Contributed by Jai A. Dennison| 16 January, 2005  17:11 GMT
Pharmaceutical company Pfizer is on the hot seat following its recent disclosures of heart-disease risk associated with its arthritis painkilling drug Celebrex, a warning from the FDA concerning misleading advertising for the product, and the federal agency's subsequent announcement of public hearings in February to discuss the pros and cons of the entire class of COX-2 inhibitors, which includes Celebrex.The company's shares have taken a beating on Wall Street of late, according to press reports.
Open Invitation
The U.S. Food and Drug Administration plans to discuss the benefits and risks of COX-2 non-steroidal anti-inflammatory drugs (NSAIDs) and related medicines on February 16-18, at a public meeting of its Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee.
Besides Celebrex, other drugs likely to be discussed include Bextra, naproxen (the active ingredient in Aleve) and Merck's recalled medication Vioxx. All have been the subject of numerous recent news reports concerning negative potential side effects.
The public is invited and encouraged to take part in the meeting by presenting facts, relating experiences, or offering opinions in person or in writing, according to the FDA's announcment of the meetings.
Meeting Details
Public testimony will be heard between 1:00 p.m. and 3:00 p.m. on February 17, with limited time allowed for each presentation.Those who wish to address the committees must register prior to February 4, 2005. Registration is not required for attendance.
The three-day meeting will be held at the Hilton Washington DC North, 620 Perry Parkway, Gaithersburg, Maryland. The proceedings will start at 8:00 a.m. each day. Agendas and other background materials will be posted online no later than one business day before the meeting.
Information regarding this meeting, including contact information for members of the public interested in making presentations or submitting written comments, is available online. |
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