Archive for "USDA"

“Unapproved” Morphine Remains in Market

April 10th, 2009

The U.S. Food and Drug Administration has decided to leave a liquid form of morphine on the market for terminally ill patients, even though the drug officially has not been approved. “While the FDA remains committed to ultimately ensuring that all prescription drugs on the market are FDA approved, we have to balance that goal with flexibility and compassion for patients who have a few alternatives for the alleviation of their pain,” Dr. Douglas Throckmorton, deputy director of the FDA’s Center for drug Evaluation and Research, said Thursday. The federal agency made its decision after consulting with hospital and hospice organizations, which feared that taking the product off the market would result in hardship for terminally ill patients and their caregivers, CNN reports. Thus, the agency decided to extend the usage of morphine sulfate oral solution 20 mg/ml. The FDA did not want to leave sick patients without a comparable alternative while they wait for something to be approved, according to CNN. “In light of the concerns raised by these patients and their health-care providers, we have adjusted our actions with regard to these particular products.”

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Health News: Congressional Democrats Drop Child Health Bill; Free Drug Samples Could Cost Uninsured More; Natural Label No Guarantee

September 8th, 2008

Congressional Democrats drop child health bill. Congressional Democrats have scrapped plans for another vote on expansion of the Children’s Health Insurance Program. The move spares Republicans from a politically difficult vote just weeks before elections this fall, the Washington Post reports. Before the summer recess, Democrats had vowed repeatedly to force another vote on the popular program. But Democrats say they have shifted course, after concluding that President Bush would not sign their legislation and that they didn’t have the votes to override a veto. Mr. Bush vetoed two earlier versions of the legislation, which he denounced as a dangerous step toward “government-run health care for every American,” and the House sustained those vetoes.  The move effectively shelves the legislation, which was aimed at expanding state health care coverage for  poor and middle-income families, is effectively dead for now. “We are not going to change any votes on the children’s health insurance bill. We still don’t have enough to override a veto,” said Rep. Rahm Emanuel (D-Ill.), chairman of the House Democratic Caucus. “Those who opposed this bill can face the voters and explain why they believe 10 million kids should not get health coverage.” 

Free drug samples could cost uninsured more. Free drug samples provided to physicians by pharmaceutical companies could actually be costing uninsured patients more in the long run, according to a study done by researchers at Wake Forest University Baptist Medical Center and colleagues. The retrospective study looked at the prescribing habits of more than 70 physicians in a university-affiliated internal medicine practice in the months immediately before and after the closing of their drug sample closet. The results indicate that the availability of free samples from pharmaceutical companies greatly impacts whether an uninsured patient is given a prescription for a generic or a brand-name drug. The complete findings can be found in the September issue of Southern Medical Journal. “It’s true that samples can save patients money in the short-run,” said David P. Miller, M.D., lead researcher and internal medicine physician at Wake Forest Baptist. “But our study shows that they may end up paying more in the long run when they are given prescriptions for brand-name only drugs.” After looking at 2,000 cases, researchers found that, for uninsured patients, the percentage of medications prescribed as generics rose from 12 percent to 30 percent after the clinic closed its drug sample closet. For Medicaid patients, however, there was no significant change in generic prescribing.
Natural label is no guarantee. The word “natural” on a food label sounds like it might mean the food is better for you, but a University of Missouri nutritionist says that isn’t necessarily the case. “The United States Food and Drug Administration (FDA) sets standards for the nutrition information and health claims that can be made on a food label,” said Tammy Roberts, nutrition and health education specialist with University of Missouri Extension. “Claims made on food labels are to be truthful and not misleading. Still, it’s easy for some claims to be confusing.” The three terms that many people are confused about are “natural,” “healthy” and “organic,” Roberts said. “Many people think they all mean about the same thing, but there are different specific meanings for all of these terms,” Roberts told U.S. News & World Report. When a food is labeled as “natural,” it means that the product does not contain any synthetic or artificial ingredients or is minimally processed. According to Roberts, the food label should explain how the producer is using terms such as “no added colorings” or “no added artificial ingredients” along with the “natural” claim. For a food to be labeled as “healthy,” it must meet certain criteria for the amount of fat, saturated fat, cholesterol and sodium and have specific minimum amounts of vitamins, minerals or other beneficial nutrients. If a food is labeled as “organic,” it must meet standards set by the U.S. Department of Agriculture in the way the food is grown or produced. “It is important to note that USDA makes no claims that organically grown food is more nutritious or safer than other non-organically produced food,” said Roberts.

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