On July 31, 2013, the United States Department of Justice announced that Wyeth Pharmaceuticals pleaded guilty to misbranding a drug and agreed to pay $490.9 million to resolve criminal and civil liability. The drug in question, Rapamune, was approved by the FDA in 1999 for use in preventing the body’s immune system from rejecting kidney transplants. Wyeth, however, allegedly trained its U.S. sales force to promote the drug for use in transplants of other organs, something that is ...
continue reading...Wyeth Pharmaceuticals Pleads Guilty to Criminal Misbranding of Rapamune
Posted December 27, 2013 in Product News and Recalls
FDA Officially Bans Use of BPA in Baby Bottles and Cups
Posted December 27, 2013 in Product News and Recalls
The New York Times reports that a recent statement issued by the Food and Drug Administration officially prohibits the use of BPA in baby bottles and children’s cups.
Bisphenol A, known commonly by its acronym BPA, is a synthetic compound that is commonly used in plastic. Although the F.D.A. declared BPA safe in 2008, concerns arose regarding potential health risks in 2010.
The F.D.A.’s recent statement was largely prompted by the American Chemistry Council, which states that this is partly ...
continue reading...FDA To Expand Authority Over Drug Compounders
Posted December 26, 2013 in Drug and Medical Device Lawsuits | Product News and Recalls
Recently, the FDA advocated to expand authority over drug compounders due to a recent increase in public health risks caused by these facilities.
Traditional compounding pharmacies have been used for over a century to provide a customized prescriptions for patients. A recent trend, however, is that these compounders have started acting as large-scale manufacturers for medical facilities across the country, raising new concerns about safety and proper regulatory oversight.
An editorial in USA Today describes one of these ...
continue reading...Greater Scrutiny of Prescription Drug Studies May Help Reduce Injury
Posted December 23, 2013 in Drug and Medical Device Lawsuits | Product News and Recalls
Should pharmaceutical companies make their clinical research public? A recent New York Times article discussed this very question. Although many consumers believe that any drug that was approved by the FDA is safe, clinical studies are sometimes manipulated in a rush to get a “blockbuster” drug to market. Researchers and courts have also noted that the FDA is severely understaffed to properly review thousands of pages for thousands of drug applications. Without access to clinical trial data, independent researchers are ...
continue reading...FDA Limits Arsenic In Apple Juice
Posted December 20, 2013 in Product News and Recalls
In welcome news to parents, the Food and Drug Administration has decided to set a new limit to the level of arsenic allowed in apple juice.
The FDA is setting in place a strict standard on how much arsenic is acceptable in apple juice, limiting the amount to the same level currently permitted in drinking water. According to an article in the Los Angeles Times, this change comes after a Consumer Reports analysis on levels of the potentially poisonous metal ...
continue reading...GlaxoSmithKline Comes Under Investigation for Corruption by Chinese Officials
Posted December 18, 2013 in Product News and Recalls
According to the website of China’s Ministry of Public Security, executives of GlaxoSmithKline’s operations in China confessed to charges of bribery and tax law violations. The Ministry detailed more than $489 million worth of bribes to government officials, medical associations, hospitals, and doctors to boost sales and prices. China’s official newspaper, the People’s Daily, and the Xinhua news agency both reported that Glaxo collaborated with more than 700 travel agencies and consultancies over a six year span to bribe doctors ...
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