Fda

Re your Sept. 8 editorial on the threats to the Food and Drug Administration: Not only is the legislation and the president's proposal to cut the funding for the FDA a threat to our nation's health, but also the idea of having private firms that manufacture medical devices assess their safety. I live in a retirement community where many people's quality of life depends on the use of wheelchairs, walkers and electrical vehicles. The malfunction or poor quality of these devices can have serious results to those who depend on them.

David Willman's report on FDA policies (Dec. 20) correctly analyzes the many difficult issues and conflicting pressures the agency faces in regulating the approval of new drugs. Missing from this analysis, however, is the not inconsiderable pressure the agency has had from Congress to let down the barriers and to speed up the approval process. Following the 1994 conservative revolution, Dick Armey, Tom DeLay, Newt Gingrich and their ilk harassed David Kessler and other FDA administrators to desist from "impeding progress."

La Preferida Inc. is voluntarily recalling 56,808 29-ounce cans of La Preferida Whole Pinto Beans, the U.S. Food and Drug Administration announced Thursday. "The manufacturer's preliminary inspection indicates 420 cans may not have been fully processed, which could result in product contamination by spoilage organisms or by pathogens, which could lead to illness if consumed," the FDA said. "To date, there have been no reported injuries or adverse events associated with the consumption of this product.

The Food and Drug Administration, citing safety concerns, has called on manufacturers of the drug Ambien and its generic equivalents to lower the standard dosages of the insomnia drug now sold, and it is warning physicians that at current dosages, some patients are at risk of impairment in the morning. The agency cited new data showing that the morning after taking the medication, some patients continued to have blood levels of zolpidem, the active ingredient in Ambien, that could disrupt driving and other activities that require alertness.

The Food and Drug Administrationon Friday posted additional adverse event reports connecting two more energy drinks to 53 illnesses, five deaths and two chronic disabilities. The new information comes on the heels of an FDA announcement linking the extremely popular 5-Hour Energy shots to 92 sicknesses and 13 deaths. The latest reports do not prove that the drinks -- Monster Energy and Rockstar Energy -- caused the illnesses or deaths, but rather register the fact that a doctor, family member, or patient believes the product might have played a role.

Medical innovation saves lives, but each drug and device requires careful scrutiny by the Federal Drug Administration before being deemed safe to market. But does the federal agency take too long in its approval process? Dr. Josh Makower says yes. The consulting professor of medicine at Stanford University co-wrote a study of 200 medical technology companies and reports his findings in this column by Nicole Brochu of the South Florida Sun Sentinel . The column reads in part: "For low- and moderate-risk devices, the process to navigate the FDA took companies on average three months to two years longer for a green light than it did for a similar approval from European regulators.

The Food and Drug Administration Thursday warned physicians and patients that the intravenous antibiotic Cubicin can cause life-threatening eosinophilic pneumonia, which is marked by the accumulation of a type of white blood cells called eosinophils in the lungs. Symptoms include fever, cough, shortness of breath and difficulty breathing. Cubicin is the brand name for the generic drug daptomycin, sold by Cubist Pharmaceuticals Inc. It was approved in September 2003 for treating serious skin infections and in 2006 to treat bloodstream infections.

Invisible braces sound perfect, especially if you're an adult trying to look and act your age. But the FDA says Invisalign, which makes one type of invisible braces, failed to report information on side-effects in patients. Here's the Associated Press story detailing some patients' complaints about allergic reactions to the devices  and the FDA advisory letter . And, of course, the response from Invisalign maker Align Technology Inc. in San Jose. None of this is to say that crooked teeth should stay crooked.

The first drug that targets an underlying cause of cystic fibrosis rather than the symptoms -- essentially allowing some sufferers to live a nearly normal life -- has been approved by the Food and Drug Administration. The drug Kalydeco (also known by its generic name, ivacaftor) helps a defective protein that acts as a chloride-pump in cell membranes to function properly, restoring the proper flow of water in the body. As a result, patients' mucus-filled lungs begin to clear, making them less prone to infection and perhaps allowing them to live far beyond the age of 37 -- the current average life expectancy.

It's the Food and Drug Administration's job to regulate food labels, but it turns out the agency turns a blind eye to some of the items for sale within its own cafeteria. On a recent visit to the FDA's headquarters in Silver Spring, Md., Bruce Silverglade, legal affairs director for the nonprofit Center for Science in the Public Interest, visited the cafeteria in the hopes of picking up a quick and healthy lunch. The first half of the food-selection process was easy. Tray in hand, Silverglade waited in line with the FDA employees to choose his entrée -- and was quite impressed to see that each item had an easy-to-read nutrition label tacked next to its description.