October 8, 2012 |
Almost a quarter of prescription medications approved for patients in Canada over a 16-year period went on to be pulled from the market or to require a strongly worded safety warning to patients, a new study says. In a " Research Letter " published online in the Archives of Internal Medicine, University of Toronto researcher Dr. Joel Lexchin looked at the 434 drug approvals that moved through Health Canada's drug-safety arm from the start of 1995 to the end of 2010. Canada's drug safety agency operates much like the U.S. Food and Drug Administration, so the study may reflect the state of drug safety in the United States as well.
October 5, 2012 |
The Food and Drug Administration took a highly unusual step this week: It acknowledged that a widely used generic drug -- a copycat of the antidepressant Wellbutrin XL -- was not the equivalent of the original drug produced by GlaxoSmithKline since 2003. The move prompted the world's largest manufacturer of generic drugs, Israel-based Teva Pharmaceuticals, to stop shipping its generic extended-release bupropion -- marketed as Budeprion 300 mg XL-- and to remove it from U.S. shelves.
March 5, 2012 |
The congressional legislators who oversee the Food and Drug Administration and control the nation's coffers have shown again that they neither understand drug development nor the regulatory problems that plague it. In February, Sen. Barbara A. Mikulski(D-Md.) unveiled a bipartisan bill intended to spur innovation in research and drug development for chronic, costly health conditions such as Alzheimer's disease, cancer, diabetes and heart disease. According to the press release, the bill will invest "in public-private partnerships to ensure scientists and researchers are able to develop new safe and effective drugs," shrink product development timelines, increase the number of drugs in the development pipeline and expedite the FDA review process.
January 26, 2012 |
A new proposal to toughen the Food and Drug Administration's power to regulate dietary supplements has the makers of vitamins, minerals and botanical extracts up in arms. But an editorial in the New England Journal of Medicine says the drug-safety agency's proposed new powers do not go nearly far enough. To expand its current $28-billion-a-year market, the dietary supplements industry is widely devising and selling formulations that use "novel" products -- minerals, plants, or amino acids that appear newly promising, which have not circulated widely in the United States before, or which are offered in "mega-doses" much higher than have been customarily used in supplements.
October 8, 2010 |
Abbott Laboratories said Friday that it would withdraw the diet drug Meridia at the request of the U.S. Food and Drug Administration, less than a month after it failed to win over one of the federal agency's safety advisory panels. The FDA confirmed the Chicago drug giant's decision, saying Abbott withdrew the drug because of "clinical trial data indicating an increased risk of heart attack and stroke. " The withdrawal of Meridia, also known by its scientific name sibutramine, leaves just one U.S.-approved diet drug on the market: the prescription Xenical.
December 11, 2009 |
Expanding access to low-cost prescription drugs from overseas might look like a sure winner in the effort to make healthcare more affordable. President Obama supports the idea, as do many Democrats and several Republicans. But the seemingly popular proposal brought the Senate healthcare debate to a standstill Thursday, as Democrats divided over whether they should bow to the drug industry's fierce opposition. Majority Leader Harry Reid (D-Nev.) temporarily halted consideration of the healthcare bill after three days of inconclusive debate on an amendment by Sens.