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FDA To Hold Two-Day Direct-To-Consumer Advertising Meeting In November 2005
Public Meeting to Review Rules Concerning Prescription Drug DTC Advertisements The FDA is considering revising rules about, first, how much side-effect risk information prescription drug commercials must include and, second, whether all direct-to-consumer ("DTC")…
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Even One Day of Vioxx Use Can Cause Heart Attack or Stroke Says Expert
Dr. Benedict Lucchesi Testifies at Humeston Vioxx Trial in New Jersey Dr. Benedict Lucchesi, a prominent heart and medication expert from the University of Michigan, told the jury hearing evidence at the Humeston Vioxx…
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Federal Authorities Investigating Suspected Fraud in Fen-phen Class Action Settlement
Some Claimants’ Lawyers May Have Submitted Bogus Heart-damage Claims The U.S. Attorney’s Office in Philadelphia and the FBI are investigating allegations of fraud in the $5 billion fen-phen class action settlement. The federal investigators…
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Two Key FDA Officials Tell IOM Panel About Their Concerns Over Current Drug-safety System
Lack Of Authority for FDA to Evaluate Safety of Drugs After Marketing Approval On June 8, 2005 Steven K. Galson, acting director of FDA’s Center for Drug Evaluation and Research (CDER), and Janet Woodcock,…
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Will Merck Settle Some of the Vioxx Cases, or Is This True Hardball?
Can Merck’s Lawyers Defend Against Each of the Thousands of Vioxx Cases? Alex Berenson, of the New York Times ("NYT"), reported that in an August 25, 2005 interview Merck’s general counsel Kenneth C. Frazier…
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Drug Companies Object to Early Warnings on New FDA “Drug Watch” Site
Will the FDA be Steadfast in Showdown with Big Pharma Over Drug Watch Plan? The FDA intends to post emerging drug-safety concerns that are being evaluated by the agency on a new "Drug Watch"…
