Category: FDA Drug Safety Oversight
-
FDA Warning Letters About Misleading DTC Ads Tripled During Last Year
Most Common Offense is De-emphasizing Serious Side Effect Risks in Advertisements On September 19, 2005 Thomas Abrams, head of FDA’s Division of Drug Marketing and Communications, told food and drug regulatory lawyers attending a…
-
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")…
-
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,…
-
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"…
-
Propulsid: Blockbuster Drug With Danger Signals That Were Ignored
FDA’s Failure to Act in 1998 Foreshadowed Its Later Mishandling of Vioxx and Bextra A June 2005 article in The New York Times ("NYT") by Gardiner Harris and Eric Koli provided insight about how…
-
New Drug Safety Panel Will Mean More FDA Scrutiny of Drugs Already on Market, But Perhaps Not Enough
Congress Should Give FDA Authority to Impose New Labeling Language on Approved Drugs Without Needing Big Pharma’s Permission When Health and Human Services (HHS) Secretary Michael Leavitt was announcing the new Drug Safety Oversight…
-
Abbott’s Weight-loss Drug Meridia Gets a Confidence Vote by FDA
FDA Denies Public Citizen’s Petition to Remove Meridia from Market The FDA has decided that the benefits of Abbott Laboratories’ prescription weight-loss drug Meridia continue to outweigh the drug’s risks for select obese…
-
Crawford & Co. Go on Tour: FDA Road Show Will Visit Miami, Boston, and Phoenix
"Vision 2006" Public Meetings to be Hosted by FDA Commissioner Lester Crawford According to news reports published August 16, 2005, Lester Crawford, the new head of the FDA, will be putting on a series…
-
FDA Drug Safety Panel Member Composition Is Criticized by Senator Grassley and FDA’s Graham
Concern About Panel’s Independence May Create Support for Pending Grassley-Dodd Bill Due in large part to the types of people who have been appointed as members , Senator Charles E. Grassley (R-Iowa) and FDA…
-
FDA Chief Dr. Lester Crawford is Criticized on Drug-safety Issues
Vioxx Case Puts Spotlight on FDA’s Monitoring of Emerging Drug Side Effects At a July 26, 2005 hearing before a House of Representatives appropriations subcommittee, Dr. Lester Crawford, the new head of the FDA,…