House Floats Plan To Speed Drug Approvals

The leaders of the House of Representatives Energy & Commerce Committee released a draft bill last week that would overhaul the Food & Drug Administration in an attempt to get new drugs and medical products to patients faster. The effort, called the 21st Century Cures initiative, has been in the works since last spring under the leadership of Reps. Fred Upton (R-Mich.), committee chairman, and Diana DeGette (D-Colo.). The draft includes ideas from both Republicans and Democrats in Congress, as well as health care providers, drug companies, regulators, and researchers. DeGette says she does not endorse the bill in its current form but remains optimistic that a reform measure will pass this year. “I know that with continued engagement, we can reach a bipartisan consensus to help advance biomedical research and cures,” DeGette remarks. The Biotechnology Industry Organization is praising the proposal, particularly its focus on “precision medicine through genomics and regulatory science.” But the generic drug industry is disappointed, saying the bill relies too much on market exclusivity as an incentive for innovation.