Docket Management
Docket: 00N-1665 - Consumer Roundtable; Notice of Meeting
Comment Number: EC -14

Accepted - Volume 1

Comment Record
Commentor Ms. Cindy Ploski Date/Time 2001-02-23 12:51:35
Organization Ms. Cindy Ploski
Category International

Comments for FDA General
Questions
1. General Comments The FDA should not approve the experimental plan of Discovery Laboratories to give premature babies in Latin America a placebo instead of proven lung therapy to test Surfaxin- its new experimental drug. It is unethical for this experiment to be conducted with babies who are known to have a medical problem. In Europe, the experiment does not include a placebo group and it is unacceptable to impose this on Latin America. The company must be held to an ethical and responsible standard- the experiment should compare the new drug with the existing competitor treatment that is known to be effective. -Cindy Ploski




EC -14