FDA control of tobacco may reshape industry

Source: money.cnn.com Author: Associated Press If legislation passes to give the Food and Drug Administration the authority the regulate the tobacco industry, it could reshape the industry's competitive landscape, Fitch Ratings said in a new report Thursday. The U.S. House overwhelmingly passed the legislation in July, but it requires approval by the Senate and President Bush. Bush's administration has said he will veto the bill. The bill would empower federal public health authorities to regulate tobacco for the first time. Fitch said it does not expect the law to be put into practice this year but said that if a Democrat is elected to the White House, the eventual passage of the bill is "highly probable." Analysts have said Richmond, Va.-based Philip Morris USA stands to benefit if the FDA receives the authority to regulate the tobacco industry. Experts have said the measure _ which is favored by PMUSA-owner Altria _ would benefit Altria because the greater restrictions could solidify its position as the market leader and owner of the Marlboro brand. Fitch believes more rules on how to advertise and promote cigarettes would reduce competition and benefit the companies with bigger market shares. The nation's second-biggest cigarette maker, Reynolds American Inc.'s R.J. Reynolds Tobacco Co., has said it opposes the bill. Altria, Reynolds and others are already expanding the number of non-cigarette products they sell, such as cigars, pouchlike snus and snuff. Fitch Senior Director Wesley Moultrie II said any such law could lead to further consolidation as smaller [...]

Fight Against Cancer: Patient vs. Process

Why One Cancer Patient Is Fighting a Drug Company Working on a Cure Source: abcnews.go.com Author: John Donovan On this relatively good morning in the course of her mom's inoperable cancer, Jackie Loughman, of Indianapolis, knows some facts about pain that she wishes she didn't. "She is mostly in bed and in pain all the time, and, you know, it is hard to watch," Loughman said of her mother, Connie. But the fact really throwing Jackie and Connie is that there is a drug out there that has saved at least one pancreatic cancer patient — and Connie can't get it. Richard Jordan, a Colorado landscaper, was supposed to be dead by now, but he got into a trial for the drug TNFerade. His wife called it "a miracle." Jordan's oncologist, Dr. Raj J. Shah of the University of Colorado, said, "The remarkable thing of his story is that he went on to surgery — but more importantly, when they removed the mass, no cancer was left or seen. With pancreatic cancer, the complete response is really rare." Connie is disqualified from the TNFerade trial by her participation in an earlier trial for a different drug that she says made her sick. TNFerade is made in Maryland by a small firm called GenVec, which told Jackie and ABC News in a statement: "We are working aggressively to advance our product candidate, TNFerade, through the required clinical studies and regulatory review process. ... Unfortunately, this process makes it impossible for GenVec [...]

FDA News Impacts Cancer Patients

Source: National Anemia Action Council (www.anemia.org) Author: staff The U.S. Food and Drug Administration (FDA) ordered specific changes for the use of erythropoeisis-stimulating agents (ESAs) to treat anemia in patients receiving chemotherapy. The label changes will state treatment should only begin when a patient’s hemoglobin level drops to 10 g/dL and removes the mention of 12 g/dL as an upper hemoglobin level of treatment because the safety of ESA use at that level is not yet known. The labeling will also advise not to use ESAs when chemotherapy is given to cure patients, which based on a doctor’s discretion, could include treatment designed to prevent cancer from coming back. The announced label changes reflect most of the recommendations from the Oncology Drugs Advisory Committee’s meeting March 13, 2008. Not included is advice from the committee to limit use of the drug for patients with breast cancer or head and neck cancer, despite recent studies showing more rapid tumor growth or shortened survival when these patients received treatment with ESAs. The drug’s manufacturer, Amgen, announced the revised product labeling for ESAs will be released to both physicians and patients soon. The FDA and Amgen agreed on a majority of the new label, but could not reach agreement on a couple points, prompting the FDA to invoke new authority to mandate drug label changes.

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