvaMed's Code of Ethics on Interactions with Health Care Professionals, but they face "significant challenges" in implementing the code, according to a white paper released March 29.
Wisconsin’s ability to negotiate prices with drug manufacturers may come to an end, as the Centers for Medicare & Medicaid Services (CMS) wants the state to transform its prescription drug coverage plan for seniors into a Medicare-based program.