This week FDA regulators will review two potential blockbuster drugs from Bristol-Myers Squibb -- the rheumatoid arthritis drug Orencia and Pargluva, a treatment for diabetes. Industry observers say how the agency handles the decisions will reveal a lot about its approach to drug-safety in the post-Vioxx era. Research has raised questions about the safety of both drugs. A study released last week showed a substantially increased risk of infection for patients taking Orencia. Where is the agency headed on drug safety issues? Deputy FDA commissioner Janet Woodcock offered a clue, saying, "Our vision is that there aren't bad drugs or good drugs. Instead, some drugs run into bad problems with a small subset of people."
- see this story from the Newark Star Ledger
PLUS: Henry Miller criticizes the "culture of fear" that slows down drug approval at the FDA. Op-Ed