May 2005, Volume 35 Number 5 , p 30 - 30
© 2005 Lippincott Williams & Wilkins, Inc. Volume 35(5) May 2005 p 30 FDA moves to control label changes [DRUG NEWS: ADVERSE DRUG REACTIONS]
The FDA petitioned Congress for the authority to dictate drug label changes. Currently, the FDA has to negotiate with drug companies about changes, which can delay warnings to the public.
At a congressional committee hearing, Sandra L. Kweder, FDA deputy director for new drugs, testified that a public warning about the dangers of rofecoxib (Vioxx) was delayed because the FDA had to haggle with the drug's manufacturer, Merck & Co., about the language. Merck pulled Vioxx from the market in September because some patients taking the drug developed serious cardiac problems.
Under a new policy, the Bush administration has endorsed announcing warnings to the public before label changes are finalized. Congress is also considering ...