FDA & Prescription Drugs

• Two Drug Companies Criticized For Delaying Release of Trial Results

  Greg Webb | April 05, 2008 9:32 PM | 0 CommentsCharlottesville, VA

  In a critical trial of two widely used heart drugs to lower cholesterol, Zetia and Vytorin, the lead investigator has said the drugs’ manufacturers, Merck and Schering-Plough, were purposely...

• While Foreign Pharmaceutical Production Increases, FDA’s Foreign Inspection Decreases

  Greg Webb | April 05, 2008 9:27 PM | 0 CommentsCharlottesville, VA

  Heparin, a blood thinner manufactured in China, has been linked to nineteen deaths. The Food and Drug Administration (FDA) only became aware of the problem after many people became sick. The agency...

• Federal Officials Find Mystery Ingredient In Heparin—Is it a Chinese Counterfeiting Scam?

  Greg Webb | April 05, 2008 9:24 PM | 0 CommentsCharlottesville, VA

  Federal drug regulators suspect Americans might have been the victims of a lethal Chinese drug counterfeiting scheme after the mystery ingredient in certain batches of heparin was found to be an...

• Heparin Linked to More Deaths

  Michael Phelan | March 02, 2008 1:00 PM | 0 CommentsRichmond, VA

  The Food and Drug Administration reported last week that the number of deaths associated with heparin, a brand of blood thinner, has risen. The brand of heparin associated with the problems is made by Baxter International. Baxter produces most of the heparin used in the United States. Heparin is made from pig intestines, which, of course, could be supplied by U.S. farmers. Baxter buys its...

• Avandia Story Follows Predictable Pattern

  Michael Phelan | June 04, 2007 1:49 PM | 0 CommentsRichmond, VA

  From Fen Phen, to Rezulin, to Vioxx, to Avandia, the story follows a predictable pattern. The Food and Drug Administration, which currently sees itself as an arm of the pharmaceutical industry rather than a consumer protection agency, approves a drug with little more than reliance upon data provided by the drug manufacturer and advice from FDA advisory panels which are increasingly comprised of...

• FDA Warned About Avandia's Risks Seven Years Ago

  Michael Phelan | May 24, 2007 12:19 PM | 0 CommentsRichmond, VA

  Dr. John B. Buse is the chief of endocrinology at the University of North Carolina and is about to become the president of the American Diabetes Association. In 2000, Dr. Buse sent a letter to the FDA warning of the heart risks of the drug Avandia. The letter cited "a worrisome trend in cardiovascular deaths and severe adverse events" among patients using Avandia.A search of the FDA's database...

• Avandia May Increase Risk of Heart Attack

  Michael Phelan | May 22, 2007 8:56 AM | 0 CommentsRichmond, VA

  Avandia was approved by the Food and Drug Administration in 1999 to treat type 2 diabetes and is used by an estimated two million people worldwide. An article published yesterday in the New England Journal of Medicine suggests that Avandia significantly increased the risk of heart attacks and heart-related deaths. The article prompted the FDA to issue a public safety alert advising users of...

• Bush Nominee to Head CPSC Receives Payola from Manufacturers Ass'n

  Michael Phelan | May 16, 2007 2:30 PM | 0 CommentsRichmond, VA

  Michael Baroody, the senior lobbyist at the National Association of Manufacturers (NAM) nominated by President Bush to lead the Consumer Product Safety Commission (CPSC), will receive a $150,000.00 payment from NAM when he takes his new government job; a job that involves enforcing consumer laws against members of the association. Sounds like payola to me. Even Baroody characterized the...

• Senate Beefs Up the FDA

  Michael Phelan | May 11, 2007 12:13 PM | 0 CommentsRichmond, VA

  The day after Oxycontin manufacturer, Purdue Pharma, pleaded guilty to criminal charges that it fraudulently marketed Oxycontin for six years as a drug that was less prone to abuse and has fewer narcotic side effects, the U.S. Senate approved by a vote of 93-1 a landmark drug safety bill that would double the number of scientists at the FDA assigned to monitor drugs already on the market for...

• Defective Drugs & the FDA Approval Process

  Michael Phelan | March 22, 2007 1:40 PM | 0 CommentsRichmond, VA

  FDA Advisory Boards recommend drugs and medical devices for approval. Their votes can greatly effect drug company profits. Lawyers, advocacy groups, and certain members of Congress (e.g., Sen. Charles Grassley) have for years worried that the drug and device makers have hijacked the FDA's approval process by improperly influencing advisory board members through payment of exorbitant consulting...