Rather than offer up a buffet of ideas to streamline the development of new drugs, diagnostics and medical devices, Sen. Lamar Alexander (R-Tenn.) hopes to boil down the Senate response to the House 21st Century Cures Initiative to a few meaningful ways to reduce the cost and time involved in getting a new cure from discovery to the medicine cabinet. "We don't want to waste our time. We can't do everything," he told the Senate Health, Education, Labor and Pensions Committee as he opened a hearing on advancing medical innovation. Alexander's approach is in stark contrast to the Cures Initiative, a nearly 400-page draft proposal of a plethora of ideas stemming from several roundtable discussions. For starters, Alexander suggested whittling down administrative costs that consume more than 40 percent of each research grant awarded by the NIH.

If precision medicine is to be the future of health care in the U.S., the FDA must stop dragging its feet on qualifying biomarkers necessary to develop targeted therapies and track disease advancement, according to a report released by the Manhattan Institute for Policy Research. According to Paul Howard, a senior fellow at the institute and co-author of the report, since 2008, the FDA has qualified four biomarkers. While two more are under review, 20 biomarker qualification packages have stalled at the consultation and advice stage. Yet hundreds of potential biomarkers exist that could lead to clinical trial enrichment, serve as surrogate endpoints and pinpoint safety concerns.

The Patient-Centered Outcomes Research Institute (PCORI) is living up to its legislative requirements, the Government Accountability Office reported. Established in 2010 under the Patient Protection and Affordable Care Act, PCORI is a federally funded, nonprofit corporation charged with improving the quality and relevance of comparative-effectiveness research (CER). The institute is to receive about $3.5 billion from fiscal years 2010 through 2019 for research. To date, PCORI has invested nearly $735 million in 365 CER or related research projects.