title: AMCP Seeks an End to 20 Years Of Confusion Over FDAMA Section 114.
abstract: The FDA never issued regulations to clarify the boundaries of promotion of pharmacoeconomic data, something it's been dragging its feet on for nearly 20 years. In turn, pharma companies, fearful of being penalized for off-lable promotion, have erred on the side of caution, hesitating to take advantage of Section 114.
authors.forename: Michael D
authors.initials: MD
authors.lastname: Dalzell
mesh_terms: D004345:Drug Industry / Q000191:economics* / Q000331:legislation & jurisprudence*; D017850:Economics, Pharmaceutical; D006801:Humans; D008329:Managed Care Programs / Q000191:economics* / Q000331:legislation & jurisprudence*; D010593:Pharmaceutical Services / Q000191:economics* / Q000331:legislation & jurisprudence*; D014481:United States; D014486:United States Food and Drug Administration