Congress is racing to produce a panacea for all that ails us—including nettlesome barriers to investment in the pharmaceutical and medical-device sector. The 21st Century Cures Act is rapidly moving through the House Energy and Commerce Committee with bipartisan support. It’s viewed by medical professionals as the most revolutionary change to the Food and Drug Administration’s approval process since the National Cancer Act in 1971, in which Congress and President Richard Nixon declared all-out war on that dread disease.


THE MOST IMPORTANT PROPOSAL in the House bill is the required emphasis on “biomarkers” by the FDA when it is determining the efficacy of a drug or therapy. This would encourage the agency to approve a product that works in a small group of patients sharing certain genetic traits. The current process requires medicines to work reliably among a larger, more general clinical-trial population in order to be approved.