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Biotech / Medical : Merck -- Ignore unavailable to you. Want to Upgrade?


To: Brian Malloy who wrote (1143)1/13/1999 1:11:00 PM
From: DAVID BROWN  Respond to of 1580
 
This will be a Billion dollar drug.



To: Brian Malloy who wrote (1143)1/18/1999 12:47:00 AM
From: Brian Malloy  Read Replies (1) | Respond to of 1580
 
Interesting PFE tidbit from Businessweek:

Will Pfizer (PFE) Have to Take Its Medicine?
PFIZER MAY BE WALL STREET'S FAVORITE DRUGMAKER, but the company's Viagra-boosted success hasn't kept it from running afoul of the Food & Drug Administration. Citing ''a broad range of problems related to Pfizer drug products,'' FDA drug chief Janet Woodcock has taken the unusual step of asking CEO William Steere Jr. to come in personally to discuss those problems. His visit, set for late January, may prove instructive for other drugmakers.

The FDA has already warned Pfizer about violating certain marketing rules. The trigger for summoning Steere, however, was different. In its application for the intravenous antibiotic Trovan I.V., approved in 1997, Pfizer failed to tell the FDA that the drug won't work with certain saline solutions used to deliver it. Pfizer says that while it ''should have informed the FDA,'' it hopes Steere's meeting will resolve the issues. But the talk may have implications for other drugmakers. Richard Frank, a Washington lawyer who often deals with the FDA, believes that new Commissioner Jane Henney ''is sending a message that this kind of sloppiness won't be tolerated.''

By John Carey and Amy Barrett
EDITED BY ROBERT McNATT