The Regulation Atmosphere

The pharmaceutical industry is cautiously optimistic that the new Bush administration and Congress will continue efforts to streamline the drug discovery and approval process. But the federal regulatory and licensing landscape will also be shaped this year by patent reform and gene therapy issues. In addition, two major pieces of legislation--one affecting drug approval times and the other market exclusivity--will either be phased out or reauthorized in the coming 18 months.

"We really can't say much about where the [Food and Drug Administration] may be headed under the Bush administration" until a new commissioner is named, says Jeff Trewhitt, spokesperson for the Pharmaceutical Research and Manufacturers of America (PhRMA). But he believes the American public is "pretty comfortable" with current drug standards and procedures, and notes that the drug industry is not seeking major changes to the process. The industry is heartened by the Republican National Committee's party platform,...