BIO ridicules FDA'S off-label plan
WASHINGTON - The Biotechnology Industry Organization slammed the FDA's proposed rules on dissemination of information about off-label uses of drugs as "paternalistic and cumbersome" in comments submitted to the agency last week.
Dissemination of information about off-label uses was one of the hardest-fought conflicts in the development of legislation that became the Food and Drug Administration Modernization Act (FDAMA). Because of strong concerns by FDA that companies would distribute inappropriate material on the one hand, and adamant support among physicians and members of Congress for the distribution of scientifically sound information on the other, Section 401 of FDAMA is longer and more detailed than any other section of the bill and it is accompanied by highly prescriptive congressional report language...